The ’40-Something’ Study: Preventing weight gain prior to menopause

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BACKGROUND AND AIMS Middle age (45-54y), when most women experience menopause, is a particularly high risk stage for weight gain in women, and more than half the women in this age group are overweight or obese. Post-menopause is characterised by the absence of oestrogen resulting in abdominal deposition of body fat and subsequent development or exacerbation of metabolic syndrome. An estimated 48% of coronary events in women are attributable to metabolic syndrome, and risk of cardiovascular disease significantly increases after menopause. There is some evidence that intervention can prevent or minimise the body composition changes leading to post-menopausal obesity, making the years immediately prior to menopause a key stage for intervention. Despite the increased health risks associated with menopausal weight gain, no Australian interventions have been developed for this target group. A potential model for intervention exists within the Enhanced Primary Care (EPC) scheme of Medicare (funding of 5 Allied Health visits for those referred by a GP with chronic and complex problems). This model could be extended to the target group of women in the years immediately prior to menopause. The aim of this randomised control trial (the 40-Something Study) is to pilot test the feasibility of applying this model to the prevention of weight gain in non-obese women aged 44-50. Given the RCT will be a pilot of what will hopefully be a wider intervention, it will particularly assess the feasibility of recruiting into the study, ability to retain participants and will test the intervention and information only materials. RESEARCH PLAN The study has been designed to adhere to the CONSORT guidelines. An RCT design is being used to test the ability of a 12 month intensive intervention (four Dietitian appointments and one Exercise Physiologist appointment using motivational interviewing to advise on dietary and physical activity strategies) to prevent weight gain, in comparison to the provision of written information. Women were invited to participate if they were between 44 and 50y, still menstruating, BMI 18.5- 29.9 and able to attend appointments in Newcastle, NSW. Those in the healthy weight range (18.5-24.9kg/m2) at baseline will be given the goal of maintaining weight within 1kg, and provided with weight maintenance advice, (8300kJ/day, and at least 150 mins/week of PA). Women in the overweight range (25-29.9 kg/m2) at baseline will be advised to lose at least 7% of body weight, (by following a 6300kJ/day regime and 250 mins/wk of PA) before being given weight maintenance advice. After baseline data was collected the women were randomly allocated to intervention or control groups. All researchers except the Dietitian conducting the appointments with the intervention group will remain blind to the allocation condition. The primary outcome measures are weight and waist circumference, with secondary measures of biomarkers of metabolic syndrome. Baseline data has been collected on anthropometry, biomarkers of metabolic syndrome, and behaviours influencing weight gain including dietary intake, physical activity and dietary restraint, in addition to health and demographic data. The data will be collected again at 12 months after the intervention commenced. Compliance to the interventions in terms of dietary intake and PA is being measured 3 months after commencing the intervention. The study involves a comparison of a baseline measurement to a single follow-up measure to assess the success of the intervention (baseline to 12 months). Paired t-tests will be used to determine if there is a significant change in weight for each group with sub-analyses for those normal weight and overweight at baseline. Repeated measures analysis of covariance will be used to examine whether the groups (control and intervention) differ significantly on the amount of weight change between baseline and follow up. The project will be monitored by a Management Committee (meeting at least monthly) to oversee project implementation.