20 Participants Needed

Smartphone Weight Loss Coaching for Post-Transplant Weight Loss

Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Jonsson Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

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 smartphone weight management app treatment for post-transplant weight loss?

Research shows that smartphone apps for weight loss are popular because they allow users to track their diet and exercise, provide feedback, and help set goals. These features can motivate and educate users, making them a potentially effective tool for managing weight.12345

Is the Smartphone Weight Loss Coaching app safe for humans?

There is no specific safety data available for the Smartphone Weight Loss Coaching app, but generally, weight management apps are widely used and considered safe as they focus on self-monitoring diet and physical activity. However, most apps lack professional content expertise, so it's important to choose apps developed with professional input.16789

How is the iPhone Weight Management App treatment different from other weight loss treatments?

The iPhone Weight Management App is unique because it offers a convenient, potentially cost-effective way to manage weight through a smartphone, focusing on self-monitoring of diet and physical activity, and includes elements like personalization and feedback, which are not typically emphasized in traditional weight loss treatments.1361011

What is the purpose of this trial?

This early phase I trial studies how well a behavioral weight loss intervention consisting of a smartphone application and coaching works for the promotion of weight loss in adolescents and young adults after a stem cell transplant. This study may help researchers learn more about how adolescents and young adults can lose weight and develop healthy eating habits.

Research Team

Theodore B. Moore, MD - Pediatric ...

Theodore Moore, MD

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Eligibility Criteria

This trial is for adolescents and young adults who had a stem cell transplant at least 100 days ago, are obese (BMI >= 85th percentile), can speak and read English. Parents can enroll if their child meets these criteria. No exclusions based on medical conditions, but participation may be limited if health significantly affects intervention engagement.

Inclusion Criteria

PARENT: His/her child meets all inclusion criteria
My BMI is in the top 15% for my age and gender.
You will not be excluded based on any medical condition. However, if your medical condition is deemed to significantly interfere with your ability to participate in the study, a decision will be made on a case-by-case basis.
See 2 more

Exclusion Criteria

My BMI is not in the obese range.
Patients who are < 100 days post-transplant at initial consultation will not be eligible for the study, but may become eligible if they are > 100 days post-transplant at their next consultation that falls within the enrollment window

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a smartphone application and coaching for weight management, including daily interactions and weekly phone calls

4 months
Weekly phone calls, daily text interactions, telemedicine interviews at 2 and 4 months

Follow-up

Participants are monitored for changes in metabolic parameters, physical activity, and eating behaviors

8 months
Telemedicine meeting at month 12 for those extending the intervention

Open-label extension (optional)

Participants may opt to extend the intervention until month 12 with additional telemedicine meetings

4 months

Treatment Details

Interventions

  • iPhone Weight Management App
Trial Overview The study tests a weight management program using an iPhone app with coaching to help participants lose weight after stem cell transplantation. It aims to see how well the app promotes weight loss and helps develop healthy eating habits in young patients.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Supportive Care (app, scales, coaching, questionnaire)Experimental Treatment6 Interventions
Patients receive an iPhone with W8Loss2Go app, a body scale and a digital food scale to weigh themselves and food daily. Patients interact with coaches via text messages for 4 days weekly and receive weekly 15 minute phone calls for appointment reminders, emotional support, progress discussion, and follow up on items discussed in a prior visit or phone call. Patients also have telemedicine interviews with the coach lasting 60 minutes at 2 and 4 months to elicit both positive and negative impacts on weight management and to identify barriers such as emotional eating, displacement behaviors, poor coping skills to life stressors, and social challenges. Patients who opt to extend the intervention until month 12 attend an additional telemedicine meeting with the coach. Patients also complete questionnaires over approximately 1.5 hours.

iPhone Weight Management App is already approved in United States for the following indications:

🇺🇸
Approved in United States as iPhone Weight Management App for:
  • Weight loss in adolescents and young adults after a stem cell transplant

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials
373
Recruited
35,200+

eHealth International, INC.

Collaborator

Trials
2
Recruited
70+

Findings from Research

The smartphone app My Meal Mate (MMM) showed significantly higher adherence to dietary recording (92 days on average) compared to a website (35 days) and paper diary (29 days), indicating it may be a more effective tool for self-monitoring in weight management.
Participants using the MMM app lost an average of 4.6 kg over 6 months, which was more than the weight loss observed in the website (2.9 kg) and diary (1.3 kg) groups, suggesting that the app is an effective intervention for weight loss.
Adherence to a smartphone application for weight loss compared to website and paper diary: pilot randomized controlled trial.Carter, MC., Burley, VJ., Nykjaer, C., et al.[2023]
A prototype mobile health (mHealth) system for kidney transplant patients significantly improved medication adherence and reduced systolic blood pressure compared to standard care, demonstrating its potential effectiveness in managing hypertension.
The system was found to be safe and highly acceptable among patients and providers, with a high retention rate of 91% during the 3-month trial involving 20 participants, indicating strong feasibility for future larger studies.
Mobile Health Medication Adherence and Blood Pressure Control in Renal Transplant Recipients: A Proof-of-Concept Randomized Controlled Trial.McGillicuddy, JW., Gregoski, MJ., Weiland, AK., 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.
Consumer perspectives on mHealth for weight loss: a review of qualitative studies.Lyzwinski, LN., Caffery, LJ., Bambling, M., et al.[2018]

References

Adherence to a smartphone application for weight loss compared to website and paper diary: pilot randomized controlled trial. [2023]
Mobile Health Medication Adherence and Blood Pressure Control in Renal Transplant Recipients: A Proof-of-Concept Randomized Controlled Trial. [2022]
Consumer perspectives on mHealth for weight loss: a review of qualitative studies. [2018]
Obesity Applications in Smartphones: Development and Use of an Evaluation Tool. [2021]
The Feasibility and User-Experience of a Digital Health Intervention Designed to Prevent Weight Gain in New Kidney Transplant Recipients-The ExeRTiOn2 Trial. [2022]
Obesity surgery smartphone apps: a review. [2021]
Mobile applications for obesity and weight management: current market characteristics. [2018]
Effectiveness of a smartphone application for weight loss compared with usual care in overweight primary care patients: a randomized, controlled trial. [2022]
Essential elements of weight loss apps for a multi-ethnic population with high BMI: a qualitative study with practical recommendations. [2023]
Professional dietary coaching within a group chat using a smartphone application for weight loss: a randomized controlled trial. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Effectiveness of a Smartphone Application for the Management of Metabolic Syndrome Components Focusing on Weight Loss: A Preliminary Study. [2022]
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