Smartphone Weight Loss Coaching for Post-Transplant Weight Loss
Recruiting in Palo Alto (17 mi)
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Jonsson Comprehensive Cancer Center
Disqualifiers: Less than 100 days post-transplant, BMI not obese
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
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.
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.
12345Is 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.
16789How 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.
1361011Eligibility 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
Can speak English
My BMI is in the top 15% for my age and gender.
+4 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
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
UCLA / Jonsson Comprehensive Cancer CenterLos Angeles, CA
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Who Is Running the Clinical Trial?
Jonsson Comprehensive Cancer CenterLead Sponsor
eHealth International, INC.Collaborator
References
Adherence to a smartphone application for weight loss compared to website and paper diary: pilot randomized controlled trial. [2023]There is growing interest in the use of information communication technologies to treat obesity. An intervention delivered by smartphone could be a convenient, potentially cost-effective, and wide-reaching weight management strategy. Although there have been studies of texting-based interventions and smartphone applications (apps) used as adjuncts to other treatments, there are currently no randomized controlled trials (RCT) of a stand-alone smartphone application for weight loss that focuses primarily on self-monitoring of diet and physical activity.
Mobile Health Medication Adherence and Blood Pressure Control in Renal Transplant Recipients: A Proof-of-Concept Randomized Controlled Trial. [2022]Mobile phone based programs for kidney transplant recipients are promising tools for improving long-term graft outcomes and better managing comorbidities (eg, hypertension, diabetes). These tools provide an easy to use self-management framework allowing optimal medication adherence that is guided by the patients' physiological data. This technology is also relatively inexpensive, has an intuitive interface, and provides the capability for real-time personalized feedback to help motivate patient self-efficacy. Automated summary reports of patients' adherence and blood pressure can easily be uploaded to providers' networks helping reduce clinical inertia by reducing regimen alteration time.
Consumer perspectives on mHealth for weight loss: a review of qualitative studies. [2018]Introduction With increasing development and use of mobile health (mHealth) interventions for weight loss in overweight and obese populations, it is timely to gain greater insight into consumer experience with these technologies. The aims of this review were to identify common themes across studies that included user preferences for mHealth intervention for weight loss. Methods The databases PubMed (Medline), CINAHL, Web of Science, and Embase were searched for relevant qualitative studies on mHealth for weight loss. Searches were conducted in May 2016. Results Several common high preference themes were identified relating to simple and attractive apps that allowed for self-monitoring with feedback. The five key themes concerning text messages for weight loss involved a careful consideration of personalization, message tone, structure, frequency and content. Key optimization themes for weight loss apps were personalization, simplicity with appeal and engagement/entertainment. Common identified benefits of mHealth for weight loss included self-monitoring, goal setting, feedback, ability to motivate, educate, and remind. Common barriers users identified were related to technological and psychological issues as well as message overload/inappropriate timing of messages. Conclusion When planning an mHealth weight loss intervention, critical factors are the message tone, structure and the frequency of message delivery. Personalization also seems to be important. Designing simple apps while still ensuring that they engage the user is also essential. Additionally, it seems important to tailor the content in accordance with different target group demographic preferences. The successful reach and adoption of mHealth interventions requires minimizing perceived barriers and maximizing perceived benefits.
Obesity Applications in Smartphones: Development and Use of an Evaluation Tool. [2021]Rates of obesity amongst children and teens in the United States have tripled since the 1970s, and 18.5% are now considered obese. With smartphone use among children and teens becoming the norm, smartphone applications may be a cost-effective solution to support patients and families motivated to change lifestyle behaviors and reduce obesity. The purpose of this quality-improvement project was (1) to develop an app evaluation tool and star rating system based on scientific evidence and current clinical practice guidelines in managing childhood obesity, and (2) to determine whether an in-service training can increase provider knowledge and efficacy in the use of smartphone apps in managing childhood obesity.
The Feasibility and User-Experience of a Digital Health Intervention Designed to Prevent Weight Gain in New Kidney Transplant Recipients-The ExeRTiOn2 Trial. [2022]Half of kidney transplant recipients (KTRs) gain more than 5% of their body weight in the first year following transplantation. KTRs have requested support with physical activity (PA) and weight gain prevention, but there is no routine care offered. There are few high-quality studies investigating the clinical value of diet, PA or combined interventions to prevent weight gain. The development and evaluation of theoretically informed complex-interventions to mitigate weight gain are warranted. The aims of this mixed-methods randomized controlled trial (RCT) were to explore the feasibility, acceptability and user-experience of a digital healthcare intervention (DHI) designed to prevent post-transplant weight gain, in preparation for a large multi-center trial. New KTRs (<3 months) with access to an internet compatible device were recruited from a London transplant center. The usual care (UC) group received standard dietary and PA advice. The intervention group (IG) received access to a 12-week DHI designed to prevent post-transplant weight gain. Primary feasibility outcomes included screening, recruitment, retention, adherence, safety and hospitalizations and engagement and experience with the DHI. Secondary outcomes (anthropometrics, bioimpedance, arterial stiffness, 6-minute walk distance and questionnaires) were measured at baseline, 3- and 12-months. 38 KTRs were screened, of which 32 (84.2%) were eligible, and of those 20 (62.5%) consented, with 17 participants (85%) completing baseline assessment (Median 49 years, 58.8% male, Median 62 days post-transplant). Participants were randomized using a computer-generated list (n = 9 IG, n = 8 UC). Retention at 12-months was 13 (76.4%) (n = 6 IG, n = 7 UC). All a priori progression criteria were achieved. There were no associated adverse events. Reflexive thematic analysis revealed four themes regarding trial participation and experience whilst using the DHI. Halting recruitment due to COVID-19 resulted in the recruitment of 40% of the target sample size. Mixed-methods data provided important insights for future trial design. A definitive RCT is warranted and welcomed by KTRs.
Obesity surgery smartphone apps: a review. [2021]The purpose of this study are to review available smartphone applications ('apps') relating to weight loss surgery, and assess the level of medical professional involvement in their design
Mobile applications for obesity and weight management: current market characteristics. [2018]Mobile-Health (mHealth) is the fastest-developing eHealth sector, with over 100 000 health applications (apps) currently available. Overweight/obesity is a problem of wide public concern that is potentially treatable/preventable through mHealth. This study describes the current weight-management app-market. Five app stores (Apple, Google, Amazon, Windows and Blackberry) in UK, US, Russia, Japan and Germany, Italy, France, China, Australia and Canada were searched for keywords: 'weight', 'calorie', 'weight-loss', 'slimming', 'diet', 'dietitian' and 'overweight' in January/February 2016 using App-Annie software. The 10 most downloaded apps in the lifetime of an app were recorded. Developers' lists and the app descriptions were searched to identify any professional input with keywords 'professional', 'dietitian' and 'nutritionist'. A total of 28 905 relevant apps were identified as follows: Apple iTunes=8559 (4634, 54% paid), Google Play=1762 (597, 33.9% paid), Amazon App=13569 (4821, 35.5% paid), Windows=2419 (819, 17% paid) and Blackberry=2596 (940, 36% paid). The 28 905 identified apps focused mainly on physical activity (34%), diet (31%), and recording/monitoring of exercise, calorie intake and body weight (23%). Only 17 apps (0.05%) were developed with identifiable professional input. Apps on weight management are widely available and very popular but currently lack professional content expertise. Encouraging app development based on evidence-based online approaches would assure content quality, allowing healthcare professionals to recommend their use.
Effectiveness of a smartphone application for weight loss compared with usual care in overweight primary care patients: a randomized, controlled trial. [2022]Many smartphone applications (apps) for weight loss are available, but little is known about their effectiveness.
Essential elements of weight loss apps for a multi-ethnic population with high BMI: a qualitative study with practical recommendations. [2023]Smartphone weight loss apps are constantly being developed but the essential elements needed by a multi-ethnic population with overweight and obesity remains unclear. Purpose: To explore the perceptions of an Asian multi-ethnic population with overweight and obesity on the essential elements of weight loss apps. Twenty two participants were purposively sampled from a specialist weight management clinic in Singapore from 13 April to 30 April 2021. Recorded interviews were conducted using face-to-face and videoconferencing modalities. Data saturation was reached at the 18th participant. Data analysis was performed using inductive content analysis with constant comparison between and within transcripts. Findings: Three themes and eight subthemes on the essential app components emerged-(a) comprehensive and flexible calorie counters; (b) holistic, gradual and individualized behavior change recommendations tailored for people with overweight and obesity, and (c) just-in-time reminders of future consequences. There was a need to incorporate flexible options for food logging; break down general recommendations into small steps towards sustainable changes; tailor app contents for people with overweight and obesity; and evoke one's considerations of future consequences. Future weight loss apps should be designed to meet the needs of those with overweight and obesity, the very population that needs assistance with weight loss. Future apps could consider leveraging the capacity of artificial intelligence to provide personalized weight management in terms of sustaining self-regulation behaviors, optimizing goal-setting and providing personalized and timely recommendations for weight loss.
Professional dietary coaching within a group chat using a smartphone application for weight loss: a randomized controlled trial. [2022]To test the effectiveness of professional dietary coaching via group chat using a smartphone application (app) for weight loss.
Effectiveness of a Smartphone Application for the Management of Metabolic Syndrome Components Focusing on Weight Loss: A Preliminary Study. [2022]There are inconsistent results for the effectiveness of using smartphone applications (apps) or websites on weight loss. We investigated the efficacy of a smartphone intervention using a designated app that utilizes a lifestyle intervention-focused approach, including a human coaching element, toward weight loss in overweight or obese Korean adults.