NCT02905929

Trial to Reduce Sitting Time in Postmenopausal Latina Women at Increased Risk for Heart Disease

Randomized Control Trial to Reduce Sitting Time in Postmenopausal Latina Women at Increased Risk for Heart Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 254 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: Female
• Age: 55 Years
• Healthy volunteers: Accepted

Summary

Project 2 of the University of California, San Diego (UCSD) American Heart Association (AHA) Women's Health Program will assess 3-month changes in sitting time, standing time, physical activity and blood pressure in a randomized control trial (RCT). This 2-arm RCT will occur in the community with post menopausal Latina women (N=250) who spend at least 8 hrs/day sitting and have increased risk for cardiovascular disease through high BMI and other cardiometabolic risk factors. Women will be identified through the San Ysidro Health Center and assessed at the South Bay Latino Research Center.

Detailed description

Project 2 will address the following aims: 1. Investigate the 3 month effect of the intervention to impact the primary behavioral outcomes of sitting, standing and stepping time assessed objectively by a thigh worn inclinometer (ActivPAL) in Latinas at risk for heart disease. 2. Investigate the 3 month effect of the intervention to impact the secondary health outcomes of blood pressure, depressive symptoms, and anthropometrics. 3. Explore the psychosocial \& environmental mediators \& moderators of changes in sitting time.

Conditions

• Sedentary Lifestyle

Interventions

Type	Name	Description
DEVICE	ActivPAL inclinometer	Participants will wear a thigh-worn inclinometer for the first 3 weeks of the intervention, and at the mid-point of the intervention. The device will monitor their sitting and standing time.
BEHAVIORAL	Phone counseling call: Breaking up sitting time	Participants will receive 5 counseling phone calls to check-in on goal setting, strategies, and tools.
BEHAVIORAL	In-person counseling: Breaking up sitting time	Participants will receive 3 in-person health education sessions. At these sessions participants will receive feedback from the ActivPAL showing periods throughout the day where participants have been sitting. Participants will also develop action plans, check-in on goal setting, and use of tools at these sessions.
BEHAVIORAL	Phone counseling call: Healthy living	Participants will receive a healthy living educational intervention over the phone, developed and tested by the investigators in previous studies. Participants will not receive any information on diet, physical activity or sedentary behavior that may affect the outcomes.
OTHER	Tools to prompt standing	Investigators will provide standing desks to participants who spend time sitting at a computer. Additional tools to help prompt standing are mechanical and electronic timers set to interrupt long periods of sitting and cues in the environment such as standing during commercial breaks and phone calls.
BEHAVIORAL	In-person counseling: Healthy living	Control subjects will receive one in-person counseling session about healthy living. Participants will not receive any information on diet, physical activity or sedentary behavior that may affect the outcomes.

Timeline

• Start date: 2017-04-01
• Primary completion: 2020-04-15
• Completion: 2022-03-30
• First posted: 2016-09-19
• Last updated: 2022-10-04

Locations

2 sites across 1 country: United States