Contemporary Clinical Trials Communications (Dec 2016)
Design of a lifestyle intervention to slow menopause-related progression of intra-abdominal adipose tissue in women: The Women in the Southside Health and Fitness (WISHFIT) study
Abstract
Background: Changes in reproductive hormones during menopause are associated with accumulation of intra-abdominal adipose tissue (IAAT), a subclinical indicator of cardiometabolic disease risk. Independent of reproductive hormones, unhealthy lifestyle contributes to IAAT gain. The Women in the Southside Health and Fitness (WISHFIT) Study aims to develop a lifestyle approach to slowing IAAT accumulation as women begin the menopausal transition. Methods: The primary aim is to develop and conduct a proof-of-concept test of a multi-component, multi-level behavioral intervention targeting jointly physical activity, diet, and psychological well-being. Participants attend group sessions over 2 years to experiment with healthy living through both experiential and didactic learning, cultivate a health network, and draw on community resources to sustain change. The primary endpoint is 2-year IAAT progression, assessed using computerized tomography. Behavioral targets of treatment and secondary endpoints will be evaluated at 6, 12, 18 and 24 months. Change in social networks and community support will be assessed at 2 years. Results: WISHFIT recruited 71 pre- and peri-menopausal Caucasian and African American women (mean ± SD age = 47.6 ± 3.4 yrs; BMI = 33.6 ± 7.3 kg/m2; 52% African American). Baseline IAAT was 2104.1 ± 1201.3 cm3. IAAT, physical activity, BMI, and self-reported family income and resilience differed by ethnicity at baseline. Conclusions: WISHFIT is a multi-component, multi-level intervention aimed at producing a sustained improvement in physical activity, diet, and psychological well-being early in the menopausal transition to slow menopause-related accumulation of IAAT. It provides a model for the process of developing a behavioral treatment to manage a chronic disease.
Keywords