ObesityNCT04997473
Behavioral Weight Loss Intervention Utilizing Mobile Health Technology in Hematopoietic Stem Cell Transplant Patients
A study testing W8L2G mobile health (mHealth) app in people with Obesity and Stem Cell Transplant, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Stem Cell Transplant
- What is being tested?
- W8L2G mobile health (mHealth) app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2021to 9 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UCLA Mattel Children's Hospital
Los Angeles, California, 90095
Belen Ramirez, 3102670425, belenramirez@mednet.ucla.edu
About this study
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.
- Conditions
- Obesity, Stem Cell Transplant
- Being tested
- W8L2G mobile health (mHealth) app
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
W8L2G mobile health (mHealth) appBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: W8L2G mobile health (mHealth) app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start15 Aug 2021
- Primary completion9 Jan 2027 (estimated)
- Study completion9 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Theodore Moore, University of California, Los Angeles
- Investigators
- Theodore B Moore, MD, Principal investigator, UCLA Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997473
- Sponsor's protocol ID
- UCLA BWL001
- Status last verified
- Jan 2026
- First submitted
- 23 Jul 2021
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Weight Loss Intervention Utilizing Mobile Health Technology in Hematopoietic Stem Cell Transplant Patients
- ClinicalTrials.gov ID
- NCT04997473
- Acronym / sponsor ID
- UCLA BWL001
- Conditions
- Obesity, Stem Cell Transplant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 9 Jan 2027 (estimated)
- Study completion
- 9 Jan 2027 (estimated)
- First posted
- 9 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| App Group | Experimental | Behavioral: W8L2G mobile health (mHealth) appParticipants will be receiving an addiction model based mobile health (mHealth) weight loss intervention with coaching for a total of 4 months duration |
Who may qualify
- Ages
- 13 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| W8L2G 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 | Behavioural | App Group |
Primary outcome
BMI
Time frame: 4 months
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.
1 secondary outcome
Behavioral changes, metabolic parameters, feasibility of app
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Theodore B Moore, MD principal investigator
UCLA Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing W8L2G mobile health (mHealth) app in people with Obesity and Stem Cell Transplant, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Belen Ramirez (3102670425, belenramirez@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.