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

Study Overview
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Brief Summary
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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.

Detailed Description
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PRIMARY OBJECTIVE: I. To evaluate the effectiveness of an addiction-based weight loss intervention, embodied as a smartphone application (app) with telephone coaching, on weight outcomes of overweight and obese post hematopoietic stem cell transplantation (HSCT) adolescents and young adults. SECONDARY OBJECTIVES: I. To evaluate the changes in metabolic parameters and physical activity levels, in addition to modifications in addictive eating behaviors, motivation, and self-regulatory behaviors. II. To evaluate the feasibility, adherence, and satisfaction of this intervention. OUTLINE: 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.

Official Title
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Behavioral Weight Loss Intervention Utilizing Mobile Health Technology in Hematopoietic Stem Cell Transplant Patients (BWL001)

Conditions
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Obesity, Malignant Neoplasm

Intervention / Treatment
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* Other: Interview
* Other: Media Intervention
* Other: Questionnaire Administration
* Other: Scale Device
* Behavioral: Telephone-Based Intervention
* Other: Text Message


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a history of HSCT of any type, at least 100 days post-transplant at initial consultation of the study, will be eligible for the study Patients must classify as obese, represented as body mass index (BMI) >= 85th percentile for age and gender Patients must also be able to read English since the app intervention is only available in English form No patients will be excluded for any specific underlying medical condition, but decisions will be made on a case by case basis if a patient's functioning is deemed to significantly interfere with intervention participation PARENT: His/her child meets all inclusion criteria >= 18 years of age Can speak English Exclusion Criteria: 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 Patients whose BMI does not fall under the obese category will be excluded

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive Care (app, scales, coaching, questionnaire)<br>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. | Other: Interview<br>* Participate in interviews<br>Other: Media Intervention<br>* Receive iPhone with W8Loss2Go app<br>Other: Questionnaire Administration<br>* Complete questionnaires<br>Other: Scale Device<br>* Receive body scale and food scale<br>* Other names: Scale;Behavioral: Telephone-Based Intervention<br>* Receive telephone calls<br>Other: Text Message<br>* Receive text message<br>* Other names: Text;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body mass index (BMI) status | The main outcomes measures will be height (meters), weight (kg), and BMI (kg/m^2). Height will be measured to assess consistency in height measurements. Weight will be measured to assess trends in weight over the time span of the intervention. BMI will be measured as a product of weight and height to obtain an appropriate metric that accounts for these measures, and is the standard measure to assess weight progression in weight intervention studies. | Baseline up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | Compliance with app intervention will be measured by daily interaction with the application and the coach. A point system has been designed in the application to measure compliance with the app intervention, measured by +/- weight measured daily, logging of problem foods, logging of snacking panel, and logging of meals. The coach interacts with the participants through text daily, and through phone calls weekly. | Up to 12 months | 
| Fasting lab test analysis: HbA1c | HbA1c: Glycated hemoglobin (A1C) test result reflects your average blood sugar level for the past two to three months. Specifically, the A1C test measures what percentage of your hemoglobin is coated with sugar. The healthy range is between 4% and 5.6% | At four months up to 12 months | 
| Fasting lab test analysis: Total cholesterol | Total cholesterol: This measures the overall amount of cholesterol in your blood. The healthy range is < 170 mg/dL | At four months up to 12 months | 
| Fasting lab test analysis: Low density lipoprotein | LDL: low density lipoprotein (LDL) is the bad cholesterol in your blood. The healthy range is <100 mg/dL | At four months up to 12 months | 
| Fasting lab test analysis: High density lipoprotein | HDL: high density lipoprotein (HDL) is the good cholesterol in your blood. The healthy range is > 45 mg/dL | At four months up to 12 months | 
| Fasting lab test analysis: triglycerides | TG: triglycerides (TG) are a type of lipid in your blood. The healthy range is < 150 mg/dL | At four months up to 12 months | 
| Fasting lab test analysis: aspartate/alanine aminotransferase | AST/ALT: aspartate/alanine aminotransferase (AST/ALT) are liver enzymes to measure liver health. The healthy range or AST is 10-34 IU/L and the healthy range for ALT is 8-37 IU/L. | At four months up to 12 months | 
| Fasting lab test analysis: glucose | Glucose: This measures the amount of sugar in your blood. We measure this after fasting for 8 hours. The healthy range is 70-99 mg/dL | At four months up to 12 months | 
| Yale Food Addiction Scale | visual analog scale (1: never to 5:always). Higher scores may suggest more addictive like eating | Up to 12 months | 
| Center for epidemiologic studies depression scale | 4 categorical options (never/rarely, sometimes, moderately, all of the time). A higher score suggests utility for screening for depression | Up to 12 months | 
| Perceived stress scale | Likert Scale (0: never to 4:very often). Higher scores suggests higher stress | Up to 12 months | 
| Satisfaction with program | Measured by Satisfaction Survey. This Likert Scale will be completed by the participant and their parent at the end of the study. This scale uses a Likert Scale where 1 = completely disagree to 7 = completely agree. Higher scores suggest greater satisfaction with the intervention. | Up to 12 months | 
| Demographic questionnaire | 10 questions with varying options to inquire about common demographic questions (gender, age, primary language, etc). Questions are descriptive in nature and no score is assigned. | Up to 12 months | 
| Food craving questionnaire | Likert scale (1: never to 5: always). A higher score suggests higher degrees of food cravings | Up to 12 months | 
| Binge eating disorder screen | 4 categorical options (never/rarely, sometimes, often, always). A higher score suggests utility for screening for binge eating disorder | Up to 12 months | 
| Physical activity questionnaire | participants identify number of times (0 to more than 7) that they conducted a particular physical activity in the past 7 days. This includes skipping, rowing, etc. | Up to 12 months | 
| S weight | Likert scale (1: strongly disagree to 5: strongly agree). Higher scores indicates more motivation for change in weight | Up to 12 months | 
| Height encounters questionnaire | six questions about the participants health care utilization in the past month. Questions are descriptive in nature and no score is assigned. | Up to 12 months |