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Promoting Lifestyle Change Via Tailored mHealth Feedback to Improve Health

NCT03367936 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 502

Last updated 2025-04-13

No results posted yet for this study

Summary

The overall purpose of this randomized clinical trial is to examine the effect and efficacy of the individualized, real-time, smartphone-based feedback of diet and physical activity self-monitoring on subsequent weight-control behaviors, weight loss outcomes and sustainability of patient engagement. Participants will be randomized to one of 2 groups: (1) Self-Monitoring -similar to what many people do on their own, subjects will self-monitor diet, physical activity using Fitbit and weight using a Bluetooth-enabled scale, and (2) Self-Monitoring +Feedback-participants will self-monitor as described for the Self-Monitoring group but also will receive tailored Feedback messages. The Self-Monitoring +Feedback participants will receive up to 4 daily discrete pop-up Feedback messages on the participant's smartphone delivered at random times during waking hours and tailored to content of recorded entries in the subjects' smartphone-based diaries and a weekly summary Feedback message about the participant's weight.

Conditions

  • Overweight and Obesity

Interventions

BEHAVIORAL

One-on-one Session

Participants will receive a 45-minute one-on-one behavioral lifestyle program for a healthful lifestyle and weight loss.

BEHAVIORAL

Self-monitoring

Participants will receive an orientation on how to self-monitor using the smartphone and other devises

BEHAVIORAL

Feedback

Participants will receive up to 4 daily feedback messages based on progress in attaining target behavior. The feedback messages will be delivered on a variable ratio schedule and tailored to data in subjects' dietary recordings

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • University of Pittsburgh

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2021-03-31
Completion
2021-03-31

Countries

  • United States

Study Locations

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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 NCT03367936 on ClinicalTrials.gov