Randomised Controlled Feasibility Trial of an Evidence-Informed Behavioural Intervention for Obese Adults with Additional Risk Factors

Abstract

BackgroundInterventions for dietary and physical activity changes in obese adults may be less effective for participants with additional obesity-related risk factors and co-morbidities than for otherwise healthy individuals. This study aimed to test the feasibility and acceptability of the recruitment, allocation, measurement, retention and intervention procedures of a randomised controlled trial of an intervention to improve physical activity and dietary practices amongst obese adults with additional obesity related risk factors.MethodPilot single centre open-labelled outcome assessor-blinded randomised controlled trial of obese (Body Mass Index (BMI)≥30 kg/m2) adults (age≥18 y) with obesity related co-morbidities such as type 2 diabetes, impaired glucose tolerance or hypertension. Participants were randomly allocated to a manual-based group intervention or a leaflet control condition in accordance to a 2∶1 allocation ratio. Primary outcome was acceptability and feasibility of trial procedures, secondary outcomes included measures of body composition, physical activity, food intake and psychological process measures.ResultsOut of 806 potentially eligible individuals identified through list searches in two primary care general medical practices N = 81 participants (63% female; mean-age = 56.56(11.44); mean-BMI = 36.73(6.06)) with 2.35(1.47) co-morbidities were randomised. Scottish Index of Multiple Deprivation (SIMD) was the only significant predictor of providing consent to take part in the study (higher chances of consent for invitees with lower levels of deprivation). Participant flowcharts, qualitative and quantitative feedback suggested good acceptance and feasibility of intervention procedures but 34.6% of randomised participants were lost to follow-up due to overly high measurement burden and sub-optimal retention procedures. Participants in the intervention group showed positive trends for most psychological, behavioural and body composition outcomes.ConclusionsThe intervention procedures were found to be acceptable and feasible. Attrition rates were unacceptably high and areas for improvements of trial procedures were identified.Trial RegistrationControlled-Trials.com ISRCTN90101501

What are the most effective techniques in changing obese individuals’ physical activity self-efficacy and behaviour: a systematic review and meta-analysis

“…Forward and backward searches identified another 13 eligible publications (see Figure 1). A total of 61 comparisons (58 publications) were included for the self-efficacy analyses [18-75] and 42 comparisons (39 publications either linked to or the same as the original 58 publications) were included for the physical activity behaviour analyses [18,19,24-26,28,35,36,38,40-43],[45,47-50,52,54,56-59,61,63,65-68],[70,71,73,75-81]. …”

“… a Data on age, exact BMI, gender and ethnicity was not provided by all studies. b This is the range for both the self-efficacy and physical activity studies. c This data is for the statistical analyses conducted, some of the studies were RCT’s but were analysed as pre-post studies. d One study measured perceived behavioural control, not self-efficacy [68]. …”

A randomised controlled trial and cost-effectiveness evaluation of ‘booster’ interventions to sustain increases in physical activity in middle-aged adults in deprived urban neighbourhoods

“…105 High levels of deprivation are known to predict poor consent rates in trials evaluating behavioural interventions for sedentary people. 106,107 It may be particularly difficult to recruit healthy participants in deprived communities for an intervention that may have significant costs to participants, including both the costs of behaviour change and the time and travel costs of attending for the intervention as well as recruitment, baseline data collection and follow-up. We were also recruiting participants from an age group (40-65 years) in which many people have both work and family responsibilities, which may make it particularly likely that perceived costs will outweigh the perceived benefits of participation.…”

Modifying Alcohol Consumption to Reduce Obesity (MACRO): development and feasibility trial of a complex community-based intervention for men

“…11 Men are under-represented in weight loss interventions 12 and attrition is high in weight loss studies. 13,14 Previous research has identified many features of an intervention that could make it attractive to potential male participants. Convenience and compatibility with a busy life are important, [15][16][17] as is the use of community settings for intervention delivery.…”