CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 254 enrolled
Drug / intervention
ActivPAL inclinometer +5 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02905929
NCT02905929N/ACompleted

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

University of California, San Diego·interventional·Posted Sep 19, 2016·Updated Oct 4, 2022

In Brief

A clinical study evaluating ActivPAL inclinometer, Phone counseling call: Breaking up sitting time, and 4 other interventions for Sedentary Lifestyle. Completed, enrolled 254 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedSep 19, 2016
Enrollment StartApr 1, 2017
Primary CompletionApr 15, 2020
Study CompletionMar 30, 2022
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 9.8 years ago

Interventions

ActivPAL inclinometerdevice

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.

Phone counseling call: Breaking up sitting timebehavioral

Participants will receive 5 counseling phone calls to check-in on goal setting, strategies, and tools.

In-person counseling: Breaking up sitting timebehavioral

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.

Phone counseling call: Healthy livingbehavioral

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.

Tools to prompt standingother

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.

In-person counseling: Healthy livingbehavioral

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.