Predictors of weight change during the menopausal transition using a precision medicine platform: Defining a phenotype

A comprehensive assessment of individual characteristics associated with adverse weight gain during the menopausal transition and how they contribute to overall cardiovascular health may provide necessary insights to inform educational efforts and strategies aimed at reducing the burden of CVD in women. We propose to leverage the AHA/Verily Research Goes Red registry of women and Precision Medicine Platform to conduct a pilot 1y longitudinal study consisting of 1) deep phenotyping in 300 women ages 45-55 y, with comparison among those who underwent the menopausal transition over the course of the study vs those who remained pre- or post-menopausal; and 2) correlates of weight gain among these 300 women, who will provide information on food intake, meal timing, meal frequency, reproductive history, timing of physical activity in relation to meals and sleep patterns. Specific Aims of the pilot project are: 1a) to conduct deep phenotyping and examine changes from baseline to 1y in markers associated with adverse weight gain (primary outcome) and CVD risk: waist circumference, body composition, glucose, lipids, insulin resistance, inflammation (C-reactive protein, interleukin-6), and adipokines (leptin and adiponectin); 1b) to compare changes in the biomarkers listed in Aim 1a among women undergoing the menopausal transition vs those who remained pre- or post-menopausal; and 2) to examine correlates of weight gain during the menopausal transition including meal timing, meal frequency, reproductive history, physical activity, perceived stress, and sleep patterns. Potential correlates will be collected via questionnaire at baseline and 1y. Public Health Relevance: The menopausal transition period may represent a critical window for improving cardiovascular risk among women. Results of this pilot study will help define the biomarker phenotype accompanying weight gain during the menopausal transition. This study will examine both cross-sectional and longitudinal associations between weight gain and multiple clinical indicators of CVD risk and investigate how changes in these markers over a 1y period may alter risk. Further, this study will be the first of its kind to demonstrate the feasibility of collecting data from the Research Goes Red registry in a decentralized way, with concentration on a topic (weight) that was indicated as a top healthy priority for women who enrolled in the registry.