ObesityNCT06110273
Fit for Duty: mHealth Intervention for Weight Gain Prevention
A study testing Fit for Duty-mobile in people with Obesity, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Fit for Duty-mobile
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2023to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Joint Base San Antonio-Lackland
San Antonio, Texas, 28236
About this study
Official title: Preventing Weight Gain in U.S. Air Force Personnel Using a Novel Mobile Health Intervention
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 .
Read the 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
- Being tested
- Fit for Duty-mobile, m-Health Control
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fit for Duty-mobileBehavioural
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 ControlBehavioural
Participants receive digital tools and education on weight gain prevention behaviors at baseline.
| Study group | Role | What they receive |
|---|---|---|
| m-Health Control | Active comparator | This arm receives a digital fitness tracker, digital scale, and basic information about behavioral approaches for weight gain prevention. Receives: 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. Receives: Behavioral: Fit for Duty-mobile |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 2 years
Secondary outcomes (17)
Change in Weight
Absolute weight change from baseline up to 12 months. Weight will be objectively measured on a digital scale in the participant's home.
Measured: Baseline, up to 12 months
Prevention of weight gain
Proportion of participants in each study group (mHealth Control and Fit for Duty Mobile) that prevents weight gain at 2 years.
Measured: 2 years
Change in Dietary Intake as measured by the ASA-24 hour Recall
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.
Measured: Baseline, up to 24 months
Change in Physical Activity as measured by the Fitbit Activity Tracker
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.
Measured: Baseline, up to 24 months
Change in Competence for Diet and Physical Activity
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.
Measured: Baseline, 4 months, 12 months, 24 months
Change in Perceived Quality of Life as measured by the CDC Health Days Measure
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.
Measured: Baseline, up to 24 months
Change in Depression as measured by the CESD-Short Form
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.
Measured: Baseline, up to 24 months
Change in Weight Control Strategies
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.
Measured: Baseline, up to 24 months
Change in Perceived Stress as measured by the Perceived Stress Scale
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.
Measured: Baseline, up to 24 months
Eating Disorder Symptoms - Loss of Control Eating
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.
Measured: Baseline, up to 24 months
Eating Disorder Symptoms - Compensatory Behavior
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.
Measured: Baseline, up to 24 months
Change in self-efficacy for physical activity
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.
Measured: Baseline, up to 24 months
Change in Self-Regulation for Managing Weight
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.
Measured: Baseline, up to 24 months
Change in goal setting self-regulation behaviors as measured by the Short Self-Regulation Questionnaire Goal Setting subscale
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.
Measured: Baseline, up to 24 months
Change in Self-Efficacy for Diet as measured by the WEL-Q
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.
Measured: Baseline, up to 24 months
Reach (Re-AIM)
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.
Measured: Baseline
Representativeness (Re-AIM)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start11 Dec 2023
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deborah F. Tate, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110273
- Sponsor's protocol ID
- 19-1405
- Other IDs
- 5R01HL161836
- Status last verified
- Mar 2026
- First submitted
- 25 Oct 2023
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Weight Gain in U.S. Air Force Personnel Using a Novel Mobile Health Intervention
- ClinicalTrials.gov ID
- NCT06110273
- Acronym / sponsor ID
- 19-1405
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- University of Virginia, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| m-Health Control | Active comparator | Behavioral: m-Health ControlThis arm receives a digital fitness tracker, digital scale, and basic information about behavioral approaches for weight gain prevention. |
| Fit for Duty Mobile | Experimental | Behavioral: Fit for Duty-mobileThis arm receives a digital fitness tracker; digital scale; smartphone app which delivers a behavioral weight gain prevention intervention; and periodic coaching calls. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fit for Duty-mobileFit 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. | Behavioural | Fit for Duty Mobile |
| m-Health ControlParticipants receive digital tools and education on weight gain prevention behaviors at baseline. | Behavioural | m-Health Control |
Primary outcome
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.
17 secondary outcomes
Change in Weight
Time frame: Baseline, up to 12 months
Prevention of weight gain
Time frame: 2 years
Change in Dietary Intake as measured by the ASA-24 hour Recall
Time frame: Baseline, up to 24 months
Change in Physical Activity as measured by the Fitbit Activity Tracker
Time frame: Baseline, up to 24 months
Change in Competence for Diet and Physical Activity
Time frame: Baseline, 4 months, 12 months, 24 months
Change in Perceived Quality of Life as measured by the CDC Health Days Measure
Time frame: Baseline, up to 24 months
Change in Depression as measured by the CESD-Short Form
Time frame: Baseline, up to 24 months
Change in Weight Control Strategies
Time frame: Baseline, up to 24 months
Change in Perceived Stress as measured by the Perceived Stress Scale
Time frame: Baseline, up to 24 months
Eating Disorder Symptoms - Loss of Control Eating
Time frame: Baseline, up to 24 months
Eating Disorder Symptoms - Compensatory Behavior
Time frame: Baseline, up to 24 months
Change in self-efficacy for physical activity
Time frame: Baseline, up to 24 months
Change in Self-Regulation for Managing Weight
Time frame: Baseline, up to 24 months
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
Change in Self-Efficacy for Diet as measured by the WEL-Q
Time frame: Baseline, up to 24 months
Reach (Re-AIM)
Time frame: Baseline
Representativeness (Re-AIM)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah F. Tate, PhD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fit for Duty-mobile in people with Obesity, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Weight (time frame: Baseline, 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.