Developing a complex intervention for diet and activity behaviour change in obese pregnant women (the UPBEAT trial); assessment of behavioural change and process evaluation in a pilot randomised controlled trial

Abstract

BackgroundComplex interventions in obese pregnant women should be theoretically based, feasible and shown to demonstrate anticipated behavioural change prior to inception of large randomised controlled trials (RCTs). The aim was to determine if a) a complex intervention in obese pregnant women leads to anticipated changes in diet and physical activity behaviours, and b) to refine the intervention protocol through process evaluation of intervention fidelity.MethodsWe undertook a pilot RCT of a complex intervention in obese pregnant women, comparing routine antenatal care with an intervention to reduce dietary glycaemic load and saturated fat intake, and increase physical activity. Subjects included 183 obese pregnant women (mean BMI 36.3 kg/m2).Diet was assessed by repeated triple pass 24-hour dietary recall and physical activity by accelerometry and questionnaire, at 16+0 to 18+6 and at 27+0 to 28+6 weeks’ gestation in women in control and intervention arms. Attitudes to behaviour change and quality of life were assessed and a process evaluation undertaken. The full RCT protocol was undertaken to assess feasibility.ResultsCompared to women in the control arm, women in the intervention arm had a significant reduction in dietary glycaemic load (33 points, 95% CI −47 to −20), (p < 0.001) and saturated fat intake (−1.6% energy, 95% CI −2.8 to −0. 3) at 28 weeks’ gestation. Objectively measured physical activity did not change. Physical discomfort and sustained barriers to physical activity were common at 28 weeks’ gestation. Process evaluation identified barriers to recruitment, group attendance and compliance, leading to modification of intervention delivery.ConclusionsThis pilot trial of a complex intervention in obese pregnant women suggests greater potential for change in dietary intake than for change in physical activity, and through process evaluation illustrates the considerable advantage of performing an exploratory trial of a complex intervention in obese pregnant women before undertaking a large RCT.Trial registrationTrial Registration Number: ISRCTN89971375

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“…Studies evaluating group-based interventions in other clinical settings have also reported positive feedback on this format of intervention delivery. 549,557,560 Therefore, although the group format was a reason for non-participation for some patients, those who attended the course enjoyed the format and engagement with other patients. This highlights an issue affecting many trials: a potentially biased sample because of the self-selection of participants with a preference for the intervention.…”

“…The logistics of scheduling group-based interventions is challenging, as many patients have limited availablity owing to other commitments. 538,549 Increasing flexibility in the scheduling of group-based interventions can be challenging, particularly within the financial constraints of a trial, but having the flexibility to run multiple courses is an important factor to consider when costing a trial.…”

“…548 A pilot study of a complex intervention for diet and activity behaviour change in obese pregnant women found that increased flexibility of the timing of sessions was necessary to improve attendance and some activities, such as goal-setting, were better conducted individually rather than in a group setting to minimise perceptions of being judged. 549 Therefore, the aims of this study were twofold: (1) to evaluate the feasibility of conducting a RCT to assess the clinical effectiveness and cost-effectiveness of a group-based pain self-management course for patients undergoing THR, and (2) to assess the acceptability of the intervention. Specific objectives were to assess the feasibility of trial design and procedures, ascertain recruitment and retention rates, identify barriers to participation, develop resource-use data collection methods, assess questionnaire completion rates, and evaluate uptake and patient satisfaction with the course.…”

Association between Physical Activity in Obese Pregnant Women and Pregnancy Outcomes: The UPBEAT Pilot Study

“…ISRCTN89971375). A pilot RCT in 183 women to determine if the intervention led to changes in physical activity and diet was completed in 2011 [32]. Research Ethics Committee approval was obtained for the trial (UK Integrated Research Application System reference 09/H08-2/5), and all participants provided written informed consent to participate in the trial.…”

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