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NCT04453072 | RECRUITING | Obesity

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
Sponsor:

Jonsson Comprehensive Cancer Center

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.

Condition or disease

Obesity

Malignant Neoplasm

Intervention/treatment

Interview

Media Intervention

Questionnaire Administration

Scale Device

Telephone-Based Intervention

Text Message

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 20 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Behavioral Weight Loss Intervention Utilizing Mobile Health Technology in Hematopoietic Stem Cell Transplant Patients (BWL001)
Actual Study Start Date : 2020-07-01
Estimated Primary Completion Date : 2025-12-31
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 13 Years to 30 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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:
  • * 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
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

Location Details

NCT04453072

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How to Participate

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Locations

RECRUITING

United States, California

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States, 90095