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

Jonsson Comprehensive Cancer Center20 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Interventions

InterviewOTHER

Participate in interviews

Media InterventionOTHER

Receive iPhone with W8Loss2Go app

Questionnaire AdministrationOTHER

Complete questionnaires

Scale DeviceOTHER

Receive body scale and food scale

Telephone-Based InterventionBEHAVIORAL

Receive telephone calls

Text MessageOTHER

Receive text message

Eligibility

Sex: ALLMin age: 13 YearsMax age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Baseline up to 12 months

Secondary Outcomes

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.

Time frame: 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%