Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06110273

Fit for Duty: mHealth Intervention for Weight Gain Prevention

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 .

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Joint Base San Antonio-Lackland

San Antonio, Texas, 28236, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

m-Health Control

Behavioral

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

Primary outcomes

  1. Change in Weight

    Time frame: Baseline, 2 years

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

Secondary outcomes

  1. Change in Weight

    Time frame: Baseline, up to 12 months

    Absolute weight change from baseline up to 12 months. Weight will be objectively measured on a digital scale in the participant's home.

  2. Prevention of weight gain

    Time frame: 2 years

    Proportion of participants in each study group (mHealth Control and Fit for Duty Mobile) that prevents weight gain at 2 years.

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

    Time frame: Baseline, up to 24 months

    Changes in dietary intake from baseline up to 24 months will be assessed using the NCI Automated Self-Administered 24-hour Recall (ASA-24). Participants will complete one self-reported recall. Change in overall energy intake and saturated fat intake, as well as change in fruit and vegetable consumption, fiber consumption, and change in the Healthy Eating Inventory scores will be examined.

  4. Change in Physical Activity as measured by the Fitbit Activity Tracker

    Time frame: Baseline, up to 24 months

    Change in physical activity from baseline up to 24 months as measured using 1 week of data collected using the Fitbit activity monitor during each assessment period including total minutes of activity and steps.

  5. Change in Competence for Diet and Physical Activity

    Time frame: Baseline, 4 months, 12 months, 24 months

    Change in perceived competence from baseline up to 24 months as measured using 2 items from the The Perceived Competence for Scale. The Scale measures perceived competence for diet (4 items) and physical activity (4 items) and there are two subscales (diet and physical activity). Items are rated on a 7-point Likert scale (1 = not at all true, 7 = very true). One item from each subscale will be measured: "I feel confident in my ability to maintain a healthy diet" and "I feel confident in my ability to exercise regularly." The range for each item in each subscale is 1 - 7 with greater values indicating higher levels of perceived competence for engaging in positive diet and physical activity behaviors.

  6. Change in Perceived Quality of Life as measured by the CDC Health Days Measure

    Time frame: Baseline, up to 24 months

    The Centers for Disease Control and Prevention (CDC) Healthy Days Measure assesses a person's perceived sense of well-being through four questions on: 1) self-rated health, 2) number of recent days when physical health was not good, 3) number of recent days when mental health was not good, and 4) number of recent activity limitation days because of poor physical or mental health. Recent days is past 30.

    Scoring for this measurement tool is limited to an unhealthy days summary index is calculated by adding numbers 2 and 3 above with a maximum of 30 with higher values indicating poorer health. For self-rated health, items include Excellent, Very Good, Good, Fair, and Poor. For items 2-4, a greater number of days indicates more poor health in each category.

  7. Change in Depression as measured by the CESD-Short Form

    Time frame: Baseline, up to 24 months

    Center for Epidemiological Studies Depression Scale-Short Form (CESD) is a self-report 10-item scale designed to measure current depressive symptoms. Total score range from 0-30, with a score at or above 10 reflecting significant depressive symptomatology.

  8. Change in Weight Control Strategies

    Time frame: Baseline, up to 24 months

    Participants will be asked about frequency of use of 30 weight control strategies such as "I set a daily calorie goal for myself" used in the past month on a 5-point Likert scale from Never to Always. A total score is computed and ranges from 0 to 120 with higher scores indicating more frequent usage of the strategies. Factor analysis reflects a 4-factor structure: dietary choices, self-monitoring strategies, physical activity, and psychological coping.

  9. Change in Perceived Stress as measured by the Perceived Stress Scale

    Time frame: Baseline, up to 24 months

    The 4-item Perceived Stress Scale measures overall perceived stress during the past month. Items include how often you felt you could control the important things in your life, you felt confident about your ability to handle your personal problems, things were going your way, and you felt difficulties were piling up so you could not overcome them. Items are scored on as 5-point Likert scale from 0 (never) to 4 (very often). Scores range from 0 to 16, and higher scores indicate more stress.

  10. Eating Disorder Symptoms - Loss of Control Eating

    Time frame: Baseline, up to 24 months

    Participants will respond to an item derived from the revised Questionnaire on Eating and Weight Patterns (QEWP-5) to assess loss of control eating. Loss of control eating is assessed by endorsing the behavior one or more times per week over the reference period.

  11. Eating Disorder Symptoms - Compensatory Behavior

    Time frame: Baseline, up to 24 months

    Participants will respond to an items derived from the revised Questionnaire on Eating and Weight Patterns (QEWP-5) to assess compensatory behaviors. Compensatory behaviors are assessed as using any, on average, once per week during the reference period.

  12. Change in self-efficacy for physical activity

    Time frame: Baseline, up to 24 months

    The scale, consists of five items assessing confidence in participating in exercise in the presence of barriers such as feeling tired, being in a bad mood, not having time, on vacation, and experiencing bad weather. Response options are on a five point Likert-scale, ranging from not confident (1) to extremely confident (5). The score is an average of each item with a higher score indicating higher self-efficacy. Scores range from 1 to 5 with 5 indicating higher self-efficacy.

  13. Change in Self-Regulation for Managing Weight

    Time frame: Baseline, up to 24 months

    We will adapt the 15-item Dietary Self-Regulation Questionnaire to assess reasons for starting or continuing to manage weight (The reason I would manage my weight is...". Items are rated on a 7 point Likert scale from 1 (not at all true) to 7 (very true). Subscales include autonomous motivation (1, 3, 6, 8, 11, 13), externally controlled motivation (2, 4, 7, 9, 12, 14), and amotivation (5, 10, 15). Responses for each subscale score are averaged and higher numbers indicate higher levels of that type of motivation. Subscale scores range from 1 to 7.

  14. Change in goal setting self-regulation behaviors as measured by the Short Self-Regulation Questionnaire Goal Setting subscale

    Time frame: Baseline, up to 24 months

    Self-regulation behaviors will be assessed using the 10-item Goal Setting subscale of the Short Self-Regulation Questionnaire. Items are scored on a 1-5 scale (1=strongly disagree to 5=strongly agree ) and are be summed to create a total score with a maximum of 50 with higher scores indicating greater goal setting behaviors.

  15. Change in Self-Efficacy for Diet as measured by the WEL-Q

    Time frame: Baseline, up to 24 months

    The Weight Efficacy Lifestyle Questionnaire (WEL-Q)) Short Form will be used to assess participants' confidence in their ability to handle high-risk situations related to eating; 8 items ask participants to rate their confidence on an 11-point Likert scale ranging from 0 (not confident) to 10 (very confident). The WEL consists of five factors: negative emotions, availability, social pressure, physical discomfort, and positive activities. Items are summed for a total score (0-80). Higher scores indicated higher levels of self-efficacy for resisting eating.

  16. Reach (Re-AIM)

    Time frame: Baseline

    The number of potential participants approached, eligible and enrolled will be measured. Participation rate will be determined by dividing the total number of enrolled participants by the total number eligible to enroll.

  17. Representativeness (Re-AIM)

    Time frame: Baseline

    Representativeness will be assessed by comparing demographics, BMI and rank of those enrolled to: 1) those screened, eligible, and not enrolled and 2) to the demographics of the personnel at the study installations, the Air Force, and the US Military.

Other outcomes

  1. Implementation (Re-AIM)

    Time frame: Baseline to 24 months (across intervention)

    Fidelity of recruitment strategies: Estimates of potentially eligible participants will be measured by attendance records from recruitment events. Source of recruitment will be self-reported by participants. .

  2. Implementation (Re-AIM) coaching calls

    Time frame: Baseline to 24 months (across intervention)

    Fidelity of coaching calls: Will be measured by call completion records and staff checklist of intervention strategies delivered.

  3. Implementation (Re-AIM) app usage

    Time frame: Baseline to 24 months (across intervention)

    Fidelity of app usage: Will be measured by examining objective measures of logins, feature utilization, and content exposure.

  4. Effectiveness (Re-AIM)

    Time frame: 24 months

    Effectiveness will be measured primarily with the study's weight gain outcomes over time.

  5. Effectiveness (Re-AIM)

    Time frame: up to 24 months

    Effectiveness will also be measured by examining potential negative outcomes (e.g., loss of control eating and compensatory behavior, attrition) will also be used.

  6. Adoption (Re-AIM)

    Time frame: 24 months

    Potential for Organizational level Adoption will be estimated by summarizing stakeholders' willingness and perceptions of future adoption of SNAP-M for other bases and military branches.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of Virginia

Registry information

Official study title

Preventing Weight Gain in U.S. Air Force Personnel Using a Novel Mobile Health Intervention

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Oct 31, 2023
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.