Fit for Duty: mHealth Intervention for Weight Gain Prevention

NCT ID: NCT06110273

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2027-08-31

Brief Summary

Weight gain is disproportionately high among young adults compared to other age groups and of particular concern in the military, which is comprised largely of young adults, as obesity has emerged as a threat to national security. Despite the critical need to address weight gain in young military personnel who can face discharge for failing to meet weight standards, there is currently no evidence-based programs available to them. This study aims to adapt an evidence-based weight gain prevention intervention for delivery in a young adult, active-duty military population using mobile technology to prevent weight gain over 2 years .

Detailed Description

Weight gain is disproportionately high among young adults (YAs) with average weight gain of 30 lbs. occurring between ages 18-35 and is associated with an early worsening of cardiovascular disease risk factors. Primary prevention of weight gain is important because weight loss is difficult to achieve, access to programs is limited, and initially successful people regain weight over time. Weight gain is a serious problem in the Department of Defense, the nation's largest employer, with more employees than Walmart or Amazon. The military, comprised largely of YAs, has growing rates of obesity and yearly weight gain. Many people believe that young, active-duty men and women are fit, lean, and healthy because of the military lifestyle and protected from obesity. Unfortunately, obesity rates in active U.S. military personnel have mirrored those of civilians. Furthermore, inability to maintain a healthy weight results in early discharges and threatens the readiness of well-trained Airmen to be deployed. Overweight in the military is now considered a threat to national security. Few weight gain prevention (WGP) trials have been done in military populations, and previous trials with YAs have mixed results and poor external validity. This study is designed to address the major public health problem of weight gain in the military, as well as address notable gaps in pragmatic mHealth and WGP trials. The Fit for Duty intervention will be adapted, with partners and key stakeholder from the US Air Force, from the investigator's evidence-based WGP intervention for YAs, the Study of Novel Approaches to weight gain Prevention (SNAP). SNAP tested 2 self-regulatory interventions in 599 general population YAs and found that both reduced weight gain over 2-3 years compared to controls. This project proposes to make 1) critical adaptions to SNAP to facilitate translation and 2) conduct a Pragmatic Hybrid Type 1 Effectiveness Trial of the adapted intervention using a 2-group randomized controlled trial (RCT) design in 350 Air Force Airmen and other active duty military personnel recruited from military installations in and around San Antonio, TX, with the primary outcome of mean weight change from baseline to 2 years. The study will compare the groups on key outcomes and examine potential moderators of treatment effect. Additionally, the RE-AIM Framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance Framework) will be applied to determine reach and representativeness, and potential for organizational-level adoption and implementation of Fit for Duty, if successful. The proposed research fills key research gaps in an underserved population in critical need of weight gain prevention with completely remote delivery suitable for YAs in the military.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

m-Health Control

This arm receives a digital fitness tracker, digital scale, and basic information about behavioral approaches for weight gain prevention.

Group Type: ACTIVE_COMPARATOR

m-Health Control

Intervention Type: BEHAVIORAL

Participants receive digital tools and education on weight gain prevention behaviors at baseline.

Fit for Duty Mobile

This arm receives a digital fitness tracker; digital scale; smartphone app which delivers a behavioral weight gain prevention intervention; and periodic coaching calls.

Group Type: EXPERIMENTAL

Fit for Duty-mobile

Intervention Type: BEHAVIORAL

Fit for Duty-mobile participants will receive self-regulatory support and behavior change techniques via an initial core intervention delivered through a native smartphone app (includes connected device data, 10 weekly lessons, weekly tailored feedback) and 4 coaching calls (weeks 1, 4, 8, and 16). App based tailored feedback and messaging will continue through 2 years. Optional 4-week refresher e-campaigns are offered every 6 mos. after the initial core intervention. Participants choose to follow either a Small Changes approach or a Large Changes approach and may choose to switch approaches over the 2 years, if desired.

Interventions

Fit for Duty-mobile

Fit for Duty-mobile participants will receive self-regulatory support and behavior change techniques via an initial core intervention delivered through a native smartphone app (includes connected device data, 10 weekly lessons, weekly tailored feedback) and 4 coaching calls (weeks 1, 4, 8, and 16). App based tailored feedback and messaging will continue through 2 years. Optional 4-week refresher e-campaigns are offered every 6 mos. after the initial core intervention. Participants choose to follow either a Small Changes approach or a Large Changes approach and may choose to switch approaches over the 2 years, if desired.

Intervention Type: BEHAVIORAL

m-Health Control

Participants receive digital tools and education on weight gain prevention behaviors at baseline.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• age 18-39
• body mass index (BMI) of 21-30 kg/m^2
• own a smartphone with a data and text messaging plan;
• Active-Duty military personnel stationed at Joint Base San Antonio - Lackland, Joint Base San Antonio - Ft. Sam Houston, Sheppard Air Force Base or Keesler Air Force Base
• Anticipate being at their Station 12 months or more
• Willing and able to wear a Fitbit activity tracker daily for the duration of the study

Exclusion Criteria

• Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 12 months.
• Previous surgical procedure for weight loss in past 5 years or planned weight loss surgery in the next year.
• Past diagnosis of or receiving treatment for a clinically diagnosed eating disorder (anorexia nervosa or bulimia nervosa).
• Another member of the household is a participant in this same study
• Currently participating in a commercial weight loss program

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Virginia

OTHER

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Deborah F. Tate, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

Joint Base San Antonio-Lackland

San Antonio, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Karen E. Hatley, MPH, RD

Role: CONTACT

keericks@email.unc.edu

919-966-5853

Facility Contacts

Annette Martinez

Role: primary

Other Identifiers

5R01HL161836

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-1405

Identifier Type: -

Identifier Source: org_study_id