Mobile Health Technology for Weight Loss in Bone Marrow Transplant Patients

Overseen By Andres Vargas

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Age, BMI, Post-transplant days, others

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

Compensation: Varies

Number of Visits: 3

Duration: 16 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a mobile health app, W8L2G, designed to aid weight loss in patients who have undergone a bone marrow transplant (HSCT). The app addresses addictive eating habits and boosts motivation through coaching over four months. It is especially suited for those struggling with obesity after their transplant. Eligible participants include teens and young adults, aged 13 to 30, who are at least 100 days post-transplant and can read English. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve post-transplant care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the W8L2G mobile health app is safe for weight loss in bone marrow transplant patients?

Research has shown that mobile health (mHealth) apps, such as the W8L2G app, are generally safe for users. These apps have been used in studies to help people manage their weight and encourage healthy habits. For instance, one study on a similar weight management app found that users liked it, and no serious side effects were reported.

Weight loss apps typically focus on tracking habits and offering guidance. This method is considered safe because it involves changing behaviors rather than using medications or undergoing medical procedures. The W8L2G app follows this approach by providing support and motivation for making healthier choices.

While this pilot study is still examining the app's effectiveness, previous research has shown promise in using apps for weight management. No negative effects have been reported in the sources, suggesting the app is likely well-tolerated. However, since this is a new area of study, participants should report any problems they experience while using the app. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional weight loss methods for bone marrow transplant patients, which often involve diet and exercise programs or medications, the W8L2G mobile health app offers a unique approach through technology. This app uses an addiction model-based intervention combined with personalized coaching over a mobile platform, making it highly accessible and convenient. Researchers are excited because this method not only provides continuous support but also harnesses the power of digital health to potentially offer more engaging and tailored weight loss strategies.

What evidence suggests that the W8L2G mobile health app is effective for weight loss in bone marrow transplant patients?

Research shows that mobile health apps can help people lose weight. Studies have found these apps to be a cost-effective and accessible alternative to traditional weight loss programs. In this trial, participants will use the W8L2G mobile health app, which shows promise for managing weight, particularly for groups like bone marrow transplant patients. The app is tested using an addiction model that focuses on changing behaviors, making it potentially helpful for those with addictive eating habits. Overall, mobile health technology appears promising for supporting weight loss in challenging medical situations. ^{1 5 6 7 8}

Who Is on the Research Team?

Theodore B Moore, MD

Principal Investigator

UCLA Health

Are You a Good Fit for This Trial?

This trial is for English-reading individuals aged 13 to 30 who are considered obese (BMI ≥85th percentile) and have had any type of hematopoietic stem cell transplant at least 100 days before starting the study.

Inclusion Criteria

I am between 13 and 30 years old and had a stem cell transplant over 100 days ago.

I am either male or female.

My BMI is in the top 15% for my age and gender, classifying me as obese.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an addiction model based mobile health (mHealth) weight loss intervention with coaching

16 weeks

3 visits (in-person), weekly phone calls, daily weekday texts

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• W8L2G mobile health (mHealth) app

Trial Overview The study tests a mobile health app called W8L2G, designed to help post-transplant patients lose weight. It will measure changes in body mass index, metabolic rates, eating behaviors, and motivation levels.

How Is the Trial Designed?

Group I: App Group Experimental Treatment 1 Intervention

Participants will be receiving an addiction model based mobile health (mHealth) weight loss intervention with coaching for a total of 4 months duration

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Published Research Related to This Trial

Hematopoietic stem cell transplant (HSCT) can be a curative treatment for blood cancers, but it often leads to decreased quality of life and performance status in patients.

The use of wearable technologies may help overcome barriers to exercise, making it easier for HSCT patients to participate in exercise therapy, which has been shown to improve their outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable Monitors Facilitate Exercise in Adult and Pediatric Stem Cell Transplant. Pottebaum, E., Warmoth, A., Ayyappan, S., et al.[2023]

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 pilot study involving 50 obese black women tested a 6-month text messaging intervention for weight loss, showing that participants in the intervention group lost an average of 1.27 kg, while the control group gained weight, indicating potential efficacy of the text messaging approach.

The study found that 85% of participants engaged with the self-monitoring prompts at least twice a week, and many reported that the daily texting was easy and helpful, suggesting that text messaging could be a feasible tool for weight management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily text messaging for weight control among racial and ethnic minority women: randomized controlled pilot study. Steinberg, DM., Levine, EL., Askew, S., et al.[2021]

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]

A feasibility study involving 20 obese adolescents showed that tailored SMS messages about weight-related behaviors can effectively enhance adherence to a weight-management program.

Participants found the messages, especially meal suggestions and recipes, personally relevant and enjoyable, indicating that computerized tailored messaging is a promising tool for supporting healthy lifestyle changes in adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tailored mobile phone text messages as an adjunct to obesity treatment for adolescents. Woolford, SJ., Clark, SJ., Strecher, VJ., et al.[2021]

The LEAP Beep text messaging intervention significantly helped overweight and obese adults maintain weight loss, with participants losing an average of 1.6 kg compared to only 0.7 kg in the control group over 12 weeks.

Participants in the text messaging group also showed improvements in waist circumference and BMI, along with better follow-up attendance, indicating that real-time support through text messages can enhance weight management efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A text message based weight management intervention for overweight adults. Donaldson, EL., Fallows, S., Morris, M.[2014]

Mobile health (mHealth) diet interventions significantly improved dietary habits in cancer survivors, increasing fruit and vegetable intake and reducing fat intake, while also leading to weight loss and reductions in waist and hip circumference, based on a review of 15 randomized controlled trials involving 2363 participants.

These interventions also positively impacted the quality of life for cancer survivors, indicating that mHealth strategies could be an effective approach for dietary management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of mHealth diet interventions in cancer survivors: A systematic review and meta-analysis of randomized controlled trials. Gong, Y., Jiang, X., Chen, X., et al.[2023]

In a 3-month randomized controlled trial involving adults with colorectal polyps, participants using a smartphone application for weight loss achieved a significant weight reduction of -1.25 kg compared to -0.42 kg in the control group.

The smartphone application also led to a notable increase in physical activity, with users engaging in an average of 1.57 strenuous exercises per week, compared to 0.71 in the control group, suggesting that such apps can effectively promote healthier behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in Weight and Health-Related Behavior Using Smartphone Applications in Patients With Colorectal Polyps. Lee, KW., Kim, HB., Lee, SH., et al.[2020]

The TRU-BMT mHealth app was developed to help hematopoietic stem cell transplantation (HCT) patients monitor their health daily, aiming to improve symptom tracking and early detection of complications, with a pilot study involving 30 patients over 180 days.

Adherence to the app was around 30% daily and 44% weekly, and higher adherence correlated with better health outcomes, such as increased meal completion and shorter hospital stays, indicating the app's potential to enhance patient management during HCT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the Feasibility of a Novel mHealth App in Hematopoietic Stem Cell Transplant Patients. Racioppi, A., Dalton, T., Ramalingam, S., et al.[2023]

A pilot study involving 41 hematologic malignancy survivors showed that a 16-week mHealth-supported intervention, which included individualized goal-setting and peer support via Facebook, was feasible and well-accepted, with a high participant retention rate of 90.2%.

While the intervention did not yield statistically significant differences in activity or dietary outcomes compared to the control group, it was associated with improvements in dietary factors and physical activity levels, indicating potential benefits for cardiovascular risk reduction in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a behavioral intervention using mobile health applications to reduce cardiovascular risk factors in cancer survivors: a pilot randomized controlled trial. Chow, EJ., Doody, DR., Di, C., et al.[2022]

The MY-Medula mHealth platform was successfully implemented in a pilot study with 28 allogeneic stem cell transplantation (allo-SCT) recipients, showing high usability with a median of 143 app visits per patient over 2 months.

Patients and healthcare professionals reported high satisfaction rates (95% and 100%, respectively) with the integrated care model, indicating that mHealth tools can enhance follow-up care for allo-SCT recipients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a New Model of Care for Allogeneic Stem Cell Transplantation Recipients Facilitated by eHealth: The MY-Medula Pilot Study. Redondo, S., De Dios, A., Gomis-Pastor, M., et al.[2023]

Citations

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Behavioral Weight Loss Intervention Utilizing Mobile Health ... This is a pilot study enrolling obese patients, age 13-30, in an addiction model based smartphone mobile health (mHealth) weight loss intervention with coaching ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10522407/

Assessing the Feasibility of a Novel mHealth App in ... Our findings suggest that using TRU-BMT throughout HCT transplant is feasible for patients and established a proof-of-concept for a future randomized control ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10034244/

The Efficacy of Mobile Applications for Weight Loss - PMC Mobile apps can successfully help patients lose weight and represent a cost-effective, accessible alternative to intensive in-person weight loss programs.

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See if an iPhone Weight Management App Can Help Promote ... A Study to See if an iPhone Weight Management App Can Help Promote Weight Loss in Adolescents and Young Adults After a Stem Cell Transplant.

5. mhealth.jmir.org mhealth.jmir.org/2019/10/e15775/

A Mobile Health App (Roadmap 2.0) for Patients Undergoing ... Our primary dataset included semistructured interviews with the primary caregivers of hematopoietic stem cell transplant patients (ie, provided ...

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Behavioral Weight Loss Intervention Utilizing Mobile ... This is a pilot study enrolling obese patients, age 13-30, in an addiction model based smartphone mobile health (mHealth) weight loss ...

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Use of Mobile Phone App Interventions to Promote Weight Loss The main objective of this study was to assess the efficacy of a mobile phone app intervention for reducing body weight and increasing physical activity among ...

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The role of mobile health applications (mHealth apps) in ... This study aimed to investigate the role of mobile health applications in reducing weight among users in Riyadh, Saudi Arabia.