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

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.

Conditions

• Sedentary Lifestyle

Interventions

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.

Sponsors & Collaborators

• South Bay Latino Research Center

  collaborator UNKNOWN

• San Ysidro Health Center

  collaborator OTHER

• San Diego State University

  collaborator OTHER

• University of California, San Diego

  lead OTHER

Principal Investigators

• Matthew Allison, MDD · University of California, San Diego

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

55 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-04-01

Primary Completion

2020-04-15

Completion

2022-03-30

Countries

• United States

Study Locations