Clinical trial NCT06110273: Fit for Duty: mHealth Intervention for Weight Gain Prevention
Official title: Preventing Weight Gain in U.S. Air Force Personnel Using a Novel Mobile Health Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: University of Virginia
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-10-31
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in Weight
timeFrame: Baseline, 2 years
Secondary outcomes:
measure: Change in Weight
timeFrame: Baseline, up to 12 months
measure: Prevention of weight gain
timeFrame: 2 years
measure: Change in Dietary Intake as measured by the ASA-24 hour Recall
timeFrame: Baseline, up to 24 months
measure: Change in Physical Activity as measured by the Fitbit Activity Tracker
timeFrame: Baseline, up to 24 months
measure: Change in Competence for Diet and Physical Activity
timeFrame: Baseline, 4 months, 12 months, 24 months
measure: Change in Perceived Quality of Life as measured by the CDC Health Days Measure
timeFrame: Baseline, up to 24 months
measure: Change in Depression as measured by the CESD-Short Form
timeFrame: Baseline, up to 24 months
measure: Change in Weight Control Strategies
timeFrame: Baseline, up to 24 months
measure: Change in Perceived Stress as measured by the Perceived Stress Scale
timeFrame: Baseline, up to 24 months
measure: Eating Disorder Symptoms - Loss of Control Eating
timeFrame: Baseline, up to 24 months
measure: Eating Disorder Symptoms - Compensatory Behavior
timeFrame: Baseline, up to 24 months
measure: Change in self-efficacy for physical activity
timeFrame: Baseline, up to 24 months
measure: Change in Self-Regulation for Managing Weight
timeFrame: Baseline, up to 24 months
measure: Change in goal setting self-regulation behaviors as measured by the Short Self-Regulation Questionnaire Goal Setting subscale
timeFrame: Baseline, up to 24 months
measure: Change in Self-Efficacy for Diet as measured by the WEL-Q
timeFrame: Baseline, up to 24 months
measure: Reach (Re-AIM)
timeFrame: Baseline
measure: Representativeness (Re-AIM)
timeFrame: Baseline
Other outcomes:
measure: Implementation (Re-AIM)
timeFrame: Baseline to 24 months (across intervention)
measure: Implementation (Re-AIM) coaching calls
timeFrame: Baseline to 24 months (across intervention)
measure: Implementation (Re-AIM) app usage
timeFrame: Baseline to 24 months (across intervention)
measure: Effectiveness (Re-AIM)
timeFrame: 24 months
measure: Effectiveness (Re-AIM)
timeFrame: up to 24 months
measure: Adoption (Re-AIM)
timeFrame: 24 months
Locations:
city: San Antonio
country: United States
facility: Joint Base San Antonio-Lackland
state: Texas
Study officials:
affiliation: Professor
name: Deborah F. Tate, PhD
role: PRINCIPAL_INVESTIGATOR
References: