Smartphone Weight Loss Coaching for Post-Transplant Weight Loss

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Jonsson Comprehensive Cancer Center

Disqualifiers: Less than 100 days post-transplant, BMI not obese

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 14

Duration: 4 months

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively a weight loss program using a smartphone app and coaching helps adolescents and young adults lose weight after a stem cell transplant. Participants will use the iPhone Weight Management App to track their weight and food intake, receiving support from coaches through texts and phone calls. The trial seeks individuals who are at least 100 days post-transplant, can read English, and are considered obese (with a body mass index at or above the 85th percentile for their age and gender). As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance future weight management strategies.

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 this smartphone weight management application is safe for post-transplant weight loss?

Research shows that mobile phone apps, such as the iPhone Weight Management App, can aid in weight loss. They offer a safe and user-friendly alternative to more intense weight loss programs. Although specific safety data for this app is unavailable, weight loss apps are generally well-received and pose low risk.

The app in this study combines a digital platform with coaching. This method is not known to cause harm and is generally considered safe for users. While direct safety data for this app is lacking, mobile apps for weight loss have not been associated with major negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Smartphone Weight Loss Coaching program because it leverages technology to provide personalized support for post-transplant weight management. Unlike traditional weight loss programs that might rely solely on in-person visits or generic dietary plans, this approach uses an iPhone app to offer real-time coaching and feedback. The program includes daily self-monitoring with digital scales and regular interaction with coaches via text and phone, making it highly adaptive and supportive. This method aims to address emotional and behavioral barriers to weight loss, which are often overlooked in standard treatments, potentially offering a more comprehensive and effective solution.

What evidence suggests that this smartphone weight management app is effective for post-transplant weight loss?

Research has shown that smartphone apps can aid in weight loss, especially when combined with coaching. A review of 34 studies found that 71% reported positive weight loss results when people used apps for 3 to 6 months. In this trial, participants will use an iPhone app with coaching to manage their weight after a stem cell transplant. The app and coaching aim to build healthy habits and provide emotional support. Early results suggest this method can help people lose weight and improve their eating habits. ^{1 2 3 4 6}

Who Is on the Research Team?

Theodore Moore, MD

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Supportive Care (app, scales, coaching, questionnaire) Experimental Treatment 6 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

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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 study involving 22 participants from a weight management clinic in Singapore identified key features that weight loss apps should include for a multi-ethnic population with overweight and obesity, such as comprehensive calorie counters and individualized behavior change recommendations.

Participants emphasized the importance of flexibility in food logging and the need for apps to provide just-in-time reminders about the consequences of their choices, suggesting that future apps could benefit from artificial intelligence to offer personalized support for weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Essential elements of weight loss apps for a multi-ethnic population with high BMI: a qualitative study with practical recommendations. Chew, HSJ., Lim, SL., Kim, G., et al.[2023]

A new app evaluation tool called Ped-WHAT was developed to assess smartphone applications for childhood obesity management based on evidence-based behavior modification strategies and American Academy of Pediatrics guidelines.

After training healthcare providers on how to use the Ped-WHAT tool, there were significant improvements in their knowledge and confidence in using these apps, highlighting the importance of provider education in effectively managing childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity Applications in Smartphones: Development and Use of an Evaluation Tool. Al-Lami, N., Sear, K., Dai, W., et al.[2021]

A review of 28 smartphone apps related to weight loss surgery revealed that 92.9% are designed for patient use, but only 42.9% involved health professionals in their development, raising concerns about the reliability of the information provided.

The study suggests that implementing a 'quality stamp' from a recognized bariatric surgical body could enhance the credibility of these apps, ensuring patients receive accurate information as part of their informed consent process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity surgery smartphone apps: a review. Stevens, DJ., Jackson, JA., Howes, N., et al.[2021]

In a 12-week study involving 112 overweight Japanese adults, those receiving professional dietary coaching via a smartphone app lost significantly more weight (average -1.4 kg) compared to the control group (-0.1 kg).

Participants who frequently uploaded meal photos to the group chat not only lost more weight but also showed significant improvements in cardiometabolic risk factors, indicating that active engagement in the program enhances health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Professional dietary coaching within a group chat using a smartphone application for weight loss: a randomized controlled trial. Tanaka, K., Sasai, H., Wakaba, K., et al.[2022]

A randomized controlled trial involving 212 primary care patients found that introducing the MyFitnessPal app for weight loss did not lead to significant weight loss differences after 6 months compared to usual care, with a mean difference of only -0.30 kg.

While users of the app reported high satisfaction and increased frequency of setting personal calorie goals, overall weight change and systolic blood pressure did not improve significantly, suggesting that simply providing a smartphone app may not be enough to drive substantial weight loss for most patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a smartphone application for weight loss compared with usual care in overweight primary care patients: a randomized, controlled trial. Laing, BY., Mangione, CM., Tseng, CH., et al.[2022]

In a study of 104 overweight or obese Korean adults using the Noom app for 15 weeks, participants achieved a significant weight loss of -7.5%, which was maintained at -5.2% after 52 weeks, indicating the app's effectiveness for long-term weight management.

The intervention also led to notable improvements in body composition, with reductions in body fat and visceral fat, as well as significant decreases in fasting glucose levels, highlighting the app's potential benefits beyond just weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Smartphone Application for the Management of Metabolic Syndrome Components Focusing on Weight Loss: A Preliminary Study. Toro-Ramos, T., Lee, DH., Kim, Y., et al.[2022]

The study identified 28,905 weight-management apps across various platforms, highlighting the popularity of mobile health (mHealth) solutions for addressing overweight and obesity, with a focus on physical activity (34%) and diet (31%).

Despite the abundance of these apps, only 17 (0.05%) included identifiable professional input from dietitians or nutritionists, indicating a significant gap in expert content that could enhance their effectiveness and safety for users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile applications for obesity and weight management: current market characteristics. Nikolaou, CK., Lean, ME.[2018]

In a study involving 32 kidney transplant recipients, a digital healthcare intervention (DHI) aimed at preventing weight gain was found to be feasible and acceptable, with 76.4% retention over 12 months and no adverse events reported.

Participants expressed a strong interest in the intervention, indicating a need for structured support in managing weight post-transplant, which supports the case for a larger randomized controlled trial to further evaluate the DHI's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Feasibility and User-Experience of a Digital Health Intervention Designed to Prevent Weight Gain in New Kidney Transplant Recipients-The ExeRTiOn2 Trial. Castle, EM., Dijk, G., Asgari, E., et al.[2022]

Citations

1. uclahealth.org uclahealth.org/clinical-trials/study-see-if-iphone-weight-management-app-can-help-promote

A Study to See if an iPhone Weight Management App Can ... This early phase I trial studies how well a behavioral weight loss intervention consisting of a smartphone application and coaching works for the promotion ...

2. trial.medpath.com trial.medpath.com/clinical-trial/b3ef16ca66e7ddc0/nct04453072-study-iphone-app-weight-loss

A Study to See if an iPhone Weight Management App Can ... 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. Not Applicable.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04453072/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

A Study to See if an iPhone Weight Management App Can ... This early phase I trial studies how well a behavioral weight loss intervention consisting of a smartphone application and coaching works ...

4. withpower.com withpower.com/trial/phase-weight-loss-6-2020-1fb90

Smartphone Weight Loss Coaching for Post-Transplant ... Trial Overview The study tests a weight management program using an iPhone app with coaching to help participants lose weight after stem cell transplantation.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9034427/

The Effectiveness of Combining Nonmobile Interventions ... Of the 34 included studies, 24 (71%) examined the effectiveness of smartphone apps on weight loss at 3 and 6 months, whereas 5 (15%) measured the outcomes at 12 ...

6. 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.