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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a weight management program for residents of Boston's public housing. It compares three groups: one using a mobile health (mHealth) text messaging program, another using mHealth plus support from a Community Health Worker (CHW) through phone counseling, and a control group receiving no intervention. The goal is to determine if the combined mHealth and CHW approach results in more weight loss than mHealth alone or no treatment. Residents who live in Boston public housing, speak English or Spanish, and have a phone plan with unlimited texts might be suitable participants. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance weight management strategies for communities.

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 prior data suggests that this weight management intervention is safe?

Research has shown that mobile health (mHealth) tools for managing weight are popular with users. Although specific safety data on these apps is limited, they are generally considered safe and helpful. Studies have found high user satisfaction, indicating effective user engagement with these tools.

When combined with support from Community Health Workers (CHWs), mHealth remains promising. While specific safety data on this combination is limited, CHW support is seen as a positive addition. It encourages healthy habits, particularly in communities with fewer resources.

Overall, both mHealth alone and mHealth with CHW support are regarded as safe and acceptable methods for weight management. They focus on promoting healthy lifestyle changes, and no major safety issues have been reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer a fresh approach to managing obesity through digital health tools. Unlike traditional methods like diet plans or medications, the mHealth treatment uses a 12-month text messaging program to set and achieve diet and exercise goals, making it accessible and engaging. The mHealth+CHW support takes it a step further by adding personalized monthly phone counseling from a Community Health Worker, providing a unique blend of digital and human support. This integration of technology and personal interaction could potentially enhance motivation and adherence to healthy habits, which is why researchers are eager to see its impact.

What evidence suggests that this trial's treatments could be effective for obesity?

Research has shown that mobile health (mHealth) apps can aid in weight loss. In one study, 42.20% of app users lost at least 5% of their body weight over a year. Another study found that users of mHealth apps experienced noticeable weight loss after six months. In this trial, one group will receive a 12-month text messaging program about diet and physical activity behavioral goals as part of the mHealth intervention.

Another group will receive the same mHealth program plus additional support from a Community Health Worker (CHW) through monthly behavioral phone counseling. Although specific data on using mHealth apps with CHW support is limited, other research has indicated that CHW-led programs can effectively help low-income communities manage their weight. This suggests that combining both methods might be even more successful in promoting weight loss. ^{3 6 7 8 9}

Who Is on the Research Team?

Ziming Xuan, ScD

Principal Investigator

BU School of Public Health, Community Health Services

Lisa Quintiliani, PhD

Principal Investigator

Tufts Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11091450/

The effectiveness of mobile app usage in facilitating weight ... This study found that 42.20% (95%CI: 42.95, 45.44) of active users lost ≥5% of their body weight at 52 weeks follow‐up. While the current study did not ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8735823/

Effectiveness of Mobile Health Applications for 5% Body ... This study verifies the significant effects of a popular mHealth app on 5% body weight reduction in overweight and obese adults for a study period of 6 months.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2589537023004868

Effectiveness of holistic mobile health interventions on diet ... In the meta-analysis, holistic mHealth interventions were associated with significant weight loss (9 RCTs; mean difference −1.70 kg, 95% CI −2.45 to −0.95; I2 = ...

4. jmir.org jmir.org/2025/1/e66887

The Role of Mobile Apps in Obesity Management Smartphone apps demonstrate a modest but statistically significant effect on weight loss and BMI reduction over a 4- to 6-month period in individuals with ...

5. jphe.amegroups.org jphe.amegroups.org/article/view/8623/html

The evolution and effects of mobile health (mHealth ... The intelligent interventions appeared to be more effective in weight loss, especially in reducing BW (−2.66 vs. −1.84 kg), WC (−2.31 vs. −2.17 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6913727/

Assessment of the Efficacy, Safety, and Effectiveness of ... The aim of this study was to identify efficacy, safety, and effectiveness criteria used to assess weight control, overweight, and obesity management in mobile ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10809169/

The Association of eHealth Literacy Skills and mHealth ... The purpose of this study was to explore the associations between the 2 dimensions, access and application, of eHealth literacy skills and mHealth app use ...

8. withpower.com withpower.com/trial/phase-obesity-2023-f4342

Mobile Health App for Weight Management in Obesity The research does not provide specific safety data for the Mobile Health App for Weight Management, but it highlights user satisfaction and the app's usefulness ...

9. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-021-11618-7

Mobile health assisted self-monitoring is acceptable for ... Self-monitoring of physical activity, weight, and dietary intake is positively associated with weight loss [9]. Smartphone applications (apps) ...