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RecruitingNCT04997473Updated Jan 28, 2026

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

An interventional study of W8L2G mobile health (mHealth) app in Obesity and Stem Cell Transplant, sponsored by University of California, Los Angeles. Recruiting at 1 site in United States. Open to participants aged 13 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-28.

Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Aug 2021; still recruiting 5 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
13 Years to 30 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Obesity
  • Stem Cell Transplant

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03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,695 are open to participants now.

This study's planned enrollment of 20 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    App Group

    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

  • BehavioralW8L2G mobile health (mHealth) app

    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

06

What researchers measure

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.

    Time frame: 4 months

Secondary outcomes

  1. 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.

    Time frame: 4 months

07

Study locations

1 of 1 sites recruiting
  • UCLA Mattel Children's Hospital
    Los Angeles, California 90095, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04997473
Lead sponsor
University of California, Los Angeles
Responsible party
Theodore Moore (Principal Investigator, University of California, Los Angeles) — Principal investigator
First posted
Aug 9, 2021
Start date
Aug 15, 2021
Primary completion
Jan 9, 2027 (estimated)
Completion
Jan 9, 2027 (estimated)
Last update
Jan 28, 2026

Study contacts

Belen Ramirez
Contact
belenramirez@mednet.ucla.edu
3102670425
Theodore B Moore, MD
principal investigator · UCLA Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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