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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04453072
• Other study ID #: 19-001992
• Secondary ID: NCI-2020-02687
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms
• Obesity
• Weight Loss

Intervention

Other:
• Interview
Participate in interviews
• Media Intervention
Receive iPhone with W8Loss2Go app
• Questionnaire Administration
Complete questionnaires
• Scale Device
Receive body scale and food scale

Behavioral:
• Telephone-Based Intervention
Receive telephone calls

Other:
• Text Message
Receive text message

Locations

Country	Name	City	State
United States	UCLA / Jonsson Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	eHealth International, INC.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Yale Food Addiction Scale	visual analog scale (1: never to 5:always). Higher scores may suggest more addictive like eating	Up to 12 months
Secondary	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
Secondary	Perceived stress scale	Likert Scale (0: never to 4:very often). Higher scores suggests higher stress	Up to 12 months
Secondary	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
Secondary	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
Secondary	Food craving questionnaire	Likert scale (1: never to 5: always). A higher score suggests higher degrees of food cravings	Up to 12 months
Secondary	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
Secondary	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
Secondary	S weight	Likert scale (1: strongly disagree to 5: strongly agree). Higher scores indicates more motivation for change in weight	Up to 12 months
Secondary	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