Clinical Trials Directory

Trials / Recruiting

RecruitingNCT04453072

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

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
20 (estimated)
Sponsor
Jonsson Comprehensive Cancer Center · Academic / Other
Sex
All
Age
13 Years – 30 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
OTHERInterviewParticipate in interviews
OTHERMedia InterventionReceive iPhone with W8Loss2Go app
OTHERQuestionnaire AdministrationComplete questionnaires
OTHERScale DeviceReceive body scale and food scale
BEHAVIORALTelephone-Based InterventionReceive telephone calls
OTHERText MessageReceive text message

Timeline

Start date
2020-07-01
Primary completion
2025-12-31
Completion
2026-12-31
First posted
2020-07-01
Last updated
2025-05-13

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04453072. Inclusion in this directory is not an endorsement.