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

Trial Summary

What is the purpose of this trial?

Pilot study enrolling obese post HSCT (hematopoietic stem cell transplantation) patients at the hematology/oncology clinic at the Mattel Children's Hospital, University of California, Los Angeles. Parameters include percent over the 95th percentile (%BMIp95), zBMI, fasting metabolic metrics, addictive eating habits, and motivation for change.

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 data supports the effectiveness of the W8L2G mobile health app treatment for weight loss in bone marrow transplant patients?

Research shows that mobile health apps can help improve diet and physical activity in cancer survivors, and wearable technologies can encourage exercise in stem cell transplant patients. These findings suggest that similar mobile health tools, like the W8L2G app, could be effective in supporting weight loss and health improvements in bone marrow transplant patients. ^{1 2 3 4 5}

Is the W8L2G mobile health app safe for use in humans?

The research on mobile health apps for weight loss, including text messaging interventions, suggests they are generally safe and well-received by users, with no significant safety concerns reported in the studies reviewed. ^{6 7 8 9 10}

How is the W8L2G mobile health app treatment different from other treatments for weight loss in bone marrow transplant patients?

The W8L2G mobile health app is unique because it uses technology to monitor and support weight loss and health behavior changes in bone marrow transplant patients, allowing for real-time tracking and potentially earlier intervention compared to traditional methods. ^{1 3 4 5 11}

Research Team

Theodore B Moore, MD

Principal Investigator

UCLA Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2022]

2. United States 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. [2023]

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

Assessing the Feasibility of a Novel mHealth App in Hematopoietic Stem Cell Transplant Patients. [2023]

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

Wearable Monitors Facilitate Exercise in Adult and Pediatric Stem Cell Transplant. [2023]

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

Effectiveness of mHealth diet interventions in cancer survivors: A systematic review and meta-analysis of randomized controlled trials. [2023]

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

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

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

A text message based weight management intervention for overweight adults. [2014]

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

Daily text messaging for weight control among racial and ethnic minority women: randomized controlled pilot study. [2021]

9. England pubmed.ncbi.nlm.nih.gov

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

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

Tailored mobile phone text messages as an adjunct to obesity treatment for adolescents. [2021]

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

Changes in Weight and Health-Related Behavior Using Smartphone Applications in Patients With Colorectal Polyps. [2020]