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Behavioral Intervention
Mobile Health Intervention for Weight Gain Prevention
N/A
Recruiting
Led By Deborah F. Tate, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18-39
Be between 18 and 65 years old
Must not have
Past diagnosis of or receiving treatment for a clinically diagnosed eating disorder (anorexia nervosa or bulimia nervosa)
Previous surgical procedure for weight loss in past 5 years or planned weight loss surgery in the next year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to adapt a weight gain prevention program for young adults in the military using mobile tech to prevent weight gain over 2 years.
Who is the study for?
This trial is for active-duty Air Force members aged 18-39 stationed at select bases, with a BMI of 21-30. Participants must own a smartphone, expect to be at their base for over a year, and be willing to wear a Fitbit daily. Pregnant individuals or those planning pregnancy soon, people who've had weight loss surgery recently or plan to have it, and anyone with past eating disorders or in another weight loss program cannot join.
What is being tested?
The study tests an mHealth intervention called 'Fit for Duty-mobile' designed to prevent weight gain among young adult military personnel using mobile technology over two years. It adapts an evidence-based approach specifically for this population.
What are the potential side effects?
Since the intervention involves lifestyle changes through mobile health guidance and activity tracking rather than medication, typical medical side effects are not expected. However, participants may experience changes in physical activity patterns.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 39 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with or am being treated for an eating disorder.
Select...
I have had or plan to have weight loss surgery within 6 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Change in Competence for Diet and Physical Activity
Change in Depression as measured by the CESD-Short Form
Change in Dietary Intake as measured by the ASA-24 hour Recall
+14 moreOther study objectives
Adoption (Re-AIM)
Effectiveness (Re-AIM)
Implementation (Re-AIM)
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Fit for Duty MobileExperimental Treatment1 Intervention
This arm receives a digital fitness tracker; digital scale; smartphone app which delivers a behavioral weight gain prevention intervention; and periodic coaching calls.
Group II: m-Health ControlActive Control1 Intervention
This arm receives a digital fitness tracker, digital scale, and basic information about behavioral approaches for weight gain prevention.
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Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,935 Previous Clinical Trials
47,791,877 Total Patients Enrolled
254 Trials studying Obesity
211,039 Patients Enrolled for Obesity
University of VirginiaOTHER
782 Previous Clinical Trials
1,315,248 Total Patients Enrolled
18 Trials studying Obesity
2,009 Patients Enrolled for Obesity
University of North Carolina, Chapel HillLead Sponsor
1,557 Previous Clinical Trials
4,298,115 Total Patients Enrolled
65 Trials studying Obesity
57,990 Patients Enrolled for Obesity
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