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Behavioral Intervention

Intervention Program for Obesity

N/A
Waitlist Available
Led By Gary G Bennett, PhD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months post-randomization (up to 27 months to obtain 24 month data)
Awards & highlights

Study Summary

This trial is testing a digital health platform to help prevent weight gain in obese patients who are not interested in or ready for weight loss.

Eligible Conditions
  • Obesity
  • Malnutrition
  • Overnutrition
  • Symptoms

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months post-randomization (up to 27 months to obtain 24 month data)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months post-randomization (up to 27 months to obtain 24 month data) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Change in Framingham risk score
Change in blood pressure
Change in weight
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention ProgramExperimental Treatment1 Intervention
Balance Intervention Program: Participants randomly assigned to the 12-month digital health behavioral intervention will receive: tailored behavior change goals with interactive self-monitoring and feedback; network-connected scales to track their weight; skills training materials; and stepped coaching (via phone and/or text) from Registered Dieticians serving as health coaches within a local network of community health centers.
Group II: Usual Care ProgramActive Control1 Intervention
Balance Usual Care Program: Participants randomly assigned to the Usual Care program will receive the standard primary care offered by their providers; health information/skills training materials to maintain a healthy weight; and automated (non-tailored) text messages with health information.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intervention Program
2017
N/A
~7330

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,367 Previous Clinical Trials
3,424,404 Total Patients Enrolled
81 Trials studying Obesity
31,326 Patients Enrolled for Obesity
Gary G Bennett, PhDPrincipal InvestigatorDuke University
5 Previous Clinical Trials
1,073 Total Patients Enrolled
3 Trials studying Obesity
719 Patients Enrolled for Obesity
Dori M Steinberg, PhD, RDPrincipal InvestigatorDuke University
2 Previous Clinical Trials
109 Total Patients Enrolled
1 Trials studying Obesity
50 Patients Enrolled for Obesity

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it still possible to enrol in this research project?

"Based on clinicaltrials.gov, this trial is not currently accepting participants; it was initially posted in January 2017 and last updated in July 2022. However, there are presently 1207 other studies that remain actively recruiting patients."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Alabama
North Carolina
Other
How old are they?
65+
18 - 65
What site did they apply to?
Duke University - with Piedmont Health Services, Inc.
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

I’ve been on 5 drugs with minimal results. I need help!
PatientReceived 2+ prior treatments
Recent research and studies
BMC Public HealthJournal
The Balance Protocol: A Pragmatic Weight Gain Prevention Randomized Controlled Trial for Medically Vulnerable Patients Within Primary Care
Berger, Miriam B., Dori M. Steinberg, Sandy Askew, John A. Gallis, Cayla C. Treadway, Joseph R. Egger, Melissa C. Kay, et al.. 2019. “The Balance Protocol: A Pragmatic Weight Gain Prevention Randomized Controlled Trial for Medically Vulnerable Patients Within Primary Care”. BMC Public Health. Springer Science and Business Media LLC. doi:10.1186/s12889-019-6926-7.
clinicaltrials.govStudy
Balance: A Pragmatic Trial of a Digital Health Intervention to Prevent Weight Gain in Primary Care
2017. "Balance: A Pragmatic Trial of a Digital Health Intervention to Prevent Weight Gain in Primary Care". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03003403.
~53 spots leftby May 2025
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