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Sedentary Behavior Interrupted Randomized Controlled Trial (P2)

NCT03473145 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 407

Last updated 2025-11-03

Study results available
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Summary

Epidemiological findings indicate that older adults do not meet physical activity (PA) guidelines \& spend up to 11 hrs/day sitting. Given the high prevalence of sedentary behavior (SB), the higher chronic disease risk in this population, \& the age-associated challenges of meeting traditional PA guidelines, involving longer bouts of moderate PA, the investigators hypothesize that older adult health will benefit from new strategies to interrupt sitting. This protocol "Sedentary Behavior Interrupted: A randomized trial of 3-month effects on biomarkers of healthy aging and physical functioning in the real world (Project 2)" is part of a National Institutes of Aging Program Grant called "Sedentary Time \& Aging Mortality and Physical Function (STAR). The overall purpose of the STAR program to is to better understand how to interrupt sitting time and the consequences for healthy aging in postmenopausal women. This protocol (also referred to Project 2 of the STAR program) is a 3-arm randomized control trial designed to assess ways of interrupting sitting in 405 overweight, postmenopausal women.

Conditions

  • Sedentary Lifestyle

Interventions

BEHAVIORAL

Health Coaching

Health Coaching sessions will be aimed at goal setting, implementing strategies, overcoming barriers, \& relapse prevention.

DEVICE

activPAL inclinometer

Participants in the intervention study arms (B \& C) will wear the ActivPAL device for the first 4 weeks of the program and then again in weeks 8 and 9. The device will monitor their sitting and standing time and will allow Health Coaches to provide feedback and will assist the participant in developing an action plan.

OTHER

Tools to Prompt Standing or Prompt Sit-to-Stand Transitions.

Participants in the intervention study arms (B \& C) will receive tools to prompt standing or sit-to-stand transitions such as wearable wrist devices, standing desks or tables (Group B only), mechanical and/or electronic timers, or access to mobile apps or computer programs.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-30
Primary Completion
2022-12-31
Completion
2024-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03473145 on ClinicalTrials.gov