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

NCT04453072 | Recruiting

• 2 other identifiers: 19-001992NCI-2020-02687
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• Adherence

  Up to 12 months

• Fasting lab test analysis: HbA1c

  At four months up to 12 months

• Fasting lab test analysis: Total cholesterol

  At four months up to 12 months

• Fasting lab test analysis: Low density lipoprotein

  At four months up to 12 months

• Fasting lab test analysis: High density lipoprotein

  At four months up to 12 months

Study Arms (1)

Supportive Care (app, scales, coaching, questionnaire)

EXPERIMENTAL

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; Other: Media Intervention; Other: Questionnaire Administration; Other: Scale Device; Behavioral: Telephone-Based Intervention; Other: Text Message

Interventions

Interview OTHER

Participate in interviews

Supportive Care (app, scales, coaching, questionnaire)

Media Intervention OTHER

Receive iPhone with W8Loss2Go app

Supportive Care (app, scales, coaching, questionnaire)

Questionnaire Administration OTHER

Complete questionnaires

Supportive Care (app, scales, coaching, questionnaire)

Scale Device OTHER

Receive body scale and food scale

Also known as: Scale

Supportive Care (app, scales, coaching, questionnaire)

Telephone-Based Intervention BEHAVIORAL

Receive telephone calls

Supportive Care (app, scales, coaching, questionnaire)

Text Message OTHER

Receive text message

Also known as: Short Message Service (SMS) Text, SMS Text Message, Text

Supportive Care (app, scales, coaching, questionnaire)

Eligibility Criteria

• Age: 13 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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:
• \>= 18 years of age
• Can speak English

You may not qualify if:

• 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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• eHealth International, INC.: collaborator

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Neoplasms

Interventions

Interviews as Topic; Weights and Measures; Spermine Synthase; Communication Devices for People with Disabilities

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Alkyl and Aryl Transferases; Transferases; Enzymes; Enzymes and Coenzymes; Self-Help Devices; Equipment and Supplies

Study Officials

• Theodore B Moore

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: July 1, 2020
• Study Start: July 1, 2020
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-04

Locations

US (1)