Behavioral Weight Loss Intervention Utilizing Mobile Health Technology in Hematopoietic Stem Cell Transplant Patients
Primary Purpose
Obesity, Stem Cell Transplant
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
W8L2G mobile health (mHealth) app
Sponsored by
About this trial
This is an interventional other trial for Obesity
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- UCLA Mattel Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
App Group
Arm Description
Participants will be receiving an addiction model based mobile health (mHealth) weight loss intervention with coaching for a total of 4 months duration
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Behavioral changes, metabolic parameters, feasibility of app
To evaluate the changes in metabolic parameters and physical activity levels, in addition to modifications in addictive eating behaviors, motivation, and self-regulatory behaviors. To evaluate the feasibility, adherence, and satisfaction of this intervention.
Full Information
NCT ID
NCT04997473
First Posted
July 23, 2021
Last Updated
October 24, 2022
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT04997473
Brief Title
Behavioral Weight Loss Intervention Utilizing Mobile Health Technology in Hematopoietic Stem Cell Transplant Patients
Official Title
Behavioral Weight Loss Intervention Utilizing Mobile Health Technology in Hematopoietic Stem Cell Transplant Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
This is a pilot study enrolling obese patients, age 13-30, in an addiction model based smartphone mobile health (mHealth) weight loss intervention with coaching at a minimum of 100 days after hematopoietic stem cell transplantation. Patients will be screened and enrolled by the study coordinator, who will collect/submit biospecimens in addition to patient demographic characteristics and clinical outcomes. At the initial visit and enrollment, equipment will be disbursed to patients along with a schedule that outlines the 4-month intervention plan. After the initial visit, participants will participate in two additional in-clinic visits at 2 months and at the conclusion of the study at 4 months. Participants will also be involved in weekly phone calls and daily weekday texts to discuss their status for the 4 month duration.
This study will then correlate the results in change of BMI with patient characteristics, adherence to intervention, changes in metabolic parameters, physical activity levels, and addictive eating behaviors. Investigators are aiming to recruit a total of 20 adolescents/young adults total. No pilot group is necessary since the feasibility of this intervention has been validated in prior published studies.
The proposed model of delivery makes it possible to: 1) intervene with the participant and provide autonomy, 2) deliver the material over an extended period of time in a more convenient platform for the participant and families, 3) reduce many access barriers common in conventional outpatient obesity interventions, such as transportation or missed days of school and work, and 4) help youth develop skills to overcome their addictive eating behaviors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Stem Cell Transplant
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
App Group
Arm Type
Experimental
Arm Description
Participants will be receiving an addiction model based mobile health (mHealth) weight loss intervention with coaching for a total of 4 months duration
Intervention Type
Behavioral
Intervention Name(s)
W8L2G mobile health (mHealth) app
Intervention Description
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
Primary Outcome Measure Information:
Title
BMI
Description
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.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Behavioral changes, metabolic parameters, feasibility of app
Description
To evaluate the changes in metabolic parameters and physical activity levels, in addition to modifications in addictive eating behaviors, motivation, and self-regulatory behaviors. To evaluate the feasibility, adherence, and satisfaction of this intervention.
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andres Vargas
Phone
3108256742
Email
andresvargas@mednet.ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theodore B Moore, MD
Organizational Affiliation
UCLA Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Mattel Children's Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andres Vargas
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Behavioral Weight Loss Intervention Utilizing Mobile Health Technology in Hematopoietic Stem Cell Transplant Patients
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