Mobile Health Intervention for Weight Gain Prevention

Overseen By Karen E. Hatley, MPH, RD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Pregnancy, Weight loss surgery, Eating disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile health program called "Fit for Duty-mobile" to help prevent weight gain in young adults serving in the military. Participants will either receive a digital fitness tracker, scale, and basic weight management information, or they will receive those tools plus a smartphone app and coaching calls for more personalized support. The trial seeks active-duty military personnel with a BMI (a measure of body fat based on height and weight) between 21 and 30, who own a smartphone, and are stationed at specific bases for at least 12 months. The goal is to find effective ways to keep military members fit and ready for duty. As an unphased trial, this study offers participants the chance to contribute to innovative research aimed at enhancing military fitness and readiness.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this mobile health intervention is safe for weight gain prevention?

Research has shown that using fitness trackers, such as those in the "Fit for Duty Mobile" program, is generally safe. Other studies have used these devices without major safety issues. No reports of serious side effects have emerged from using digital fitness trackers or scales. Most people find these devices easy to use. The "Fit for Duty Mobile" program also includes a smartphone app and coaching calls, which provide safe communication methods. Overall, evidence suggests that this program is safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mobile Health Intervention for Weight Gain Prevention because it leverages modern technology in a unique way. Unlike traditional weight management methods that often rely on in-person counseling and static resources, this intervention uses a smartphone app to deliver a dynamic and personalized behavioral program. The "Fit for Duty Mobile" arm is especially innovative as it combines a digital fitness tracker, a digital scale, and regular coaching calls, offering a comprehensive, interactive experience that can adapt to each user's needs. This approach has the potential to make weight management more accessible and engaging, providing support anytime and anywhere, which could lead to better long-term outcomes for users.

What evidence suggests that this trial's treatments could be effective for weight gain prevention?

Research has shown that the "Fit for Duty-mobile" program, one of the interventions in this trial, might help young military members avoid weight gain by using mobile health tools. Studies have found that similar programs, which use digital fitness trackers and personalized health coaching, can effectively manage weight. Participants in the "Fit for Duty Mobile" arm will receive digital tools like fitness trackers and scales, along with a smartphone app that provides guidance and coaching calls. These features aim to help users maintain a healthy weight through regular monitoring and personalized advice. While results can vary, past programs have shown promise in reducing weight gain in similar groups. ^{1 2 3 6 7}

Who Is on the Research Team?

Deborah F. Tate, PhD

Principal Investigator

Professor

Are You a Good Fit for This Trial?

This trial is for active-duty Air Force members aged 18-39 stationed at select bases, with a BMI of 21-30. Participants must own a smartphone, expect to be at their base for over a year, and be willing to wear a Fitbit daily. Pregnant individuals or those planning pregnancy soon, people who've had weight loss surgery recently or plan to have it, and anyone with past eating disorders or in another weight loss program cannot join.

Inclusion Criteria

You possess a smartphone with an accompanying data and text messaging plan.

Your BMI is between 21 and 30 kg/m^2.

You are an active-duty Air Force personnel stationed at one of the following: Joint Base San Antonio - Lackland, Joint Base San Antonio - Ft

Exclusion Criteria

I have been diagnosed with or am being treated for an eating disorder.

Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 12 months

Currently participating in a commercial weight loss program

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a mobile health intervention to prevent weight gain, including a digital fitness tracker, digital scale, smartphone app, and periodic coaching calls

24 months

Remote delivery with periodic virtual coaching calls

Follow-up

Participants are monitored for weight change and other health outcomes after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fit for Duty-mobile
• m-Health Control

Trial Overview The study tests an mHealth intervention called 'Fit for Duty-mobile' designed to prevent weight gain among young adult military personnel using mobile technology over two years. It adapts an evidence-based approach specifically for this population.

How Is the Trial Designed?

Group I: Fit for Duty Mobile Experimental Treatment 1 Intervention

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

Group II: m-Health Control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

University of Virginia

Collaborator

Trials

802

Recruited

1,342,000+

Published Research Related to This Trial

A 12-week mobile health (mHealth) intervention for university students showed some positive changes in weight and lifestyle behaviors, including a mean weight loss of 1.6 kg and increased physical activity.

Despite these improvements, the changes were not significantly different from the control group, suggesting that higher engagement and personalized support may be necessary for more effective outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mobile health intervention for weight management among young adults: a pilot randomised controlled trial. Hebden, L., Cook, A., van der Ploeg, HP., et al.[2022]

SmartLoss is a semiautomated mobile health platform designed for weight loss, utilizing a dynamic energy balance model to provide personalized caloric prescriptions and recommendations based on real-time data from users.

The platform includes a clinician dashboard and integrates with connected devices like scales and accelerometers, allowing for efficient remote monitoring and tailored interventions, which may enhance adherence and treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartloss: A Personalized Mobile Health Intervention for Weight Management and Health Promotion. Martin, CK., Gilmore, LA., Apolzan, JW., et al.[2023]

In a study involving 24 veterans, it was found that while most participants believed mHealth interventions for weight management were appropriate, many did not complete the registration process, indicating that initial adoption requires more than just a single invitation.

Key barriers to mHealth adoption included preferences for in-person care and challenges with self-monitoring, suggesting that successful implementation should consider user preferences and provide multiple options for engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adoption and Appropriateness of mHealth for Weight Management in the Real World: A Qualitative Investigation of Patient Perspectives. Breland, JY., Agha, K., Mohankumar, R.[2022]

In a study of 28 overweight/obese active duty soldiers over 6 months, using a web-linked accelerometer combined with mandatory physical training did not lead to significant weight loss or improvements in fitness outcomes compared to usual care.

Both groups showed minimal changes in weight and body fat, with no significant differences in blood pressure or heart rate, indicating that the accelerometer did not enhance the effectiveness of the physical training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of an accelerometer on body weight and fitness in overweight and obese active duty soldiers. Shrestha, M., Combest, T., Fonda, SJ., et al.[2019]

In a study of 404 ROTC cadets, women had a lower body mass index (BMI) than men and were more likely to adopt healthy weight loss strategies, such as reducing fried foods and sweets.

Both male and female cadets showed a strong willingness to participate in mobile health (m-health) programs for weight management, with women particularly interested in using apps for tracking food, activity, and managing stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight Loss Strategies Used by Army Reserve Officer Training Corps Cadets: Implication for Student Health and Wellness Services. Wilson, JA., James, DC.[2020]

The mHealth system, which included a smartphone app and external sensors, was found to be highly acceptable and usable among 26 high school students, receiving a 'Good' grade of 77.1 on the System Usability Scale.

Participants showed increased compliance in recording their dietary habits, with meal registration frequency rising from 70% in the first week to 76% in the second week, indicating that the system could effectively help monitor dietary habits in real life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Formative Evaluation of a Smartphone App for Monitoring Daily Meal Distribution and Food Selection in Adolescents: Acceptability and Usability Study. Langlet, B., Maramis, C., Diou, C., et al.[2021]

The Military Services Fitness Database (MSFD) was developed to effectively track and manage data on the weight, body fat percentage, and fitness levels of military personnel over time.

A 2.5-year pilot test demonstrated that the MSFD successfully monitors trends in body weight, body fat percentage, and fitness, providing valuable insights for the Army Weight Control Program and physical fitness assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Military services fitness database: development of a computerized physical fitness and weight management database for the U.S. Army. Williamson, DA., Bathalon, GP., Sigrist, LD., et al.[2021]

A study involving 79 workers from manufacturing companies showed that a mobile wellness intervention using Fitbit, along with goal setting and motivational support, significantly improved wellness, physical activity behavior, daily walking steps, and self-efficacy compared to a control group.

The results suggest that while Fitbits can track activity, combining them with counseling and tailored messaging is crucial for effectively encouraging behavior change in physically inactive workers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of a Mobile Wellness Intervention with Fitbit Use and Goal Setting for Workers. Lee, SH., Ha, Y., Jung, M., et al.[2020]

A systematic review of 14 studies found that mobile health (mHealth) technologies, particularly mobile phones and text messaging, positively impacted weight management outcomes in adults, with 13 studies showing beneficial effects on weight, BMI, or waist circumference.

mHealth technologies can be effective tools for both preventing weight gain and treating overweight or obesity, making them accessible options for many people since mobile phones are widely used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mobile health and excess weight: a systematic review]. Sarno, F., Canella, DS., Bandoni, DH.[2019]

A systematic review of 24 mHealth studies on obesity and diabetes treatment showed that over 50% reported positive outcomes, including weight loss and blood glucose reduction, indicating the potential effectiveness of mobile technologies in managing chronic diseases.

Despite promising results, most studies had small sample sizes and short intervention durations, highlighting the need for future research with larger groups and longer follow-up periods to better assess the long-term efficacy of mHealth interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Application and Effectiveness of mHealth Interventions for Obesity and Diabetes Treatment and Self-Management. Wang, Y., Xue, H., Huang, Y., et al.[2023]

The study aims to evaluate the effectiveness of a mobile app called Stay Strong, which tracks physical activity and weight in veterans, comparing the impact of the app alone versus the app combined with personalized health coaching over a year.

With 357 veterans enrolled, the trial will assess whether adding coaching features, such as tailored messaging and phone calls, enhances physical activity levels compared to using the app without coaching.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding the Effect of Adding Automated and Human Coaching to a Mobile Health Physical Activity App for Afghanistan and Iraq Veterans: Protocol for a Randomized Controlled Trial of the Stay Strong Intervention. Buis, LR., McCant, FA., Gierisch, JM., et al.[2020]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06110273/fit-for-duty-mhealth-intervention-for-weight-gain-prevention

Fit for Duty: mHealth Intervention for Weight Gain Prevention This study aims to adapt an evidence-based weight gain prevention intervention for delivery in a young adult, active-duty military population ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02679937

Prevention of Obesity in Military Communities - Fit4Duty The goal of this study is to test the effectiveness of a dissonance-based, weight-gain prevention program (Fit4Duty) to prevent excess weight gain among service ...

3. withpower.com withpower.com/trial/mobile-health-intervention-for-weight-gain-prevention-02dbc

Mobile Health Intervention for Weight Gain Prevention The Fit for Duty-mobile treatment is unique because it uses a mobile health (mHealth) approach that combines digital fitness trackers with personalized health ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10877670/

Mobile health (m‐health) smartphone interventions for ... A smartphone app may reduce BMI in the medium‐term, but the evidence is very uncertain. There was probably little or no change in weight two years after the ...

5. jmir.org jmir.org/2024/1/e51714/

Effectiveness of Digital Health Interventions in Promoting ... Objective: This study aims to examine the impact of digital health interventions on physical activity behaviors among college students, using ...

6. peearz.com peearz.com/trialsindex?nctid=NCT06110273

Fit for Duty: mHealth Intervention for Weight Gain Prevention This study aims to adapt an evidence-based weight gain prevention intervention for delivery in a young adult, active-duty military population using mobile ...

7. jmir.org jmir.org/2025/1/e69451

Effects of an Exercise Intervention Based on mHealth ... Results: At the end of the intervention, the BMI of the online and offline groups decreased by 0.89(SD 1.17) and 0.68(SD 0.94)kg/m², ...