Digital Health Weight Management for Obesity

Overseen By Ziming Xuan, ScD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tufts Medical Center

Disqualifiers: Bipolar, Schizophrenia, Pregnancy, others

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

Compensation: Varies

Number of Visits: 6

Duration: 12 months

348 Participants Needed

Trial Summary

What is the purpose of this trial?

This research will test the efficacy of a weight management intervention through a three-group randomized trial: mHealth only, mHealth+Community Health Worker (CHW) support, versus control group, among residents of Boston's public housing developments. The mHealth group consists of a 1-year text messaging program to promote diet and physical activity behavior changes and the CHW support consists of monthly phone counseling delivered by a CHW to support the text messaging program. Our hypothesis is that the mHealth+CHW group will be more effective in bringing about weight loss compared to mHealth alone or the assessment only control group. The findings are expected to inform future health promotion efforts among residents in public housing developments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on a medically prescribed diet or fast that conflicts with the study, you may not be eligible to participate.

What data supports the effectiveness of the treatment CHW support, mHealth for weight management in obesity?

Research shows that digital and mobile health (mHealth) programs can be effective for weight management, offering similar weight loss results to traditional face-to-face methods. These programs are also seen as cost-effective and accessible, making them a viable option for managing obesity. ^{1 2 3 4 5}

Is digital health weight management safe for humans?

The research on digital health interventions for weight management, such as mHealth, primarily focuses on their effectiveness and user experience rather than safety concerns. There is no specific safety data mentioned, but these interventions are generally considered safe as they involve self-monitoring and educational components rather than medical procedures or drugs. ^{5 6 7 8 9}

How is the Digital Health Weight Management treatment for obesity different from other treatments?

This treatment is unique because it uses mobile health (mHealth) technology to provide weight management support through digital platforms, making it more accessible and potentially more cost-effective than traditional face-to-face methods. It also emphasizes social support and behavior change techniques tailored to diverse needs, which can enhance user engagement and compliance. ^{1 3 4 8 10}

Research Team

Lisa Quintiliani, PhD

Principal Investigator

Tufts Medical Center

Ziming Xuan, ScD

Principal Investigator

BU School of Public Health, Community Health Services

Eligibility Criteria

This trial is for Boston public housing residents who are not in a weight loss program, don't have certain mental health conditions untreated by medication, aren't pregnant, and have no medical issues preventing exercise. Participants must be able to text and wear an activity tracker.

Inclusion Criteria

Has cell phone with a plan that allows for unlimited text messages

I am willing to wear a physical activity tracker.

Current resident of Boston public housing development

Exclusion Criteria

I get short of breath with very low activity despite using aids.

I frequently experience heart or chest pain.

My blood pressure often exceeds 175/110.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 12-month text messaging program to promote diet and physical activity behavior changes. The mHealth+CHW group also receives monthly phone counseling by a Community Health Worker.

12 months

Monthly phone counseling for mHealth+CHW group

Follow-up

Participants are monitored for changes in weight, physical activity, and psycho-social variables at 6-month and 12-month follow-ups.

12 months

Follow-up assessments at 6 and 12 months

Treatment Details

Interventions

• CHW support
• mHealth

Trial Overview The study tests a weight management intervention comparing three groups: one using mobile health (mHealth) tech, another adding Community Health Worker support to mHealth, and a control group. It aims to see if the combined approach is more effective.

Participant Groups

Group I: mHealth+Community Health Worker (CHW) support Experimental Treatment 2 Interventions

same as mHealth group + monthly behavioral phone counseling by a CHW

Group II: mHealth Group Experimental Treatment 1 Intervention

12 month text messaging program about diet and physical activity behavioral goals

Group III: Control group Active Control 1 Intervention

Assessments only

Who Is Running the Clinical Trial?

Tufts Medical Center

Lead Sponsor

Trials

264

Recruited

264,000+

Boston Medical Center

Lead Sponsor

Trials

410

Recruited

890,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

In a study of 940 adult users of the DrHolmApp, 71% experienced a reduction in body mass index (BMI), with an average decrease of 0.63 BMI points, indicating the app's effectiveness in promoting weight loss.

Users also reported significant improvements in physical activity, mood, quality of life, and body image satisfaction, suggesting that the app not only aids in weight loss but also enhances overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal evaluation of an mHealth overweight and obesity management tool. Langkjær, IOJ., Fonvig, CE., Holm, LA., et al.[2022]

Users prefer mHealth weight loss apps that are simple, attractive, and allow for self-monitoring with feedback, emphasizing the importance of personalization and engaging content.

Key barriers to using these apps include technological issues and message overload, highlighting the need for careful consideration of message tone, structure, and delivery frequency to enhance user experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumer perspectives on mHealth for weight loss: a review of qualitative studies. Lyzwinski, LN., Caffery, LJ., Bambling, M., et al.[2018]

A systematic review of 21 randomized controlled trials found strong evidence that mobile technology interventions can lead to short-term weight loss in overweight and obese adults, with moderate evidence for medium-term effects.

The review highlighted the importance of improving future trial reporting, suggesting that weight loss should be reported as a percentage and emphasizing the need for long-term follow-up and assessments of cost-effectiveness and patient acceptability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions employing mobile technology for overweight and obesity: an early systematic review of randomized controlled trials. Bacigalupo, R., Cudd, P., Littlewood, C., et al.[2022]

Self-reported weights in a weight loss trial showed increasing underestimation over time, with an average difference of -0.5 kg at 6 months and -1.1 kg at 24 months, indicating that participants were less accurate in reporting their weights as the study progressed.

Participants who accurately reported their weights were more likely to achieve the weight loss goal, with a 9% misclassification rate in achieving the 5% weight loss goal when using self-reported weights compared to clinic measurements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal accuracy of web-based self-reported weights: results from the Hopkins POWER Trial. Jerome, GJ., Dalcin, A., Coughlin, JW., et al.[2022]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

A service evaluation exploring the effectiveness of a locally commissioned tier 3 weight management programme offering face-to-face, telephone and digital dietetic support. [2021]

2. China pubmed.ncbi.nlm.nih.gov

Longitudinal evaluation of an mHealth overweight and obesity management tool. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Digital consultations for weight management in the NHS: A qualitative evaluation. [2023]

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

Development of an Evidence-Based mHealth Weight Management Program Using a Formative Research Process. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Consumer perspectives on mHealth for weight loss: a review of qualitative studies. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Interventions employing mobile technology for overweight and obesity: an early systematic review of randomized controlled trials. [2022]

7. England pubmed.ncbi.nlm.nih.gov

eHealth interventions for the prevention and treatment of overweight and obesity in adults: a systematic review with meta-analysis. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

A Mixed-Methods Approach to the Development, Refinement, and Pilot Testing of Social Networks for Improving Healthy Behaviors. [2022]

9. Canada pubmed.ncbi.nlm.nih.gov

Longitudinal accuracy of web-based self-reported weights: results from the Hopkins POWER Trial. [2022]

10. 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]