Fit for Duty: mHealth Intervention for Weight Gain Prevention

NCT06110273 | Active Not Recruiting

• 2 other identifiers: 19-14055R01HL161836
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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 .

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Change in Weight

  Absolute weight change from baseline to 2 years. Weight will be objectively measured on a digital scale in the participant's home.

  Baseline, 2 years

Secondary Outcomes (17)

• Change in Weight

  Baseline, up to 12 months

• Prevention of weight gain

  2 years

• Change in Dietary Intake as measured by the ASA-24 hour Recall

  Baseline, up to 24 months

• Change in Physical Activity as measured by the Fitbit Activity Tracker

  Baseline, up to 24 months

• Change in Competence for Diet and Physical Activity

  Baseline, 4 months, 12 months, 24 months

Other Outcomes (6)

• Implementation (Re-AIM)

  Baseline to 24 months (across intervention)

• Implementation (Re-AIM) coaching calls

  Baseline to 24 months (across intervention)

• Implementation (Re-AIM) app usage

  Baseline to 24 months (across intervention)

Study Arms (2)

m-Health Control

ACTIVE COMPARATOR

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

Behavioral: m-Health Control

Fit for Duty Mobile

EXPERIMENTAL

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

Behavioral: Fit for Duty-mobile

Interventions

Fit for Duty-mobile 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.

Fit for Duty Mobile

m-Health Control BEHAVIORAL

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

m-Health Control

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: collaborator
• University of North Carolina, Chapel Hill: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Joint Base San Antonio-Lackland

San Antonio, Texas, 28236, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Deborah F. Tate, PhD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: October 31, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)