A feasibility randomised controlled trial of a weight management programme for women living with obesity and infertility

Condition studied

obesity, infertility

Investigational medicinal product(s)

Every trial of Tirzepatide across our registers →

Eligibility

Primary endpoint

Recruitment rate: calculated from the proportion of randomised participants from those screened for eligibility. In addition, we will calculate the number who pass the eligibility as a subset against those randomised., Retention rate: measured by the percentage of participants who complete the 3- and 6 month study visit., Medication adherence in those allocated to receive tirzepatide: we have defined adherence to Tirzepatide as participants taking 75% of the study medication during the trial., Engagement with digital platform: collected via closed and open ended questions at study visits in both arms. Engagement with monthly health coaching sessions will be considered acceptable if 4 out of 6 sessions are attended., Acceptability of the pharmacotherapy component and the behaviour change component delivered through a digital platform: assessed through semi structured qualitative interviews a subset of participants in both arms (10 in each arm).

Endpoint detail

Anthropometric changes (intervention vs control): - change in body weight (% change, change in kg) from baseline to 3/6/9 months follow up - participants who achieve ≥5% body weight reduction from baseline to 6 month follow up - women achieving a BMI making them eligible for fertility treatments (n,%) - treatment response by BMI (BMI<35, BMI 35-40kg/m2) from baseline to 6 months follow up - change in waist circumference (cm) from baseline to 6 months follow up, Reproductive health (intervention vs control): menstrual cycle regularity, pregnancy rate at 9 month follow up. Pregnancy will be assessed as an exploratory descriptive outcome and will not be used for comparative assessment between treatment groups due to the differing contraception requirements between groups., Metabolic changes (intervention vs control): systolic and diastolic blood pressure, glycaemic status (HbA1c, glucose, insulin, HOMA-IR), lipid profile (cholesterol, triglycerides, HDL, LDL) assessed at baseline and 6 months follow up, Behaviour change (intervention vs control): dietary intake assessed using Foodbook24, eating behaviour assessed using a validated eating behaviour questionnaire, physical activity via IPAQ-SF at baseline and 3/6/9 months follow up, Mental health (anxiety, depression, stress) (intervention vs control): assessed by PHQ-9, GAD-7, PSS assessed at baseline and 3/6/9 months follow up, Quality of life (intervention vs control): assessed by EQ-5D-5 at baseline and 3/6/9 months follow up, Access to fertility treatments (intervention vs control): outcomes will be recorded if women meet criteria for public fertility treatment, or if they opt to go private