Status:

COMPLETED

Promoting Lifestyle Change Via Tailored mHealth Feedback to Improve Health

Lead Sponsor:

University of Pittsburgh

Collaborating Sponsors:

National Institutes of Health (NIH)

National Heart, Lung, and Blood Institute (NHLBI)

Conditions:

Overweight and Obesity

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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...

Detailed Description

This study includes the following activities: 1. Screening: Phase I: It will be conducted online. Respondents to recruitment solicitations will be provided an online Uniform Resource Locator (URL...

Eligibility Criteria

Inclusion

  • Currently own and regularly use a smartphone
  • Age ≥18 years;
  • BMI \> 27 and \< 43; and
  • Successful completion of a 5-day electronic diary of food intake during a run-in period.

Exclusion

  • Presence of an unstable condition requiring physician-supervised diet and exercise (e.g., recent myocardial infarction);
  • Physical limitations precluding ability to engage in moderate-intensity physical activity;
  • Pregnancy or intention to become pregnant during study;
  • Current treatment for a serious mental illness (e.g. schizophrenia);
  • Reported alcohol intake \> 4 drinks/day;
  • Participation in a formal weight loss program, loss of ≥ 5% weight in past 6 month, or current use of weight loss medication;
  • History of bariatric surgery in \<5 years,
  • Planned extended vacations, absences, or relocation during study;
  • A score \>16 on the Center for Epidemiologic Studies Depression Scale (CES-D);
  • Score \>32 on the Eating Habits Checklist, an eating disorder scale administered at baseline. For those who have an elevated BDI score (\>22) or EHC (\>32), we offer referral for counseling.

Key Trial Info

Start Date :

August 1 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 31 2021

Estimated Enrollment :

502 Patients enrolled

Trial Details

Trial ID

NCT03367936

Start Date

August 1 2018

End Date

March 31 2021

Last Update

April 13 2025

Active Locations (1)

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1

University of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15261