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Wyke S, Hunt K, Gray CM, et al. Football Fans in Training (FFIT): a randomised controlled trial of a gender-sensitised weight loss and healthy living programme for men – end of study report. Southampton (UK): NIHR Journals Library; 2015 Jan. (Public Health Research, No. 3.2.)

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Football Fans in Training (FFIT): a randomised controlled trial of a gender-sensitised weight loss and healthy living programme for men – end of study report.

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Chapter 3Results: the randomised controlled trial

Participant flow

Figure 2 shows participant flow through the trial. Of the 1231 men registering an interest during the recruitment period, 483 were excluded from the trial (101 decided against participation, 76 had a BMI < 28 kg/m2, 306 were allocated to the non-trial delivery of FFIT). Three hundred and seventy-four were randomly allocated to the intervention group and 374 to the comparison group. One comparison group participant subsequently withdrew and requested we destroy his data.

FIGURE 2. Flow of participants through the FFIT RCT.

FIGURE 2

Flow of participants through the FFIT RCT. a, After randomisation, one participant requested to have all of his data destroyed. Reprinted with permission from Elsevier (The Lancet, 2014, 383, 1211–21).

Recruitment

As described below (see Baseline data), formal recruitment commenced on 2 June 2011 (although preparations for recruitment had begun in anticipation of receiving the grant award) and continued until the week before the baseline measurements in each club, between 11 August 2011 and 20 September 2011. Figure 3 shows that recruitment started slowly, probably because in Scotland the 2010/11 season had closed and the 2011/12 season had yet to begin. As the clubs and media coverage geared up for the start of the season, and we were able to recruit men at games, recruitment speeded up so that we exceeded our target of 1110 men.

FIGURE 3. Recruitment to the FFIT study from May to September 2011.

FIGURE 3

Recruitment to the FFIT study from May to September 2011.

Baseline data

Table 6 shows baseline characteristics of participants (n = 747), including total self-reported MET-minutes per week. FFIT attracted men from across the socioeconomic spectrum, but few from ethnic minority groups.

TABLE 6. Baseline characteristics of participants allocated to the FFIT programme immediately (FFIT) or in 12 months (comparison).

TABLE 6

Baseline characteristics of participants allocated to the FFIT programme immediately (FFIT) or in 12 months (comparison). Data are number (%), mean (SD) or median (interquartile range)

Table 7 shows baseline levels of self-reported physical activity in relation to whether activity was vigorous, moderate or walking (reported in MET-minutes/week) or time spent sitting on a week day in the last 7 days.

TABLE 7. Baseline self-reported physical activity from the IPAQ at baseline.

TABLE 7

Baseline self-reported physical activity from the IPAQ at baseline. Data are median (interquartile range)

Numbers analysed

After randomisation, one participant allocated to the comparison group withdrew and requested that all of his data be destroyed. This left 374 participants in the intervention group and 373 in the comparison group. Retention was high, although it varied between intervention and comparison groups (see Figure 2). At 12 weeks, measurements were obtained for 91% of participants: 330 out of 374 (88%) in the intervention group and 347 out of 373 (93%) in the comparison group. At 12 months, measurements were obtained for 92% of participants: 333 out of 373 (89%) in the intervention group and 355 out of 373 (95%) in the comparison group. All analyses were conducted as intention to treat on randomised participants with all available data.

Outcomes

Primary outcome: weight at 12 months

At 12 months, mean weight loss among men in the intervention group was 5.56 kg (95% CI 4.70 kg to 6.43 kg) and 0.58 kg (95% CI 0.04 kg to 1.12 kg) in the comparison group (Table 8).

TABLE 8

TABLE 8

Change in weight at 12 months complete case analysis (mean, 95% CI)

The mean difference in weight loss between groups, adjusted for baseline weight and club, was 4.94 kg (95% CI 3.95 kg to 5.94 kg) and the mean difference in percentage weight loss at 12 months, similarly adjusted, was 4.36% (Table 9).

TABLE 9

TABLE 9

Difference between groups in change in weight at 12 months (linear regression models) (mean, 95% CI)

Sensitivity analyses on primary outcome: change in weight at 12 months

The sensitivity analyses gave similar results to the main analysis (Table 10). Using multiple imputation, assuming data were missing at random, to account for missing data the mean difference in weight loss between groups adjusted for baseline weight and club was 4.93 kg (95% CI 3.92 kg to 5.94 kg). Adding club as a random effect to account for possible clustering, the mean difference in weight loss between groups adjusted for baseline weight was 4.94 kg (95% CI 3.83 kg to 6.04 kg). Using repeated measures to make use of weight loss data from both 12 weeks and 12 months found that the mean difference in weight loss between groups at 12 months, adjusted for baseline weight and club, was 5.28 kg (95% CI 4.62 kg to 5.94 kg) (see Table 10).

TABLE 10

TABLE 10

Sensitivity analyses: difference between groups in change in weight (kg) at 12 months (linear regression models) (mean, 95% CI)

As shown in Figure 4, participants lost most weight over the period that coincided with the 12 weekly sessions delivered in the clubs.

FIGURE 4. Mean weight (kg, 95% CI) in participants allocated to the FFIT weight loss programme or waiting list comparison group 12 weeks and 12 months after baseline measurement.

FIGURE 4

Mean weight (kg, 95% CI) in participants allocated to the FFIT weight loss programme or waiting list comparison group 12 weeks and 12 months after baseline measurement. Note that the y-axis (weight) does not start at zero. Reprinted with permission from (more...)

Subgroup analyses on primary outcome

In order to investigate potential differential effects on the primary outcome by subgroup, we investigated associations between pre-specified subgroups (see Chapter 2, Statistical methods) and weight loss at 12 months. Table 11 shows which variables were significantly associated with weight loss in univariate analyses.

TABLE 11

TABLE 11

Univariate associations between various characteristics of FFIT participants and weight loss at 12 months

Table 12 demonstrates that in multiple regression analyses including only those variables which had shown significant association with weight loss in univariate analysis together with weight at baseline and treatment group, the only significant associations were weight at baseline and treatment group. That is, the pre-specified subgroup analyses found no significant additional predictors of primary outcome and the intervention effect did not vary significantly by age, marital status, deprivation of area participants’ residence, location of measurement (stadium vs. home), orientation to masculine norms, affiliation to football, whether or not attended a formal weight management programme in last 3 months, smoking, housing tenure, education, ethnicity, employment status, joint pain, injuries and number of long-standing illnesses.

TABLE 12

TABLE 12

Multivariate analyses: effect of various characteristics of FFIT participants, treatment group and weight at baseline on weight loss at 12 months

Secondary outcomes

More men in the intervention group (39.04%, 130/333) than the comparison group (11.27%, 40/355) achieved at least 5% weight loss at 12 months (RR 3.47, 95% CI 2.51 to 4.78) and more had a BMI below 30 kg/m2 (Table 13).

TABLE 13

TABLE 13

Changes from baseline in objectively measured categorical outcomes at 12 weeks and 12 months in FFIT participants and waiting list comparison group and relative risks of achieving target weight loss and being classified as not obese

Table 14 shows changes in other secondary outcomes at 12 weeks and 12 months, before and after adjusting for baseline measure and clubs. These analyses show similarly positive results.

TABLE 14

TABLE 14

Changes in objectively measured continuous outcomes, self-reported outcomes and self-reported psychological health outcomes

In relation to objectively measured secondary outcomes, adjusting for baseline measure and club, the mean difference in reduction at 12 months in waist circumference was 5.12 cm (95% CI 4.27 to 5.97 cm) and in BMI was 1.56 kg/m2 (95% CI 1.29 to 1.82 kg/m2). Differences in changes in all other objectively measured secondary outcomes, including weight loss at 12 weeks, % body fat at 12 weeks and 12 months, and systolic and diastolic blood pressure at 12 weeks and 12 months were also all in favour of the intervention and highly statistically significant (p < 0.0001, except for systolic BP at 12 months where p = 0.017) (see Table 14). There was clear attenuation of effect between the end of 12-week programme and 12-month measurements.

In relation to eating and drinking alcohol, Table 14 demonstrates that reductions in the fatty food and sugary food scores were greater for participants in the FFIT programme than in the comparison group at 12 weeks, and these differences remained highly significant at 12 months (p < 0.0001) although, again, there was considerable attenuation of the effects between 12 weeks and 12 months. Similarly, positive changes in reported eating patterns were seen for the fruit and vegetable score; the differences in the increase seen in fruit and vegetable consumption were highly significant (p < 0.0001) at 12 weeks and 12 months, in favour of the intervention (see Table 14). They also reported drinking less units of alcohol per week; the mean difference in units of alcohol reported being drunk between groups, adjusted for baseline units and club, was 4.47 (95% CI –6.09 to –2.86) at 12 weeks and 2.59 (95% CI –4.21 to –0.97) at 12 months (see Table 14).

In relation to changes in self-reported QoL and mental health, Table 14 illustrates that FFIT also resulted in greater improvements in self-esteem and positive affect at 12 weeks and 12 months in the intervention than the comparison groups, and greater reductions in negative affect at 12 weeks and 12 months. Similarly, there were greater improvements in scores on physical aspects of QoL as measured by the SF-12 at 12 weeks and 12 months, but the greater improvements in mental HRQoL in the intervention group at 12 weeks were no longer significantly different from the comparison group at 12 months (see Table 14). As with all other outcomes, there was attenuation of the differences between the two groups between 12 weeks and 12 months.

In relation to self-reported physical activity, as the changes in MET-minutes were highly positively skewed, the standard linear-mixed models were not valid and so linear modelling on natural log-transformed was implemented for total MET-minutes/week. Table 14 illustrates that the increase in total MET-minutes per week was greater in the intervention group than the comparison group with an adjusted RGM at 12 months of 1.49 (IQR 1.11–1.99) for total MET-minutes, in other words roughly 50% higher in the intervention.

To further investigate changes in self-reported physical activity in addition to log-transformations, we applied a repeated measures analysis using data from 12 weeks and 12 months in relation to total activity but also whether activity was vigorous, moderate or walking (reported in MET-minutes/week) and time spent sitting on a week day in the last 7 days.

Table 15 illustrates that the repeated measures analysis gave very similar results to the standard analysis in relation to increase in total MET-minutes per week. The results also indicated that when total activity is subdivided into the constituent elements, the improvement in physical activity was greatest for vigorous (RGM 4.63, 95% CI 2.64 to 8.12), followed by moderate (RGM 2.10, 95% CI 1.22 to 3.62) and then walking (RGM 1.31, 95% CI 0.91 to 1.89) (see Table 15). It is also clear that there was considerable attenuation in the effects between 12 weeks and 12 months, although there were still highly significant differences between the groups at 12 months for vigorous and moderate physical activity at 12 months, though not in walking.

TABLE 15

TABLE 15

Changes from baseline in physical activity measured by the self-reported IPAQ at 12 weeks and 12 months and differences between participants allocated to the FFIT weight loss programme or waiting list comparison group

There was some evidence of a reduction in time spent sitting in the intervention group, especially at 12 weeks (RGM 0.85, 95% CI 0.78 to 0.93) but these effects were modest; at 12 weeks self-reported sitting time was 15% lower in the intervention group relative to the comparison group (p = 0.0005). However, at 12 months there was no statistically significant difference in sitting time (see Table 15 between groups).

Adverse events

Eight serious adverse events were reported: five in the intervention and three in the comparison group. Two appeared to be, or were reported as, related to participation in FFIT: one participant ruptured an Achilles tendon while playing football and the other was told by his doctor that intermittent abdominal pains from gall stones could have been aggravated or caused by weight or dietary changes.

A total of 211 adverse events were reported: 107 events reported by 96 men in the intervention and 104 events in the comparison group reported by 92 men. Ten appeared to be, or were reported as, related to participation in FFIT: five occurred at FFIT sessions, three elsewhere (two when running; one playing football) and it was unclear where the other two occurred. Seven of the men reported leg injuries (often ligament damage), one a dislocated shoulder, one leg and shoulder injuries and one a head collision (with another participant at a FFIT session). Another 11 adverse events could have been related to participation in FFIT, but the research team were unable to contact the men to confirm this. Of these, five occurred playing football and two when running; it was not clear where the remainder had happened. Six involved leg injuries and the others were reported as neck, leg, groin, hand and collar bone injuries.

Copyright © Queen’s Printer and Controller of HMSO 2015. This work was produced by Wyke et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

Included under terms of UK Non-commercial Government License.

Bookshelf ID: NBK274007

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