Arriba por la Vida Estudio (AVE): Study protocol for a standing intervention targeting postmenopausal Latinas

Background: Postmenopausal Latinas are a growing population group in the US who are at high risk for cardiovascular disease. Epidemiological studies have shown that excessive sitting is related to cardiovascular disease risk. Older women sit for prolonged periods and most individuals do not meet physical activity guidelines. Reducing sitting through increased standing may improve cardiovascular risk. More research is needed on how to intervene to increase standing in older Latinas. Objective: To describe the protocol for a randomized controlled trial to increase standing in postmenopausal Latinas: the Arriba por la Vida Estudio (AVE). Design/methods: Postmenopausal Latinas will be randomized to one of two study arms: an increase standing intervention or a heart healthy attention-comparison condition. A total of 250 overweight postmenopausal Latinas will be recruited and followed for 12 weeks. AVE is based on various models of behavior change including strategies such as self-monitoring, goal setting, and habit formation. Participants will receive three in-personhealth-counseling sessions (including one in-home visit) and five follow-up telephone calls using motivational interviewing techniques. Those in the attention-comparison condition will receive an equal number of contacts as the standing intervention with topics focused on healthy aging. The primary outcome is objectively-measured sitting time over three months measured via thigh-worn inclinometers and secondary outcomes include blood pressure, physical functioning and glucoregulatory and lipid biomarkers. Conclusions: The findings from this study will provide valuable information about effective approaches to increase standing time in postmenopausal Latinas and its impact on cardiovascular disease risk. Trial registration: This study is registered at clincialtrials.gov Identifier: NCT02905929