A pilot trial to test the feasibility of delivering a weight loss intervention for improving fertility in women with a BMI over 30kg/m2 and their partners.
Creators: name: Hunter, Emma
Publisher: name: Open Science Framework
Year: 2022
Subjects: subject: Medicine and Health Sciences
subject: Social and Behavioral Sciences
subject: Weight loss for fertility study

description: Background: Increased weight has been associated with fertility problems in both women and men. In recent years there has been a rise in the numbers of overweight and obese patients seen within fertility clinic settings. Weight loss interventions including reduced calorie diets and physical activity have been found to help women and men reduce their weight and increase their chances of conception. Research suggests a couple-based weight loss intervention may produce better results compared to interventions focusing on individuals. However, no couple-based weight loss interventions have been used in the UK, therefore, it is unclear how effective this might be and whether it would result in better outcomes. This study will evaluate the feasibility of delivering a weight loss intervention, involving a commercial weight loss programme (WLP), to couples experiencing fertility difficulties where the female partner seeking pregnancy has a BMI &gt; 30. Design: The present study is a single centre, randomised controlled trial. A total of 54 couples will be randomly assigned to one of three groups 1) Both partners receive vouchers to attend a WLP together 2) The woman seeking pregnancy receives vouchers to attend a WLP on her own 3) A waitlist control group who will receive vouchers to attend the WLP at the end of the 24 week intervention period. The primary aim of the study is to investigate the feasibility of delivering a WLP to women with a BMI &gt; 30 and their partners who are struggling to conceive. Secondary aims include: the feasibility of recruiting couples experiencing fertility difficulties to a WLP, the feasibility and acceptability of a weight loss intervention involving a community based WLP for women and their partners, the feasibility of using physical activity trackers to objectively measure physical activity, retention rates and potential intervention effects on weight loss and menstrual cycle regularity. Methods: The primary outcome of this pilot trial is the feasibility of delivering a couple-based weight loss intervention to improve fertility in women with a BMI &gt;30 and their partners, assessed by monthly recruitment rates into the trial, attendance rate at the weight loss group sessions, retention rates over three months, missing data rates on sensor-based assessment and mechanisms of change in each arm of the trial. Physical activity will be assessed with wearable activity trackers. Participants will complete questionnaires at the start of the study and again at three months to report physical activity, mechanisms of change for eating and physical activity such as attitude, perceived behavioural control and intentions, levels of social support for eating and activity, relationship quality and wellbeing. Similarly, interviews will be held at the start to further explore questionnaire answers and end of the study to gain insight to participants’ thoughts, feelings and experiences during the trial in order to assess acceptability of the intervention and trial procedures. Analysis: The research team will use descriptive statistics to describe study recruitment and retention rates, intervention uptake and attendance and rate and predictors for missing data in assessments. They will conduct quantitative comparison analyses on change in weight and activity to obtain estimates and precision to inform a future full trial. Additionally, thematic analysis will be undertaken to code the qualitative interview data to describe the acceptability and experience of study procedures. Discussion: The research team expects it will be feasible to deliver a weight loss intervention to couples experiencing fertility difficulties to expedite weight loss. Furthermore, we expect that the couple-based intervention group will achieve better outcomes regarding adherence to the WLP programme and greater weight loss compared to the women only group and the waitlist control group.