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

NCT ID: NCT04453072

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2026-12-31

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.

Conditions

Obesity; Malignant Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Supportive Care (app, scales, coaching, questionnaire)

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.

Group Type: EXPERIMENTAL

Interview

Intervention Type: OTHER

Participate in interviews

Media Intervention

Intervention Type: OTHER

Receive iPhone with W8Loss2Go app

Questionnaire Administration

Intervention Type: OTHER

Complete questionnaires

Scale Device

Intervention Type: OTHER

Receive body scale and food scale

Telephone-Based Intervention

Intervention Type: BEHAVIORAL

Receive telephone calls

Text Message

Intervention Type: OTHER

Receive text message

Interventions

Interview

Participate in interviews

Intervention Type: OTHER

Media Intervention

Receive iPhone with W8Loss2Go app

Intervention Type: OTHER

Questionnaire Administration

Complete questionnaires

Intervention Type: OTHER

Scale Device

Receive body scale and food scale

Intervention Type: OTHER

Telephone-Based Intervention

Receive telephone calls

Intervention Type: BEHAVIORAL

Text Message

Receive text message

Intervention Type: OTHER

Other Intervention Names

Scale; Short Message Service (SMS) Text; SMS Text Message; Text

Eligibility Criteria

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:
• >= 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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

eHealth International, INC.

UNKNOWN

Sponsor Role: collaborator

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Theodore B Moore

Role: PRINCIPAL_INVESTIGATOR

UCLA / Jonsson Comprehensive Cancer Center

Locations

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Theodore B. Moore

Role: primary

tbmoore@mednet.ucla.edu

310-794-8929

Other Identifiers

NCI-2020-02687

Identifier Type: REGISTRY

Identifier Source: secondary_id

19-001992

Identifier Type: -

Identifier Source: org_study_id