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

Recruiting

• Conditions: Obesity; Malignant Neoplasm
• Interventions: Other: Interview; Other: Media Intervention; Other: Questionnaire Administration; Other: Scale Device; Behavioral: Telephone-Based Intervention; Other: Text Message

• Registration Number: NCT04453072
• Lead Sponsor: Jonsson Comprehensive Cancer Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-06-10
• Study First Submitted QC: 2020-06-29
• Study Start: 2020-07-01
• Study First Posted: 2020-07-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-13
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive Care (app, scales, coaching, questionnaire)	Scale Device	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.
Supportive Care (app, scales, coaching, questionnaire)	Media Intervention	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.
Supportive Care (app, scales, coaching, questionnaire)	Telephone-Based Intervention	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.
Supportive Care (app, scales, coaching, questionnaire)	Interview	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.
Supportive Care (app, scales, coaching, questionnaire)	Text Message	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.
Supportive Care (app, scales, coaching, questionnaire)	Questionnaire Administration	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.

Primary Outcome Measures

Name	Time	Method
Change in body mass index (BMI) status	Baseline up to 12 months	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.

Secondary Outcome Measures

Name	Time	Method
Fasting lab test analysis: HbA1c	At four months up to 12 months	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%
Fasting lab test analysis: triglycerides	At four months up to 12 months	TG: triglycerides (TG) are a type of lipid in your blood. The healthy range is \< 150 mg/dL
Adherence	Up to 12 months	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.
Fasting lab test analysis: aspartate/alanine aminotransferase	At four months up to 12 months	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.
Yale Food Addiction Scale	Up to 12 months	visual analog scale (1: never to 5:always). Higher scores may suggest more addictive like eating
Center for epidemiologic studies depression scale	Up to 12 months	4 categorical options (never/rarely, sometimes, moderately, all of the time). A higher score suggests utility for screening for depression
Binge eating disorder screen	Up to 12 months	4 categorical options (never/rarely, sometimes, often, always). A higher score suggests utility for screening for binge eating disorder
Physical activity questionnaire	Up to 12 months	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.
Perceived stress scale	Up to 12 months	Likert Scale (0: never to 4:very often). Higher scores suggests higher stress
Fasting lab test analysis: glucose	At four months up to 12 months	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
Food craving questionnaire	Up to 12 months	Likert scale (1: never to 5: always). A higher score suggests higher degrees of food cravings
Fasting lab test analysis: Total cholesterol	At four months up to 12 months	Total cholesterol: This measures the overall amount of cholesterol in your blood. The healthy range is \< 170 mg/dL
Fasting lab test analysis: Low density lipoprotein	At four months up to 12 months	LDL: low density lipoprotein (LDL) is the bad cholesterol in your blood. The healthy range is \<100 mg/dL
Demographic questionnaire	Up to 12 months	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.
S weight	Up to 12 months	Likert scale (1: strongly disagree to 5: strongly agree). Higher scores indicates more motivation for change in weight
Fasting lab test analysis: High density lipoprotein	At four months up to 12 months	HDL: high density lipoprotein (HDL) is the good cholesterol in your blood. The healthy range is \> 45 mg/dL
Satisfaction with program	Up to 12 months	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.
Height encounters questionnaire	Up to 12 months	six questions about the participants health care utilization in the past month. Questions are descriptive in nature and no score is assigned.

Trial Locations

Locations (1)

UCLA / Jonsson Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States