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

NCT04997473 | Recruiting

• 1 other identifier: UCLA BWL001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Pilot study enrolling obese post HSCT (hematopoietic stem cell transplantation) patients at the hematology/oncology clinic at the Mattel Children's Hospital, University of California, Los Angeles. Parameters include percent over the 95th percentile (%BMIp95), zBMI, fasting metabolic metrics, addictive eating habits, and motivation for change.

Conditions

Obesity; Stem Cell Transplant

Outcome Measures

Primary Outcomes (1)

• BMI

  To evaluate the effectiveness of an addiction-based weight loss intervention, embodied as a smartphone app with telephone coaching, on weight (weight and height will be combined to report BMI in kg/m\^2) outcomes of overweight and obese post HSCT adolescents and young adults.

  4 months

Secondary Outcomes (1)

• Behavioral changes, metabolic parameters, feasibility of app

  4 months

Study Arms (1)

App Group

EXPERIMENTAL

Participants will be receiving an addiction model based mobile health (mHealth) weight loss intervention with coaching for a total of 4 months duration

Behavioral: W8L2G mobile health (mHealth) app

Interventions

W8L2G mobile health (mHealth) app BEHAVIORAL

Weight loss phone app based on addiction principles. This intervention has been validated in two prior studies. Participants will also interact with coaches throughout the intervention

App Group

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 ≥ 13 and ≤ 30 years old 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.
• Both male and female patients will be eligible.
• 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.

You may not qualify if:

• Patients who are ≤ 13 or ≥ 30 years old are not eligible for the study.
• 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.
• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Mattel Children's Hospital

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Telemedicine; Amyloid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration; Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Theodore B Moore, MD

  UCLA Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Belen Ramirez

CONTACT

3102670425; belenramirez@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Evaluate the effectiveness of an addiction model based mobile health (mHealth) weight loss intervention with coaching in obese pediatric patients after hematopoietic stem cell transplant

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: August 9, 2021
• Study Start: August 15, 2021
• Primary Completion (Estimated): January 9, 2027
• Study Completion (Estimated): January 9, 2027
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)