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Whitlock EP, Williams SB, Gold R, et al. Screening and Interventions for Childhood Overweight [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2005 Jul. (Evidence Syntheses, No. 36.)

  • This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

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Screening and Interventions for Childhood Overweight [Internet].

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Appendix L. Evidence Table: Intervention Trials 2001-Present

StudyMethodsParticipantsInterventionsOutcomesResultsAdverse EffectsComment
Berkowitz et al 2003 1 Random allocation : Yes, but neither randomization procedure nor allocation concealment are described. N randomized, completed: 82, 74 (completed 6 mos) Description of intervention: Randomized, double-blinded, placebo-controlled trial of pharmacological agent sibutramine plus comprehensive, family-based, behavioral wt loss program vs. behavioral wt loss program alone. Weight status: Weight, height, waist circumference Results at 6 months: Elevated BP and/or pulse rate @6 mos: Quality: Good
Setting : University-based specialty research clinic Blinding : Yes, participants, parents, all study personnel. Only research pharmacist was aware of treatment status Age range: Exp: Time points when weight was measured: Change in initial BMI (%): Comp: 0/39 (0%) Financial deposits: NR
Location: Philadelphia Length of Intervention and f/u: 6 mos of RCT + 6 mos during which all participants received sibutramine (open label extension) Eligible: ages 13–17 yrs (only postmenarcheal girls) Pharmacological treatment : Wk 1 - placebo (all);Baseline, months 3,6,9, plus at each treatment visitExp: -8.5 %(6.8)Exp: 5/43 (12%) Financial disclosures: Investigators have served as consultants, on the speakers bureau, and have received funding from Knoll Pharmaceutical and Abbott Laboratories.
Unit of allocation: individual adolescents Actual: 14.1 yrs (1.2)Wk 2 – 5 mg sibutramine QD; Behavioral: Comp: -4.0 %(5.4)P=0.06
Unit of analysis: individuals % male: 33%Wk 3 – 10 mg/day*; Diet- NRMean difference (95%CI): 4.5 % (1.8–7.2), p = 0.001During first 6 months, 19/43 (44%) patients required reduction in dose of sibutramine due to increased BP or pulse rate.
Protection against contamination: Control and intervention subjects differed only by receiving sibutramine vs. placebo % minority or non-white: 45%Wk 7 – 15 mg/day* PA- NR Weight: During entire study, 5/64 (8%) patients had marked and sustained increases in BP (≥ 10 mmHg) that required discontinuation of medication.
Drop outs - 9.8% Weight entry criteria: BMI 32–44*unless BP or HR elevated Physiological: Exp: -7.8 kg (6.3) Other reasons for discontinuing medication (n):
Weight on entry: Behavioral treatment : Diet: 1200–1500 kcal/d, 30% fat/15% protein/ remainder CHO. Physical activity: ≥ 120 min/wk walking or other aerobic activity. Daily eating and activity logs submitted. Parents met separately from children on same schedule. Lipids/ lipoproteins: yes, reported*Comp: -3.2 kg (6.1)Ecchymoses (2);
BMI: 37.8 (3.8) Comp: Glucose tolerance: yes, reported* (fasting serum glucose & insulin levels, HOMA)Mean difference (95% CI): 4.6 kg (2.0–7.4), p=0.001Ventricular premature complexes (1);
BMI z-score: 2.4 (0.2) Pharmacological treatment: Placebo capsules identical in appearance to sibutramine were administered on same schedule as experimental group. blood pressure: yes, reported*(systolic BP diastolic BP) Waist circumference: Rash (1)
Recruitment pool: NR Behavioral treatment: Same as experimental group. physical fitness: NRExp: -8.2 cm (6.9)
Intensity level of intervention Other: Comp: -2.8 cm (5.6)
group vs. individual : groupECGMean difference (95% CI): 5.4 cm (2.5–8.2), p < 0.001
# sessions, over what time period: Pulse rate* Reduction in initial BMI, ≥5%
Phase I: 19 sessions Over 6 months;Correlation between %ΔBMI and physiologic outcomesExp: 27/43 (63%)
( Phase II: 9 sessions over 6 months)*= treatment groups lumped together & only completers are analyzedComp: 14/39 (36%)
length of sessions: NR Adverse Events: Yes, reportedOR: 3.0 (1.2–7.4)
total contact time (min): unable to calculate Health outcomes: NRχ2=5.92, p=0.02
Primary care feasible/referable? - Yes, referable Others: Reduction in initial BMI, ≥10%
-Adherence to lifestyle programExp: 17/43 (40%)
-Adherence to medicationComp: 6/39 (15%)
-HungerOR: 3.6 (1.2–10.4)
χ2=5.91, p=0.02
Reduction in initial BMI, ≥15%
Exp: 8/43 (19%)
Comp: 1/39 (3%)
OR: 8.7(1.0–73.0)
χ2=5.39,p=0.02
Ebbeling et al 2003 2 Random allocation: Yes, but neither randomization procedure nor allocation concealment are described. N randomized, completed: 16, 14 Description of intervention: Randomized controlled trial of reduced glycemic load diet vs. conventional reduced fat diet. For both groups, educational and behavioral components of treatment delivered using a social cognitive theory conceptual framework. Weight status: Total body mass and fat mass measured by dual-energy x-ray absorptiometry, ht using a wall-mounted stadiometer. Change in BMI: Did not assess Quality: Fair
Setting: Research clinic Blinding: (children, providers, outcome assessors): not reported Age range: 13–21 yrs Exp: reduced glycemic load diet - patients instructed to select carbohydrates characterized by low-mod glycemic index. No energy restriction. Target CHO 45–50%/fat 30–35%/ remainder protein at snacks and meals. Time points: 0, 6, 12 monthsComp: 0.6 kg/m2 (0.5) Financial deposits: NR
Location: Boston, MA Length: 6 mos of Intervention + 6 mos f/uexp: 16.9 (1.3) Comp: Conventional reduced fat diet - pts instructed to limit dietary fat, increase grains, fruits, & vegetables. Negative energy balance 250–500 kcal/day. CHO 55–60%/fat 25–30%/remainder protein. Behavioral: Exp: -1.2 kg/m2 (0.7) Financial disclosures: NR
Unit of allocation: individual adolescentscont: 15.3(0.9) Intensity level of intervention : Diet - yes, reportedP=0.02
Unit of analysis: individuals % male: 31.25% group vs. individual : NRGlycemic load (g/1000 kcal) Note: baseline group differences in fat mass were not controlled for in outcome analyses.
Protection against contamination : Yes, took several strategies to prevent % minority or non-white: 18.75% # sessions, over what time period: 12 dietary counseling sessions over 6 mos during intervention, 2 dietary counseling sessions over 6 mos during f/u.Fat (% energy)
Drop outs (%): 12.5% Weight entry criteria: BMI > 95th %ile for sex and age length of sessions: not statedEnergy (kcal)
Weight on entry: total contact time: unable to calculate PA - NR
BMI: Primary care feasible/referable: Yes, referable Physiologic:
Exp:34.9(1.0) Lipids - NR
Cont:37.1(1.2) Glucose tolerance - Yes, reported (HOMA)
Recruitment pool: Not stated Blood pressure : NR
Physical fitness : NR
Adverse events: NR
Health outcomes: NR
Others: Adherence to diet
Epstein et al 2001 3 Random allocation: yes, but unclear how randomization scheme was generated N randomized, completed: 67, 56 Description of intervention: Compares two groups that both received comprehensive, family-based behavior change program but differed in physical activity component (increased PA vs combined increased PA + decreased sedentary behavior). Goal of study is to assess sex differences. For both intervention groups, families met with individual therapist and separate parent and child group meetings on alternate weeks. Diet was Traffic Light Diet. Weight status: Ht * using a laboratory-constructed height board or a stadiometer Note: Primary goal was to detect interaction effect of gender with treatment group. Also, statistics were done on % overweight change, which is only depicted graphically.Did not assess Quality: Fair
Setting: Research clinic Blinding: Not mentioned Age range: 8–12 years ; 10.4 (1.2) yrs Increased PA : Reinforced for increasing moderate or greater PA (3 METS or greater). Goal was to increase activity in 30 min increments from baseline up to 180 min/week. Weight * using a medical balance beam scale Change in BMI (kg/m2) Financial deposits: $75 deposited by parents return contingent on completing 75% of sessions and attending 6 & 12 month f/u.
Location: Buffalo, NY Length of Intervention and f/u % male: 51.8% Combined increased PA + decreased sedentary activity: Same increased PA goals. % overweight Increase PA + decrease SB: Financial disclosures : NR
Int : 6 months % minority or non-white: not reportedAdditional goals: decrease 5 hr/wk of watching TV from baseline to meet goal of 15 hrs/wk.*Self-reported data were used when individuals were unable to attend assessments (7.3% of observations) and were adjusted.Girls: +1.00 kg/m2 (1.73)
F/u: 12 months Weight entry criteria: > 85th %ile BMI for age and sex and < 100% over the average BMI for age and sex Intensity level of intervention group vs. individual: Individual and group Time points : Baseline, 6 months, 12 monthsBoys: -1.76 kg/m2 (1.86)
Unit of allocation: Families Weight on entry: # sessions : 20 Behavioral: Increase PA alone:
Unit of analysis: targeted child and sibling % overweight: 60.2 % (18.9); (based on comparisons of the participant BMI to the 50th BMI %ile for age and sex over what time period : 6 months Diet: NRGirls: -0.27 (1.37)
Protection against contamination : unclear BMI 27.4 kg/m2 (3.6) length of sessions : 30 minutes PA: NRBoys: -0.65 (1.37)
Drop outs (%) 16% Recruitment pool: Children and parents living at home from families who participated in the Childhood Weight Control Program at the University of Buffalo and expressed interest. total contact time in minutes: 600 minutes Physiological: Group x sex interaction in rate of change in percentage overweight: F(2,102)=5.16, p=0.007, ES=0.25)
Primary care feasible/referable: Yes, referable Lipids: NR(Boys lost more weight than girls within each treatment group, especially in increased PA + decreased SB group)
glucose tolerance : NR
blood pressure : NR
physical fitness : NR
Adverse Events: NR
Health Outcomes: NR
Others: adherence to diet and PA, but data not reported by treatment subgroups
Gutin et al / Kang et al 2002 4, 5 Random allocation: Yes, but do not state method of generating randomization or concealment. N randomized, completed: 80, number completed is unclear-57 Description of intervention/ control conditions: Lifestyle education (LSE) only was compared to LSE + moderate and LSE + high intensity PA Weight status: Results for 8 months: NR Quality: Fair-to-poor
Setting: Research clinic Blinding: Not reported Age range: 13–16 yrs, mean not reported. LSE: classes that included principles of learning and behavior modification, information on nutrition and PA, psychosocial factors, problem solving, and coping skills.
  • Total body composition and % body fat by DEXA;
  • Visceral adipose tissue and subcutaneous abdominal adipose tissue by MRI
  • Body wt by electronic scale
  • Ht by stadiometer
Change in body fat: Financial deposits: No, but received financial compensation for attending PA training ($1/session) sessions and LSE ($5 per class)
Location: Georgia Length of Intervention and f/u: 8 months intervention period % male: 32.5% LSE + mod PA : same LSE plus exercise sessions. Individual goals based on VO2 and energy expenditure. Target HR calculated. Time points: Baseline, 4 mos, 8 mos LSE alone: -0.11 % (0.57) Financial disclosures: NR
Unit of allocation: individual adolescents % minority or non-white: 68.8% black LSE + high intensity PA: Same as above except target HR was higher. Overall goal calorie expenditure was the same as in moderate PA group. Behavioral: LSE + MIPT: -1.42 (0.84)
Unit of analysis: individuals Weight entry criteria: triceps skinfold thickness > 85th %ile for sex, ethnicity, and age. Intensity level of intervention group vs. individual : group Diet : yes, reported LSE + HIPT: -2.85 (1.25)
Protection against contamination: Tried to prevent by having PA group subjects have lifestyle class at different time than control group Weight on entry: # sessions: 16 for LSE group; 160 (5 sessions/wk) for LSE + PA groups PA : yes, reportedP=0.111
Drop outs (%): unclear, 29% BMI -NR; length of sessions : 1 hour for LSE, variable for physical training Physiological: Change in visceral adipose tissue:
% body fat: total contact time in minutes: unable to calculate Lipids: yes, reported LSE alone: -11.56 cm3 (10.47)
white boys-40.7%(2.2) over what time period: 8 months Glucose tolerance: yes, reported (fasting insulin and glucose levels) LSE + MIPT: -49.00 cm3 (15.73)
white girls-45.8%(1.5) Primary care feasible/referable: Yes, referable Blood pressure: yes, reported LSE + HIPT: -48.73 cm3 (15.71)
black boys-43.9%(2.3) Physical fitness: yes, reported (VO2 at HR of 170 bpm (mL*Kg-1*min-1))P=0.066
black girls-45.2% (0.9) Adverse Events: NRAlso present “effectiveness analyses” including only participants who attended > 40% of training sessions.
Recruitment pool: children who attended schools near research institute and advertisements in community and hospital newspapers Health outcomes: NR
Saelens et al 2002 6 Random allocation: Yes, but do not state how randomization scheme was generated. Randomization assignment concealed in opaque envelopes. N randomized, completed: 44, 39 completed treatment, 37 completed f/u assessment Description of intervention/ control conditions: Weight status: Weight using calibrated standard digital scale or beam scale; height using a stadiometer. Results at 7 months: No significant differences in problematic eating from baseline to post-treatment (4 mos) Quality: Good
Setting: Primary care Blinding: Not reported Age range: 12–16 yrs; 14.2 (1.2) yrs Exp: Healthy Habits (HH): Developmentally-tailored behavioral skills training program delivered via computer and telephone materials. Computer program assessment of PA and eating behavior. Individually tailored plan for increasing PA, decreasing SB, reducing dietary fat, overeating, snacking, and increasing fruit/vegetable intake discussed with pediatrician. Followed by phone calls by counselors with bachelor's degree in psychology or nutrition. Self-monitoring of food, beverage, intake and PA. Parent information sheets.Calculated BMI, BMI z scores, and % overweight BMI: Financial deposits: NR, but patients received $25 for post-treatment and $25 follow-up assessments
Location: southern California Length of Intervention and f/u: 4 mos, 7 mos (total 7 mos) % male: 59.1% Comp: Typical Care (TC ): Single non-tailored counseling session with a pediatrician covering motivation for wt-related change, health consequences, review of food guide pyramid and PA recommendations for adolescents, and encourage persistence with health behavior changes. Same pediatricians performed counseling for both HH and TC groups. Time points: baseline, 4 mos, 7 mos. Base-line7 mosFinancial disclosures: NR
Comp30.7(3.1)32.1(3.8)
Exp31.0(3.5)31.1(4.5)
Unit of allocation: individual patients % minority or non-white: 30% non-white ( 4.5% African American) Intensity level of intervention Behavioral: Percentage overweight:
Unit of analysis: individual patients Weight entry criteria: 20% to 100% above the median (50th %ile) for BMI for sex and age group vs. individual : individual Diet: yes, assessed Base-line7 mos
Comp62.3(17.4)66.4(20.1)
Exp62.0(20.5)59.6(24.6)
Protection against contamination - not described Weight on entry: BMI 30.7 (3.1) # sessions: 13 sessions PA: yes, assessedChange in baseline to follow-up BMI z-score between groups: F(1,42)=3.11, p < 0.09
Drop outs (%) 11% at 4 mos, 16% at 7 mos. Recruitment pool: two pediatric primary care clinics length of sessions: 10–20 min phone calls, not reported for pediatrician visit Physiologic: Decreased BMI z-score from baseline:
total contact time in minutes: around 200 minutes, Lipids: NRComp: 15.8%
over what time period : 4 months Glucose tolerance: NRExp: 55.6%
Primary care feasible/referable: yes, referable Blood pressure: NRχ2 (1) = 6.41, p < 0.22
Physical fitness: NR
Adverse Events: see health outcomes
Health outcomes: eating disorder psychopathology
Other outcomes: Behavior skills use;
Participant satisfaction
White 20037/Williamson unpublished data Random allocation: Yes, stratified by age and BMI but neither randomization procedure nor allocation concealment are described. N randomized, completed: 57, 50 Description of intervention: Randomized controlled trial of the Health Improvement Program for Teens (HIP-Teens) program, a primarily internet- and e-mail-based, family-based intervention study in African American adolescent girls comparing two treatment conditions: Weight status: 6 month results: Depression, self-esteem, eating disorder pathology, and satisfaction with life were measured at baseline but changes over time are not reported Quality: Good
Setting : Research clinic (internet-based) Blinding: not described Age range: Exp: a comprehensive behavioral intervention Primary measure: Change in % body fat measured by dual-energy x-ray absorptiometry (DEXA) Change % body fat - DEXA: Financial deposits: No, but received financial incentives from a computer purchase voucher ($700), free internet-services, gifts for attending sessions, and payment for assessments.
Location: Louisiana Length of Intervention and f/u: 6 months for this report (planned 2 years for full study) Eligible: 11–15 years Comp: an education only intervention (diet and broad physical activity). Secondary measures: Change in % body fat using bioelectrical impedance analysis; BMI Exp : -1.04 (2.00) Financial disclosures: NR
Unit of allocation: Child & parent Actual: 13.19 years (1.37)Full study period is 2 years but this publication reports results from first 6 months. Time points when weight was measured: Baseline, 6 months Comp: 0.38 (2.95)
Unit of analysis: Child & parent separately % male: 0% Intensity level of intervention Behavioral: (t=2.11, p=0.02)
Protection against contamination : Experimental and comparison group participants logged onto separate password-protected websites and could access only the website that was appropriate for their treatment assignment % minority or non-white: 100% African American group vs. individual : individual Diet- yes, reported (Multi-pass 24-hr recall of dietary intake; Food Frequency Questionnaire; Weight Loss Behavior Scale (WLBS), which measures concern about weight loss behaviors)) Change in % body fat-BIA:
Drop outs 12% Weight entry criteria: > 85th BMI %ile (using BMI-for-age growth charts from the National Center for Health Statistics) AND one obese biological parent (BMI>27 and willing to participate in study) # sessions, over what time period: weekly website logins over 6 months; approximately 600 website logins for experimental group and 200 logins for comparison group. PA- yes, reported (WLBS) Exp : -0.05 (1.20)
Weight on entry: length of sessions: NR Physiological: Comp : 0.75 (1.49)
BMI: 36.34 kg/m2 (7.89); total contact time (min): NR Lipids/ lipoproteins: NR(t=2.23, p=0.01)
DEXA %fat: 45.84 (7.4); Primary care feasible/referable? Yes, feasible or referable Glucose tolerance: NR Change in BMI (kg/m2):
BIA-fat: 42.41 (6.52) blood pressure: NR Exp : -0.24 (1.38)
Recruitment pool: Community physical fitness: NR Comp : 0.71 (1.19)
Adverse Events: See health outcomes(t=2.77, p < 0.01)
Health outcomes: Depression, self-esteem, eating disorder pathology, and satisfaction with life were measured at baseline but changes over time are not reported Change in wt (kg):
Others: Exp : 0.55 (3.26)
-Child dietary self-efficacy Comp : 2.40 (2.86)
-adherence measured by # website “hits”, completing weekly quizzes(t=2.28, p=0.03)
-Weight loss behavior scale (measuring concern for wt loss behaviors)
-computer anxiety
-Parent measures (multiple measures)

References for Appendix L

1.
Berkowitz RI, Wadden TA, Tershakovec AM, Cronquist JL. Behavior therapy and sibutramine for the treatment of adolescent obesity: a randomized controlled trial. JAMA. 2003;289(14):1805–1812. [PubMed: 12684359]
2.
Ebbeling CB, Leidig MM, Sinclair KB, Hangen JP, Ludwig DS. A reduced-glycemic load diet in the treatment of adolescent obesity. Archives of Pediatrics & Adolescent Medicine. 2003;157(8):773–779. [PubMed: 12912783]
3.
Epstein LH, Paluch RA, Raynor HA. Sex differences in obese children and siblings in family-based obesity treatment. Obesity Research. 2001;9(12):746–753. [PubMed: 11743058]
4.
Gutin B, Barbeau P, Owens S, Lemmon CR, Bauman M, Allison J. et al. Effects of exercise intensity on cardiovascular fitness, total body composition, and visceral adiposity of obese adolescents. American Journal of Clinical Nutrition. 2002;75(5):818–826. [PubMed: 11976154]
5.
Kang HS, Gutin B, Barbeau P, Owens S, Lemmon CR, Allison J. et al. Physical training improves insulin resistance syndrome markers in obese adolescents. Medicine & Science in Sports & Exercise. 2002;34(12):1920–1927. [PubMed: 12471297]
6.
Saelens BE, Sallis JF, Wilfley DE, Patrick K, Cella JA, Buchta R. Behavioral weight control for overweight adolescents initiated in primary care. Obesity Research. 2002;10(1):22–32. [PubMed: 11786598]
7.
White MA. Mediators of Weight Loss in an Internet-Based Intervention for African-American Adolescent Girls. Louisiana State University, 2003.
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