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

Not Applicable

Completed

• Conditions: Sedentary Lifestyle

• Registration Number: NCT02905929
• Lead Sponsor: University of California, San Diego

Brief 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.

Study Timeline

• Study First Submitted: 2016-09-09
• Study First Submitted QC: 2016-09-13
• Study First Posted: 2016-09-19
• Study Start: 2017-04-01
• Primary Completion: 2020-04-15
• Study Completion: 2022-03-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-01
• Last Update Posted: 2022-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 254

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sitting, standing and stepping time	3 months	Change in daily time spent sitting, standing and stepping during waking hours as measured objectively by the ActivPAL

Secondary Outcome Measures

Name	Time	Method
Psychosocial and environmental mediators: habit formation	3 months	Assessed using the Self-Report Habit Index
Anthropometrics	3 months	Change in body mass index (BMI)
Psychosocial and environmental mediators: benefits and barriers	3 months	Investigators will use measures adapted for our pilot that include benefits and barriers to sitting less.
Psychosocial and environmental mediators: self-efficacy	3 months	Investigators will use measures adapted for our pilot including self-efficacy to sit less.
Demographic moderators: retirement status	3 months	Self-reported items on the baseline survey. Some of these demographic variables will also be considered covariates in analyses.
Demographic moderators: age	3 months	Self-reported items on the baseline survey. Some of these demographic variables will also be considered covariates in analyses.
Demographic moderators: education	3 months	Self-reported items on the baseline survey. Some of these demographic variables will also be considered covariates in analyses.
Blood pressure	3 months	Change in blood pressure
Depressive symptoms	3 months	Change in depressive symptoms, measured with Center for Epidemiologic Studies Depression (CESD) short form. Scores greater than 10 indicate probable depressive symptoms.
Psychosocial and environmental mediators: home environment support	3 months	Investigators will use measures adapted for our pilot including home environment support surrounding sitting less.
Improvement in Quality of Life	3 months	Change in quality of life, measured with the EURO-QOL 5-D, a brief 5 item standard scale that has demonstrated validity in populations with diabetes and cardiovascular diseases.
Psychosocial and environmental mediators: social support	3 months	Investigators will use measures adapted for our pilot including social support surrounding sitting less.
Demographic moderators: sex	3 months	Self-reported items on the baseline survey. Some of these demographic variables will also be considered covariates in analyses.
Demographic moderators: marital status	3 months	Self-reported items on the baseline survey. Some of these demographic variables will also be considered covariates in analyses.

Trial Locations

Locations (2)

South Bay Latino Research Center; 🇺🇸 Chula Vista, California, United States

UCSD; 🇺🇸 San Diego, California, United States