Clinical Trials Directory

Trials / Recruiting

RecruitingNCT04997473

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
20 (estimated)
Sponsor
University of California, Los Angeles · Academic / Other
Sex
All
Age
13 Years – 30 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALW8L2G mobile health (mHealth) appWeight 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

Timeline

Start date
2021-08-15
Primary completion
2027-01-09
Completion
2027-01-09
First posted
2021-08-09
Last updated
2026-01-28

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04997473. Inclusion in this directory is not an endorsement.