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ABSTRACT
Obesity is extremely prevalent, affecting 40.3% of adults in the United States. Advisory panels recommend a 5-10% reduction in initial weight for adults with obesity, or for those who are overweight, with a related comorbidity. This loss can significantly reduce the risk of the development and progression of type 2 diabetes and improve other cardiovascular disease (CVD) risk factors, as seen in the Diabetes Prevention Program and Look AHEAD trials. Greater reductions in weight produce even greater health improvements. Weight loss can be achieved with a comprehensive lifestyle program that consists of dietary change, increased physical activity, and behavior therapy, provided in individual or group sessions. Behavioral treatment can be combined with diets of varying macronutrient composition and dietary patterns, as long as they induce a caloric deficit. Physical activity should be gradually increased over a period of 6 months, and although it is not effective as a stand-alone intervention for inducing a clinically meaningful mean weight loss, it is very important for facilitating weight maintenance and improving health outcomes. Principles of behavioral treatment include self-monitoring, stimulus control, and goal setting. Weight regain is common after an initial treatment period of 6-12 months, but frequent follow-up with an interventionist, which includes at least monthly counseling, can mitigate it. Treatments delivered synchronously or asynchronously via telehealth can be more easily disseminated to larger populations and can produce clinically meaningful mean weight losses if they include content similar to that of in-person lifestyle interventions and provide personalized feedback. With the widespread interest and increasing use of obesity management medications (OMM), particularly incretin-based medications, we summarize behavioral interventions that have been tested as an adjunct to first- and second-generation OMMs and also review current best practice recommendations. For complete coverage of all related areas of Endocrinology, please visit our on-line FREE web-text, WWW.ENDOTEXT.ORG.
INTRODUCTION
Obesity, defined by a body mass index (BMI) ≥ 30 kg/m2, is a common chronic disease in the United States, affecting 40.3% of adults (1) and 19.7% of children and adolescents (2). Obesity is associated with an increased risk of developing cardiovascular disease, hypertension, dyslipidemia, and type 2 diabetes mellitus, along with other clinical conditions including metabolic dysfunction-associated steatotic liver disease, obstructive sleep apnea, and osteoarthritis (3-6). A loss of 5-10% of initial body weight improves these complications and has been recommended by expert panels sponsored by the World Health Organization (7), the National Institutes of Health (8), and several professional societies. Losses of this magnitude can be achieved with a high-intensity lifestyle intervention (also known as lifestyle modification or behavioral weight loss treatment), as described in the Guidelines for the Management of Overweight and Obesity in Adults (i.e., Obesity Guidelines) developed by The American College of Cardiology, American Heart Association, and the Obesity Society (9).
Comprehensive lifestyle interventions include three key components: diet, physical activity, and behavior therapy. This chapter describes each intervention component and reviews the short-term and long-term effectiveness of this approach. Lifestyle interventions have traditionally been delivered in 15-90 minutes, in-person, group or individual sessions by a trained interventionist (usually a registered dietitian, psychologist, exercise physiologist, or other health-care professional). Although this is by far the best-researched treatment modality, the past two decades have seen an exponential growth in digital and other remote treatment approaches which we review. Given the growing interest and use of obesity management medications (OMMs), especially incretin-based therapies, we provide an overview of lifestyle interventions that have been evaluated alongside both first- and second-generation OMMs and also summarize clinical practice recommendations.
EFFICACY OF HIGH-INTENSITY, IN-PERSON LIFESTYLE INTERVENTION PROGRAMS
Interventions categorized as “high-intensity” by the Obesity Guidelines provide a minimum of 14 treatment sessions during the first 6 months (9). Maintenance sessions may be delivered at a reduced frequency (e.g., monthly) thereafter. In trials conducted in academic medical centers, participants treated by a 1200-1500 kcal/day diet, combined with regular exercise, and a comprehensive program of group or individual behavior modification, lose an average of 5-8% of initial weight in 6 months (8-10), and approximately 60-65% of patients lose ≥5% of their initial weight. The lifestyle programs provided in the Diabetes Prevention Program and the Look AHEAD study provide excellent examples of high-intensity interventions.
Diabetes Prevention Program
In the Diabetes Prevention Program (DPP), more than 3,200 participants with obesity or overweight and impaired glucose tolerance were randomly assigned to a placebo, metformin (850 mg twice daily), or an intensive lifestyle intervention, with the goal of inducing a 7% weight loss in the latter group (11). Participants in the lifestyle intervention group were given 16 individual on-site counseling sessions with a registered dietitian in the first 24 weeks, followed by at least one contact every other month for the remainder of the study. They were prescribed a low-fat, reduced-calorie diet (1200-2000 kcal/day, depending on initial body weight), and 150 min/week of physical activity. After an average of 2.8 years, participants in the lifestyle intervention group lost a mean of 5.6 kg, compared to 0.1 and 2.1 kg in the placebo and metformin groups, respectively. The 5.6 kg weight loss translated to a 58% relative reduction in the risk of developing type 2 diabetes. Ten years after randomization, the lifestyle intervention group had regained most of their lost weight, but their incidence of type 2 diabetes remained 34% below that in the placebo group (12).
Look AHEAD (Action for Health in Diabetes) Study
The Look AHEAD study enrolled more than 5,100 individuals with overweight/obesity and type 2 diabetes mellitus, and participants were randomly assigned to a diabetes support and education (DSE) group or an intensive lifestyle intervention (ILI) group, with the aim of examining the long-term effects of a 7% weight loss on cardiovascular morbidity and mortality (13). Participants randomized to the DSE group received three group education sessions each year in the first 4 years, whereas participants in the ILI group received treatment similar to that in the DPP with some modification. During the first 6 months, ILI participants had 3 weekly group treatment sessions and one individual visit per month and replaced two meals per day with a liquid supplement (i.e., shake). They were instructed to consume 1200-1800 kcal/day (with calories adjusted based on initial weight). During months 7 to 12, ILI participants had two group sessions and one individual visit each month and used meal replacements for one meal per day. For the next 3 years, participants were offered one individual on-site visit and one phone (or e-mail) contact per month.
At 1 year, ILI participants lost 8.6% of baseline weight, compared with 0.6% for the DSE group (14), and at year 4, mean weight losses were 4.7% versus 1.1%, respectively (15). These latter losses were maintained at 8 years, at which time patients in the ILI group lost 4.7% of initial weight, compared with 2.1% for DSE participants (16). The study was ended at a mean of 9.6 years of post-randomization follow-up because there were no differences in cardiovascular morbidity and mortality between groups (13). However, patients in ILI, compared to DSE, had significantly greater reductions in HbA1C, lost more weight, had larger improvements in cardiovascular disease risk factors (i.e., reductions in systolic and diastolic blood pressure and levels of triglycerides), and used fewer diabetes, hypertension, and lipid-lowering medications. Analyses showed that the greater the weight loss, the greater the improvements in those risk factors (17).
Compared to DSE, additional benefits in the ILI group included greater reduction of depression symptoms and remission or reduced severity of obstructive sleep apnea. A follow-up assessment of ILI and DSE participants 16 years post-randomization continued to reveal no significant differences in CVD morbidity and mortality between the two groups (18).
The Look AHEAD and DPP studies both demonstrate that weight loss and long-term benefits to health can be achieved through participation in a lifestyle modification program. These programs have been translated to primary care (19) and community settings (20), as well as digital (21, 22) and artificial intelligence platforms (23).
LIFESTYLE INTERVENTION COMPONENTS
Dietary Recommendations
The primary goal of the dietary prescription in a behavioral weight loss program is to induce a 500-750 kcal/day deficit. For individuals <114 kg (250 lb), this involves consuming about 1200-1500 kcal/day, while for those ≥114 kg the goal is about 1500-1800 kcal/day (9, 10). The ideal dietary pattern, approach, and macronutrient composition for producing weight loss has been studied extensively (24). The outcomes of comparative studies of different types of diets have consistently concluded that adequate weight loss depends less on the macronutrient content of the diet and more on the caloric deficit. The POUNDS LOST trial supported this conclusion in a large, 2-year study that randomized patients to one of four diets with different macronutrient compositions, varying in proportions of fat, protein, and carbohydrate content (fat/protein/carbohydrate content: 20/15/65%; 20/25/55%; 40/15/45%; and 40/25/35%, respectively) (25). The study showed no difference in the amount of weight lost among the diet groups, all of which were designed to produce an energy deficit of approximately 750 kcal per day. Several other studies have also found that different dietary approaches produced weight losses that were comparable, provided there was a sufficient reduction in calories (26, 27).
Intermittent fasting diets include periods of fasting alternating with times of eating and can be classified broadly as time-restricted eating, alternate-day fasting, and whole-day fasting. Studies comparing these strategies to traditional continuous calorie restriction have generally demonstrated similar benefits (28, 29). The use of portion-controlled diets have been shown to facilitate greater weight losses than isocaloric diets comprised of conventional foods, but this is primarily due to improved adherence to calorie goals and not to their macronutrient profile (30).
Precision nutrition interventions have generated enthusiasm but thus far results from randomized controlled trials have not demonstrated improved outcomes versus standardized approaches. For example, a precision nutrition intervention that provided a personalized diet for reducing postprandial glycemic response to foods based on participants’ anthropometrics, blood tests, lifestyle features, and microbiome resulted in similar weight loss as a standardized low-fat diet at 6 months (31). Because it appears that caloric restriction contributes to weight loss more than the macronutrient composition or timing of the diet, diets should be chosen using shared decision-making based on patients’ personal preferences and by the presence of comorbid conditions.
Physical Activity Recommendations
Physical activity is an important component of a comprehensive lifestyle intervention, in which participants are typically instructed to increase their physical activity gradually to approximately 150-180 min/week over the first 6 months. This goal can be achieved by engaging in moderate physical activity (e.g., brisk walking) for 30 minutes on 5 days per week (9, 10). Physical activity can be increased by incorporating short bouts of lifestyle activity into individuals’ daily routines, such as increasing the amount of daily walking or using the stairs when possible, or by longer bouts of structured physical activity (e.g., at the gym). Individuals should be encouraged to engage in physical activities that they enjoy rather than be prescribed a particular activity. The recommended physical activity levels for facilitating long-term weight management are higher (200-300 min/week) than those for losing weight (32).
PHYSICAL ACTIVITY AND WEIGHT LOSS
Physical activity has a modest impact on weight loss when compared with the effect of caloric restriction (32). This was demonstrated in a 12-week study in which participants achieved losses of 0.3-0.6% (male vs female) of initial weight from physical activity alone, compared to 5.5-8.4% (female vs male) and 7.5-11.4% (female vs male) losses for participants who reduced their calorie intake and those who changed both diet and physical activity, respectively (33). The exercise performed in this study consisted of 30 min/day of moderate activity on 5 days per week. Similarly, Wing et al (34) reported weight losses of 2.1, 9.1, and 10.3 kg after 6 months in participants assigned to physical activity alone, diet alone, and diet plus physical activity groups, respectively, all of whom were provided behavioral intervention.
PHYSICAL ACTIVITY AND WEIGHT LOSS MAINTENANCE
Although exercise has a limited impact on weight loss during the initial phase of treatment, it plays an important role in weight loss maintenance. Several studies have shown that the more physical activity the patient engages in, the better the maintenance of lost weight (35, 36). Jakicic et al (36), in a secondary analysis of a randomized controlled trial, demonstrated that women who exercised more than 200 min/week maintained greater weight losses than those who exercised 150-199 min/week or <150 min/week. Data from the National Weight Control Registry have also provided evidence that high levels of physical activity are characteristic of individuals who report long-term, sustained weight loss (37). The Registry follows patients who have lost a minimum of 13.6 kg (i.e., 30 lb.) in 6 months and maintained this loss for at least 1 year. Of these successful weight loss maintainers, 91% reported that they were exercising consistently, with women expending 2,545 kcal/week and men 3,293 kcal/week (38). Based on these findings and other evidence, the current recommendation by the American College of Sports Medicine is that, for weight maintenance, individuals should exercise at a minimum level equivalent to an hour of brisk walking per day (32).
PHYSICAL ACTIVITY AND CARDIOVASCULAR HEALTH
Physical activity also is crucial for improving cardiovascular health for individuals regardless of weight status. Even in the absence of significant weight loss, regular bouts of physical activity have been found to reduce blood pressure (39), lipids (40), and visceral fat (41), the latter of which is associated with improved glucose tolerance and insulin sensitivity in individuals without diabetes and glycemic control in patients with type 2 diabetes (42, 43). Additional benefits of physical activity are enhanced physical function and brain, cognitive, and psychological health (44-46). These findings indicate that all individuals should increase their physical activity to improve their health, regardless of its impact on body weight.
Principles of Behavior Therapy
The third component of a lifestyle intervention is behavior therapy, which refers to a set of principles and techniques used to help patients adopt dietary and activity recommendations. Behavioral principles were first applied to the treatment of obesity in the 1960’s and early 1970’s and, since then, have been developed into a program of behavioral and cognitive strategies (10, 47). The core components of behavior therapy include goal setting, self-monitoring, stimulus control, and problem solving.
GOAL SETTING
In behavioral weight loss treatment, goal setting refers to setting specific targets for making changes to the patient’s calorie intake, physical activity, and eating and exercise habits (48, 49). Early goal achievement is associated with greater weight loss (50). Goals should be “SMART,” specific, measurable, achievable, relevant, and time-bound. Patients are encouraged to have a target range for their total daily caloric intake (or other dietary goals), a daily or weekly exercise goal in minutes, and short- and long-term weight loss goals. Other behavioral goals are introduced as treatment proceeds. Patients should set behavioral goals that facilitate their losing about 0.5-1.0 kg per week, for a total loss of 5-10 percent of initial body weight at the end of the weight loss phase (at about 6 months). These goals should be trackable and specify when and how the goal will be accomplished. During a typical treatment session, the lifestyle interventionist reviews each patient’s progress in achieving goals from the previous session and helps the patient set new goals. If the goals from a previous session are not met, the interventionist assists individuals with identifying and reducing barriers to goal achievement or with modifying their goals accordingly. In group programs, this information is often shared with the entire group to further increase accountability and support problem-solving.
SELF-MONITORING
Monitoring target behaviors in a systematic way is a crucial aspect of the behavioral approach to weight loss. Self-monitoring provides instant feedback about the effectiveness of behavior change efforts. It can answer the most important question about behaviors: are they getting better, staying the same, or getting worse? Daily records also function to increase patients’ awareness of target behaviors and their effect on weight change. Self-monitoring is strongly linked to success in weight loss. Individuals who regularly monitor their weight, activity levels, and eating patterns usually achieve the largest weight losses (51-53).
Patients are encouraged to record all foods and beverages consumed and their calorie content (or an alternative dietary target) to determine if they have met their dietary goals. A thorough self-monitoring report might also include the individual’s feelings that day, particularly those that were associated with excess or unplanned eating, or other identified triggers for overeating. Tracking the minutes and type of physical activity or step counts can be used to monitor improvements in the patient’s activity level. Patients also should be instructed to weigh themselves regularly at home, at least once per week, and to keep a record of their weekly weights.
Although some patients prefer traditional paper records, the majority now track these targets using smartphone applications (apps) and other digital devices such as wearable physical activity trackers and “smart” scales that automatically record body weight. Novel tracking tools such as digital food photography and bite counting devices may further reduce the burden of active recording, but some studies have suggested that these methods are less strongly correlated with weight loss and may produce smaller mean losses than active recording methods (54).
In lifestyle intervention programs, patients review their self-monitoring records with an interventionist who helps them assess their progress, set goals, and problem solve barriers to goal adherence. Individuals often underestimate calorie intake (55), and interventionists can help patients who report meeting their calorie goals but do not lose weight to identify additional sources of caloric intake. These may come from underestimates of portion sizes or hidden sources of fat and/or sugar intake. Interventionists also can help patients address barriers to effective self-monitoring, or set more flexible self-monitoring goals (e.g., record on fewer days per week), as appropriate.
STIMULUS CONTROL
The goal of stimulus control is to alter external and internal cues that influence eating and exercise behaviors (10, 48, 49). In classical conditioning, cues develop when two stimuli (e.g., objects, activities) are repeatedly experienced together, which creates an association between the two. The appearance of one stimulus can invoke the other stimulus. Food cues are cues that cause an individual to think about eating or about specific foods. These may include external cues, such as the sight or smell of food, or an activity that is frequently engaged in while eating, such as watching television. Internal food cues include both physical sensations and thoughts or emotions that the person has come to associate with eating. Similarly, activity cues include internal and external experiences that the person has come to associate either with being active (e.g., the sight of sneakers by the door) or being inactive (e.g., the couch).
Patients learn to reduce negative food and activity cues—either by avoiding problem cues or by creating new habits in response to those cues—and to enhance cues for desired behaviors. Examples of cue reduction include avoiding places that sell or serve high-calorie foods, staying away from all-you-can-eat buffets, eating only at the table without screens (e.g., phone or television), unfollowing food-triggering social media accounts, and keeping any high-calorie foods that are associated with overeating out of the house. The patient can instead be encouraged to buy single portions of these foods on planned occasions. For cues that cannot be avoided, patients are encouraged to identify an appropriate alternative behavior, such as taking a 5-minute break instead of snacking when bored at work. To increase cues for healthy eating, patients can be taught to improve the visibility and availability of healthy, low-calorie foods in their home or workplace, such as by storing these foods at eye-level. They can also add cues that promote physical activity, such as arranging to walk at a certain time every day with a partner or leaving their gym bag in their car so that it is the first thing that they see when they leave work. By making these changes, patients can ensure that their work and home environments facilitate (rather than interfere with) weight loss.
COGNITIVE STRATEGIES
Strategies from cognitive-behavioral therapy (CBT) have been incorporated into many lifestyle interventions. CBT focuses on identifying, testing, and correcting maladaptive thoughts in order to change emotions or behavior. For example, thoughts like “I’ll never reach my weight loss goal; I might as well eat whatever I want.”) can reduce the likelihood that patients will adhere to their dietary goals. Patients are taught to create a rational response to these negative thoughts, such as by noting that “My weight loss may be slower than I would like, but continuing to make healthy choices gives me the best chance of long-term success,” or by highlighting some of the benefits that they experience when they make healthier eating choices (10, 48, 49).
Some lifestyle programs also have incorporated strategies from motivational interviewing that are designed to help patients resolve ambivalence about the costs and benefits of behavior change, identify reasons for change, and improve self-efficacy (56). Alternative cognitive strategies derived from mindfulness and acceptance-based psychological treatments have also been incorporated into obesity treatment (57). These treatments promote non- judgmental, present-moment awareness and willingness to experience discomfort in order to pursue long-term goals rather than cognitive change. Thus far, programs that place a significant emphasis on any of these cognitive techniques have not consistently enhanced weight loss when compared to standard lifestyle interventions, and those shown to be superior have only increased weight loss by 1-2 kg (58). However, because fewer studies have incorporated these techniques into comprehensive, high-intensity lifestyle interventions, they remain potential targets for future research.
STRUCTURE OF IN-PERSON BEHAVIORAL TREATMENT: SHORT- AND LONG-TERM
The lifestyle interventions provided in studies like the DPP and Look AHEAD followed a structured curriculum that gradually introduced different behavior change skills. Detailed treatment descriptions can be obtained from the intervention manuals for these two studies (48, 49) or an adaptation of the DPP protocol provided by Wadden, Tsai, and Tronieri for in-person delivery in primary care settings (59). Behavioral weight loss interventions are most commonly delivered in group sessions, which have been found to be as effective as individual counseling for weight loss (60, 61). It may be that any weight loss benefit of receiving personalized support with individual counseling is roughly equivalent to the benefits of a greater degree of social support, empathic understanding, and healthy competition among group members. However, group treatment is more cost effective than individual counseling.
The frequency and duration of contact during the weight loss period are additional predictors of weight loss success with behavioral obesity treatment (9, 60). This benefit is apparent in trials comparing high-intensity lifestyle intervention programs to programs that provided identical dietary and physical activity recommendations with a lower session frequency, as well as in systematic reviews and meta-analyses of the efficacy of lifestyle interventions. For example, in a study by Perri and colleagues (62) that compared three different visit schedules to a control condition, the group that received 8 treatment sessions in the first 6 months had a weight loss of 3.5 kg at month 24 that did not differ significantly from the 2.9 kg loss of the control group, whereas patients who received 16 sessions had a loss of 6.7 kg that was superior to both groups. Of note, the group that received 24 sessions in the first 6 month did not differ in weight loss from the 16- session group at any time, suggesting that there may not be a benefit of further increasing visit intensity (while increasing costs). In 2012, the United States Preventative Services Task Force recommended that weight loss programs include at least 12-26 intervention sessions per year for optimal weight loss (63). This recommendation was based on their systematic review, which reported weight losses of 4 to 7 kg for programs with that level of intensity compared to 1.5 to 4 kg in programs offering fewer than 12 sessions (60). These findings were consistent with the Obesity Guideline’s conclusion that programs that provided at least 14 sessions in the first 6 months produce a weight loss of 5 to 8 kg, those that provide 6-13 sessions (1-2 sessions per month) produce a 2 to 4 kg loss, and those that provide less than monthly sessions induce minimal weight loss (9).
For weight loss maintenance, frequent (monthly or twice monthly), long-term contact with an interventionist is the most successful method for preventing weight regain. Weight loss maintenance sessions are important for providing individuals with the support and motivation needed to continue with the behavior changes they have made, such as engaging in physical activity, eating a low- calorie diet, and self-monitoring. Wing et al (64) demonstrated that monthly in-person sessions were more effective in preventing weight regain over 18 months of intervention than was an education-control group or an internet-based intervention. Participants in the three groups regained an average of 2.5, 4.9, and 4.7 kg, respectively, after an initial weight loss of 19 kg.
REMOTELY-DELIVERED LIFESTYLE MODIFICATION INTERVENTIONS
In-person interventions can be costly because they require adequate facilities for hosting the intervention, staff for checking in patients, and the time of trained providers to deliver the intervention. Travel time also can represent a cost and inconvenience for patients, and many individuals, particularly those in rural and economically disadvantaged urban areas, do not have adequate access to evidence-based care. Over the past two decades, a growing body of research has investigated the use of telephone, computer, smartphone, and other technology-based methods for delivering lifestyle interventions to patients. Larger numbers of individuals can be reached with these methods at a cost that is significantly less than that of in-person interventions, particularly if little to no provider input is required. The COVID-19 pandemic further highlighted the need to identify effective ways of delivering lifestyle interventions remotely, as in-person treatment programs were either suspended or quickly migrated to phone calls or videoconferencing platforms due to stay-at-home orders and social distancing policies.
Telehealth Delivery
Remote interventions delivered live by a provider via telephone or videoconferencing, often referred to as telehealth, produce weight loss outcomes that are most consistent with those of in-person interventions. This delivery method improves treatment access and reduces travel time and cost for participants, but it has minimal impact on provider time and training costs. Several large trials have compared individual or group telephone calls to in-person treatment delivery. For example, Donnelly et al (65) achieved median 26-week weight losses of 13.0% with group conference calls which did not differ from the 12.7% loss of patients who attended on-site groups (both also received a 12-week 1200-1500 kcal/day portion- controlled diet). Similarly, Appel et al (66) showed comparable weight losses at 24 months for participants who received telephone-delivered sessions compared to those that received in-person visits (4.6 kg and 5.1 kg, respectively). Telephone-based interventions also have shown to be effective for weight maintenance and appear to attenuate weight regain to a similar degree as ongoing in-person sessions (61, 64, 67).
In the past several years, videoconferencing platforms have become more widely accessible. These platforms provide the capability for remotely delivered face-to-face interactions, which allow for visual demonstrations and may enhance feelings of connection with the interventionist and/or group (68). This delivery format has yet to be compared to in-person intervention in large randomized trials; however, pilot and short-term studies (69, 70), suggest that videoconferencing may produce weight losses that are similar in magnitude to those of in-person interventions.
Digital Delivery via the Internet or Smartphone
Digitally-delivered programs in which standardized intervention content is delivered via digitally- accessible articles, messages (e.g., e-mail or SMS), or pre-recorded videos further reduce costs and interventionist burden when compared to live interventionist delivery either in person or through telehealth. Some of the earliest interventions with digital session content were developed for delivery via the internet. In an early study, Tate et al. (71) demonstrated that an Internet-based behavioral approach consisting of email-based lessons, online self-monitoring of diet and physical activity, and e- mail feedback from an interventionist produced greater 6-month weight losses of 4.1 kg compared to the 1.6 kg loss achieved by participants who received an educational program (i.e., Internet resources with no specific instruction in changing eating and activity habits). As technology has evolved, digital programs have more typically been developed for mobile delivery via smartphone apps or in formats accessible via either the computer or smartphone. Intervention delivery via text message also has been evaluated, but typically produces small mean reduction averaging 2.3 kg for weight loss and 0.7 kg for weight loss maintenance (72).
Relatively few studies have directly compared the efficacy of digitally delivered to in-person treatment. Harvey-Berino and colleagues (73) compared the same 24-session group lifestyle intervention delivered weekly: 1) in-person; 2) by internet (including online content, self-monitoring tools, and weekly chat groups); or 3) in a hybrid format (the internet program with monthly in-person meetings). Weight losses were 8.0, 5.5, and 6.0 kg, respectively, with in-person treatment superior to the other two groups. These findings, along with the results of multiple systematic reviews, suggest that the strongest digitally-delivered interventions produce short-term losses that are at least 20-35% smaller than those achieved with in-person counseling (74, 75). Such interventions are valuable given their wide reach and low cost, and the difference between the results of these digital interventions and in-person programs is likely to wane over time with regain. However, the average effect of digitally-delivered interventions is small (1-3 kg), highlighting the importance of identifying features associated with effective interventions (74, 75).
The provision of tailored feedback is a commonly identified characteristic that differentiates effective from less effective digital interventions and can help to enhance engagement with digital health interventions (75). In earlier digital trials, feedback was provided directly by an interventionist. Increasingly, digital programs provide fully-automated, personalized feedback, generated from algorithms that analyze participants’ self-monitoring data. This tailored automated feedback appears to produce weight losses that are similar in magnitude to programs with interventionist-delivered feedback (76, 77). A 2015 study by Martin and colleagues (78) evaluated a combined approach providing participants with highly personalized automated and weekly interventionist-initiated feedback (by phone, email, or app), in addition to app-based lesson materials, in an effort to maximize weight loss. Participants were given activity monitors and smart scales, and the app delivered automated graphic feedback comparing their physical activity and weight loss to expected targets (calculated based on their starting weight and calorie prescription). If participants’ weight losses fell outside of the expected range, they were prompted to select a behavioral strategy (e.g., use portion- controlled foods) to get back on track. In this 12-week pilot study, intervention participants lost 9.4 kg compared to 0.6 kg in the control group. Additional research is investigating the potential for just-in-time adaptive interventions (JITAIs) that use machine learning to identify individual risk factors for behavioral lapses and provide tailored feedback and intervention strategies at the times when an individual is most at risk. An initial evaluation of a JITAI intervention that was designed to promote dietary adherence by predicting dietary lapses produced a 10-week weight loss of 4.7% when combined with an app-based commercial weight loss program (79).
User engagement has been found to correlate with weight loss in several digital trials, making it an important target for improving the efficacy of digital interventions. One approach for enhancing engagement is to increase the interactive quality of the digital program. Thomas, Leahey, and Wing (80) tested the efficacy of a 12-week online program that provided interactive lessons that incorporated videos, quizzes, and practical exercises. The program also provided self-monitoring tools and fully automated weekly feedback based on participants’ recorded data. At 6 months, intervention participants lost 5.4 kg, compared to 1.3 kg for control participants who received static lessons about the benefits of weight loss (without behavioral strategies). Other efforts to increase interactive engagement have incorporated lifestyle programs into social media platforms, virtual reality, or online games, and several of these interventions also have produced mean weight losses of 4-5 kg (81). A study by Vaz and colleagues (82) combined several of these techniques into a smartphone app that provided automated feedback on weight and physical activity recorded via smart scale and activity tracker, respectively; text- and app-initiated engagement prompts from an interventionist; social networking and sharing of food and exercise data; and peer competitions based on dietary and physical activity adherence. The app produced a mean weight loss of 7.2 kg at 6 months, which was 4.2 kg larger than a control group that received two weight management visits. A trial by Thomas et al., (83) tested an automated online behavioral treatment for weight loss maintenance that was pragmatically implemented in primary care. Participants lost an average of 3.6 kg during a 3-month, fully automated online weight loss program and were then randomized to one of three interventions for weight maintenance: control (monthly online newsletters), monthly intervention (9 monthly video lessons with self-monitoring and automated feedback), or refresher intervention (introductory session and two 4-week periods of lessons and self-monitoring with automated feedback at 7 and 10 months). At 12 months, participants in the control group had regained 1.3 kg, which was significantly more than the regain of 0.4 kg in the monthly and 0.5 kg in the refresher groups. At 24 months, the control group had regained 3.0 kg, which was greater than the regain of 0.9 kg in the monthly group and 1.1 kg in the refresher group.
Results have been promising for online and app-based commercial programs that provide comprehensive intervention content. For example, average losses of 5.1% of initial weight were achieved at 6 months in a single-arm trial evaluating the digital commercial weight loss program, WeightWatchers (84). A digital version of the Diabetes Prevention Program, the Omada Health Program, produced a mean weight loss of 5.5% at 12 months (22). Overall, these findings suggest that providers can support their patients’ weight loss by helping them to identify digital programs that offer comprehensive session content and personalized feedback.
LIFESTYLE MODIFICATION WITH FIRST-GENERATION OBESITY MANAGEMENT MEDICATIONS (OMMS)
To enhance the effectiveness of lifestyle treatments and support long-term weight loss maintenance, several studies have explored the addition of first-generation OMMs to lifestyle modification. The FDA mandates that clinical trials for OMMs include a standard diet and exercise program to be used after approval, typically involving monthly check-ins to support adherence to a reduced-calorie diet and regular physical activity. All OMMs have been FDA approved as an adjunct to a reduced-calorie diet and increased physical activity.
The first-generation OMMs (i.e., phentermine, orlistat, phentermine/topiramate extended-release, naltrexone/bupropion extended-release, and liraglutide) generally lead to clinically significant, albeit modest, weight loss results (i.e., average losses of less than 10% of initial weight). Research has suggested that when first-generation OMMs are paired with more intensive lifestyle interventions, they can yield greater weight loss compared to medication combined with less intensive intervention. For example, in the CONTRAVE Obesity Research-II (COR-II) study, participants were randomized to naltrexone sustained-release (SR) (32 mg/day) plus bupropion SR (360 mg/day) (NB32) or placebo for up to 56 weeks. Participants also received brief counseling sessions every 12 weeks (5 sessions total). At week 52, the NB32 group achieved an average 6.4% reduction in initial weight. (85). Whereas, in the COR-BMOD trial, participants received naltrexone SR 32 mg/day, combined with bupropion SR 360 mg/day with a more intensive behavioral modification program consisting of 28 sessions. This combined approach resulted in a mean loss of 9.3% of initial weight (86).
LIFESTYLE MODIFICATION WITH SECOND-GENERATION OBESITY MANAGEMENT MEDICATIONS (OMMS)
Incretin-based therapies have shown significant benefits for obesity and related diseases. Semaglutide 2.4 mg, a weekly glucagon-like peptide-1 (GLP-1) receptor agonist, and tirzepatide 10-15 mg, a weekly combined GLP-1 and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist, can decrease appetite (87), reduce calorie intake (88), and promote body weight reductions of about 15% and 20% of initial weight (89, 90). In the seminal Phase 3 trials of semaglutide and tirzepatide for chronic weight management, counseling was provided approximately every 4 weeks during dose titration and then continued to be provided every 4 weeks with semaglutide or 12 weeks with tirzepatide (89, 90). Participants were advised to reduce their calorie intake (e.g., 500 kcal/day deficit) and increase their physical activity (e.g., ≥150 minutes/week).
Unlike the additional effect of lifestyle interventions with first-generation OMMs, second-generation OMMs appear to require less intensive lifestyle modification to achieve substantial weight loss. In the STEP 3 trial, increasing semaglutide particicipants’ lifestyle intervention to 30 sessions (including 8 weeks of a meal replacement diet) resulted in a 16% initial weight loss, which was only 1.1 percentage points greater than the 14.9% loss achieved in STEP 1 which provided only 18 lifestyle sessions (91).
Currently, there are no established dietary or exercise guidelines for patients on incretin-based medications. However, several clinical practice guidelines and recommendations have been published in this area (92-95). The effectiveness of incretin-based medications invites a shift in lifestyle interventions, transitioning from a focus on caloric deficit to overall health improvement. Key counseling topics for patients using these medications should address managing gastrointestinal side effects, preserving muscle mass and function, preventing nutritional deficiencies, and maintaining weight loss. Incretin medications impact dietary habits by reducing hunger and increasing satiation, which engenders a reduction in calorie intake (87, 88). Patients should be guided in evaluating their eating patterns, including appetite, meal timing, protein and fiber intake, and hydration. Nutritional assessments for potential nutrient deficiencies are particularly relevant for those at risk (e.g., older adults, those with a history of bariatric surgery). Diet plans for these patients should emphasize sustainable, nutrient-dense foods while addressing adverse effects. A daily protein intake of at least 60-75 grams and up to 1.2 to 1.6 grams of protein per kg of body weight (96) is recommended to help mitigate loss of muscle mass during weight loss. To lessen nausea and other gastrointestinal effects, patients should be advised to avoid high-fat and spicy foods, eat smaller, frequent meals, consume adequate amounts of fiber, stay well hydrated, and limit alcohol and carbonated drinks. Physical activity is vital for overall health. Patients should aim for at least 150 minutes of moderate aerobic activity per week, along with resistance training sessions two times weekly. Combining incretin therapies with physical activity may improve fitness, function, and health more than medication alone, although further research is needed.
CONCLUSION
There is clear evidence that intensive lifestyle interventions are effective in helping patients with obesity to lose 5-10% of initial body weight, a loss that is associated with improvements in CVD risk factors and other obesity-related comorbidities. Lifestyle approaches emphasize prescriptions for dietary intake, increased physical activity, and behavioral skills such as self-monitoring. Traditionally, these interventions have been delivered in-person by a trained interventionist, which limits their potential dissemination. It is also possible to achieve a clinically meaningful weight loss with digitally-delivered programs that include little to no contact from an interventionist, provided the intervention provides comprehensive session content, tailored feedback, and features that promote user engagement.
One of the most challenging aspects of behavioral weight control is keeping off lost weight. Several strategies can facilitate this goal, including maintaining patient-provider contact beyond the initial weight loss intervention, either in-person or remotely, and prescribing high levels of physical activity after weight is lost in the first 6 months. In addition, the more that patients practice the skills used by participants in the National Weight Control Registry, the more likely they will be to maintain their weight loss. First-generation OMMs produce modest, albeit clinically significant weight losses and demonstrate greater effectiveness when combined with intensive lifestyle interventions. In contrast, second-generation incretin-based therapies result in substantially greater weight reductions, with more intensive lifestyle modification offering limited additional weight loss benefit, providing the opportunity to shift the focus of behavioral counseling away from caloric restriction alone and toward optimizing overall health.
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- ABSTRACT
- INTRODUCTION
- EFFICACY OF HIGH-INTENSITY, IN-PERSON LIFESTYLE INTERVENTION PROGRAMS
- LIFESTYLE INTERVENTION COMPONENTS
- STRUCTURE OF IN-PERSON BEHAVIORAL TREATMENT: SHORT- AND LONG-TERM
- REMOTELY-DELIVERED LIFESTYLE MODIFICATION INTERVENTIONS
- LIFESTYLE MODIFICATION WITH FIRST-GENERATION OBESITY MANAGEMENT MEDICATIONS (OMMS)
- LIFESTYLE MODIFICATION WITH SECOND-GENERATION OBESITY MANAGEMENT MEDICATIONS (OMMS)
- CONCLUSION
- REFERENCES
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