Mobile Health Intervention for Weight Gain Prevention

Overseen by Deborah F. Tate, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of North Carolina, Chapel Hill

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

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 .

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 data supports the effectiveness of the treatment Fit for Duty-mobile for weight gain prevention?

Research shows that mobile health (mHealth) interventions, like the Fit for Duty-mobile, can help with weight management by using technology such as smartphone apps and wearable devices to track activity and provide personalized coaching. These interventions have been found to support weight loss and maintenance, similar to in-person treatments, and can be effective in promoting healthy behaviors. ^{1 2 3 4 5}

Is the Mobile Health Intervention for Weight Gain Prevention safe for humans?

The research on mobile health interventions, including the use of fitness trackers like Fitbit, suggests they are generally safe for humans. These interventions have been used in various settings, such as worksite wellness programs and military training, without reported safety concerns. ^{6 7 8 9 10}

How is the Fit for Duty-mobile treatment different from other weight gain prevention treatments?

The Fit for Duty-mobile treatment is unique because it uses a mobile health (mHealth) approach that combines digital fitness trackers with personalized health coaching through automated messaging or individual coaches, aiming to enhance engagement and effectiveness in preventing weight gain. ^{1 4 6 7 11}

Research Team

Deborah F. Tate, PhD

Principal Investigator

Professor

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Fit for Duty-mobile (Behavioral Intervention)
• m-Health Control (Behavioral Intervention)

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.

Participant Groups

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+

Dr. Peggy P. McNaull

University of North Carolina, Chapel Hill

Chief Medical Officer

MD from Louisiana State University School of Medicine

Dr. Lynne Fiscus

University of North Carolina, Chapel Hill

Chief Executive Officer since 2020

MD from Georgetown University, MPH from UNC

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Dr. Gary H. Gibbons

National Heart, Lung, and Blood Institute (NHLBI)

Chief Executive Officer since 2012

MD from Harvard Medical School

Dr. James P. Kiley

National Heart, Lung, and Blood Institute (NHLBI)

Chief Medical Officer since 2011

MD from University of California, San Francisco

University of Virginia

Collaborator

Trials

802

Recruited

1,342,000+

James E. Ryan

University of Virginia

Chief Executive Officer since 2018

J.D. from Harvard Law School

Nikki Hastings

University of Virginia

Chief Medical Officer since 2018

Ph.D. in Biomedical Engineering from University of Virginia

Findings from Research

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]

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]

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]

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]

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]

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 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 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]

References

1. Canada 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. [2020]

2. Canada 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. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review of Application and Effectiveness of mHealth Interventions for Obesity and Diabetes Treatment and Self-Management. [2023]

4. Canada pubmed.ncbi.nlm.nih.gov

Smartloss: A Personalized Mobile Health Intervention for Weight Management and Health Promotion. [2023]

5. Canada pubmed.ncbi.nlm.nih.gov

Adoption and Appropriateness of mHealth for Weight Management in the Real World: A Qualitative Investigation of Patient Perspectives. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The Effects of a Mobile Wellness Intervention with Fitbit Use and Goal Setting for Workers. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

[Mobile health and excess weight: a systematic review]. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Effect of an accelerometer on body weight and fitness in overweight and obese active duty soldiers. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

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

10. England pubmed.ncbi.nlm.nih.gov

Military services fitness database: development of a computerized physical fitness and weight management database for the U.S. Army. [2021]

11. England pubmed.ncbi.nlm.nih.gov

A mobile health intervention for weight management among young adults: a pilot randomised controlled trial. [2022]