ObesityNCT04453072
A Study to See if an iPhone Weight Management App Can Help Promote Weight Loss in Adolescents and Young Adults After a Stem Cell Transplant
A study testing Interview, Media Intervention and Questionnaire Administration in people with Obesity and Malignant Neoplasm, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
This early phase I trial studies how well a behavioral weight loss intervention consisting of a smartphone application and coaching works for the promotion of weight loss in adolescents and young adults after a stem cell transplant. Read more about this study
- Who is it for?
- Ages 13 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Malignant Neoplasm
- What is being tested?
- Interview, Media Intervention and Questionnaire Administration
- 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
- 1 Jul 2020to 31 Dec 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 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
- 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
- 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
- PARENT:
- His/her child meets all inclusion criteria
- >= 18 years of age
- Can speak English
Who cannot join
- 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
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 / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
Theodore B. Moore, 310-794-8929, tbmoore@mednet.ucla.edu
Theodore B. Moore
About this study
Official title: Behavioral Weight Loss Intervention Utilizing Mobile Health Technology in Hematopoietic Stem Cell Transplant Patients (BWL001)
This early phase I trial studies how well a behavioral weight loss intervention consisting of a smartphone application and coaching works for the promotion of weight loss in adolescents and young adults after a stem cell transplant. This study may help researchers learn more about how adolescents and young adults can lose weight and develop healthy eating habits.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the effectiveness of an addiction-based weight loss intervention, embodied as a smartphone application (app) with telephone coaching, on weight outcomes of overweight and obese post hematopoietic stem cell transplantation (HSCT) adolescents and young adults.
SECONDARY OBJECTIVES:
- To evaluate the changes in metabolic parameters and physical activity levels, in addition to modifications in addictive eating behaviors, motivation, and self-regulatory behaviors.
II. To evaluate the feasibility, adherence, and satisfaction of this intervention.
OUTLINE:
Patients receive an iPhone with W8Loss2Go app, a body scale and a digital food scale to weigh themselves and food daily. Patients interact with coaches via text messages for 4 days weekly and receive weekly 15 minute phone calls for appointment reminders, emotional support, progress discussion, and follow up on items discussed in a prior visit or phone call. Patients also have telemedicine interviews with the coach lasting 60 minutes at 2 and 4 months to elicit both positive and negative impacts on weight management and to identify barriers such as emotional eating, displacement behaviors, poor coping skills to life stressors, and social challenges. Patients who opt to extend the intervention until month 12 attend an additional telemedicine meeting with the coach. Patients also complete questionnaires over approximately 1.5 hours.
- Conditions
- Obesity, Malignant Neoplasm
- Being tested
- Interview, Media Intervention, Questionnaire Administration, Scale Device, Telephone-Based Intervention
- Medical subject headings
- Obesity, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Participate in interviews
Media InterventionOther
Receive iPhone with W8Loss2Go app
Questionnaire AdministrationOther
Complete questionnaires
Scale DeviceOther
Also called Scale
Receive body scale and food scale
Telephone-Based InterventionBehavioural
Receive telephone calls
Text MessageOther
Also called Short Message Service (SMS) Text, SMS Text Message, Text
Receive text message
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care (app, scales, coaching, questionnaire) | Experimental | Patients receive an iPhone with W8Loss2Go app, a body scale and a digital food scale to weigh themselves and food daily. Patients interact with coaches via text messages for 4 days weekly and receive weekly 15 minute phone calls for appointment reminders, emotional support, progress discussion, and follow up on items discussed in a prior visit or phone call. Patients also have telemedicine interviews with the coach lasting 60 minutes at 2 and 4 months to elicit both positive and negative impacts on weight management and to identify barriers such as emotional eating, displacement behaviors, poor coping skills to life stressors, and social challenges. Patients who opt to extend the intervention until month 12 attend an additional telemedicine meeting with the coach. Patients also complete questionnaires over approximately 1.5 hours. Receives: Other: Interview; Other: Media Intervention; Other: Questionnaire Administration; Other: Scale Device; Behavioral: Telephone-Based Intervention; Other: Text Message |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body mass index (BMI) status
The main outcomes measures will be height (meters), weight (kg), and BMI (kg/m^2). Height will be measured to assess consistency in height measurements. Weight will be measured to assess trends in weight over the time span of the intervention. BMI will be measured as a product of weight and height to obtain an appropriate metric that accounts for these measures, and is the standard measure to assess weight progression in weight intervention studies.
Measured: Baseline up to 12 months
Secondary outcomes (18)
Adherence
Compliance with app intervention will be measured by daily interaction with the application and the coach. A point system has been designed in the application to measure compliance with the app intervention, measured by +/- weight measured daily, logging of problem foods, logging of snacking panel, and logging of meals. The coach interacts with the participants through text daily, and through phone calls weekly.
Measured: Up to 12 months
Fasting lab test analysis: HbA1c
HbA1c: Glycated hemoglobin (A1C) test result reflects your average blood sugar level for the past two to three months. Specifically, the A1C test measures what percentage of your hemoglobin is coated with sugar. The healthy range is between 4% and 5.6%
Measured: At four months up to 12 months
Fasting lab test analysis: Total cholesterol
Total cholesterol: This measures the overall amount of cholesterol in your blood. The healthy range is < 170 mg/dL
Measured: At four months up to 12 months
Fasting lab test analysis: Low density lipoprotein
LDL: low density lipoprotein (LDL) is the bad cholesterol in your blood. The healthy range is <100 mg/dL
Measured: At four months up to 12 months
Fasting lab test analysis: High density lipoprotein
HDL: high density lipoprotein (HDL) is the good cholesterol in your blood. The healthy range is > 45 mg/dL
Measured: At four months up to 12 months
Fasting lab test analysis: triglycerides
TG: triglycerides (TG) are a type of lipid in your blood. The healthy range is < 150 mg/dL
Measured: At four months up to 12 months
Fasting lab test analysis: aspartate/alanine aminotransferase
AST/ALT: aspartate/alanine aminotransferase (AST/ALT) are liver enzymes to measure liver health. The healthy range or AST is 10-34 IU/L and the healthy range for ALT is 8-37 IU/L.
Measured: At four months up to 12 months
Fasting lab test analysis: glucose
Glucose: This measures the amount of sugar in your blood. We measure this after fasting for 8 hours. The healthy range is 70-99 mg/dL
Measured: At four months up to 12 months
Yale Food Addiction Scale
visual analog scale (1: never to 5:always). Higher scores may suggest more addictive like eating
Measured: Up to 12 months
Center for epidemiologic studies depression scale
4 categorical options (never/rarely, sometimes, moderately, all of the time). A higher score suggests utility for screening for depression
Measured: Up to 12 months
Perceived stress scale
Likert Scale (0: never to 4:very often). Higher scores suggests higher stress
Measured: Up to 12 months
Satisfaction with program
Measured by "Satisfaction Survey". This Likert Scale will be completed by the participant and their parent at the end of the study. This scale uses a Likert Scale where 1 = completely disagree to 7 = completely agree. Higher scores suggest greater satisfaction with the intervention.
Measured: Up to 12 months
Demographic questionnaire
10 questions with varying options to inquire about common demographic questions (gender, age, primary language, etc). Questions are descriptive in nature and no score is assigned.
Measured: Up to 12 months
Food craving questionnaire
Likert scale (1: never to 5: always). A higher score suggests higher degrees of food cravings
Measured: Up to 12 months
Binge eating disorder screen
4 categorical options (never/rarely, sometimes, often, always). A higher score suggests utility for screening for binge eating disorder
Measured: Up to 12 months
Physical activity questionnaire
participants identify number of times (0 to more than 7) that they conducted a particular physical activity in the past 7 days. This includes skipping, rowing, etc.
Measured: Up to 12 months
S weight
Likert scale (1: strongly disagree to 5: strongly agree). Higher scores indicates more motivation for change in weight
Measured: Up to 12 months
Height encounters questionnaire
six questions about the participants health care utilization in the past month. Questions are descriptive in nature and no score is assigned.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start1 Jul 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 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.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- eHealth International, INC.
- Responsible party
- Sponsor
- Investigators
- Theodore B Moore, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04453072
- Sponsor's protocol ID
- 19-001992
- Other IDs
- NCI-2020-02687
- Status last verified
- May 2026
- First submitted
- 10 Jun 2020
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 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 (BWL001)
- ClinicalTrials.gov ID
- NCT04453072
- Acronym / sponsor ID
- 19-001992
- Conditions
- Obesity, Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- eHealth International, INC.
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 Jul 2020 (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.
This early phase I trial studies how well a behavioral weight loss intervention consisting of a smartphone application and coaching works for the promotion of weight loss in adolescents and young adults after a stem cell transplant. This study may help researchers learn more about how adolescents and young adults can lose weight and develop healthy eating habits.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the effectiveness of an addiction-based weight loss intervention, embodied as a smartphone application (app) with telephone coaching, on weight outcomes of overweight and obese post hematopoietic stem cell transplantation (HSCT) adolescents and young adults.
SECONDARY OBJECTIVES:
- To evaluate the changes in metabolic parameters and physical activity levels, in addition to modifications in addictive eating behaviors, motivation, and self-regulatory behaviors.
II. To evaluate the feasibility, adherence, and satisfaction of this intervention.
OUTLINE:
Patients receive an iPhone with W8Loss2Go app, a body scale and a digital food scale to weigh themselves and food daily. Patients interact with coaches via text messages for 4 days weekly and receive weekly 15 minute phone calls for appointment reminders, emotional support, progress discussion, and follow up on items discussed in a prior visit or phone call. Patients also have telemedicine interviews with the coach lasting 60 minutes at 2 and 4 months to elicit both positive and negative impacts on weight management and to identify barriers such as emotional eating, displacement behaviors, poor coping skills to life stressors, and social challenges. Patients who opt to extend the intervention until month 12 attend an additional telemedicine meeting with the coach. Patients also complete questionnaires over approximately 1.5 hours.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (app, scales, coaching, questionnaire) | Experimental | Other: Interview, Other: Media Intervention, Other: Questionnaire Administration, Other: Scale Device, Behavioral: Telephone-Based Intervention, Other: Text MessagePatients receive an iPhone with W8Loss2Go app, a body scale and a digital food scale to weigh themselves and food daily. Patients interact with coaches via text messages for 4 days weekly and receive weekly 15 minute phone calls for appointment reminders, emotional support, progress discussion, and follow up on items discussed in a prior visit or phone call. Patients also have telemedicine interviews with the coach lasting 60 minutes at 2 and 4 months to elicit both positive and negative impacts on weight management and to identify barriers such as emotional eating, displacement behaviors, poor coping skills to life stressors, and social challenges. Patients who opt to extend the intervention until month 12 attend an additional telemedicine meeting with the coach. Patients also complete questionnaires over approximately 1.5 hours. |
Who may qualify
- Ages
- 13 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Patients 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
- 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
- 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
- PARENT:
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| InterviewParticipate in interviews | Other | Supportive Care (app, scales, coaching, questionnaire) |
| Media InterventionReceive iPhone with W8Loss2Go app | Other | Supportive Care (app, scales, coaching, questionnaire) |
| Questionnaire AdministrationComplete questionnaires | Other | Supportive Care (app, scales, coaching, questionnaire) |
| Scale DeviceAlso: ScaleReceive body scale and food scale | Other | Supportive Care (app, scales, coaching, questionnaire) |
| Telephone-Based InterventionReceive telephone calls | Behavioural | Supportive Care (app, scales, coaching, questionnaire) |
| Text MessageAlso: Short Message Service (SMS) Text, SMS Text Message, TextReceive text message | Other | Supportive Care (app, scales, coaching, questionnaire) |
Primary outcome
Change in body mass index (BMI) status
Time frame: Baseline up to 12 months
The main outcomes measures will be height (meters), weight (kg), and BMI (kg/m^2). Height will be measured to assess consistency in height measurements. Weight will be measured to assess trends in weight over the time span of the intervention. BMI will be measured as a product of weight and height to obtain an appropriate metric that accounts for these measures, and is the standard measure to assess weight progression in weight intervention studies.
18 secondary outcomes
Adherence
Time frame: Up to 12 months
Fasting lab test analysis: HbA1c
Time frame: At four months up to 12 months
Fasting lab test analysis: Total cholesterol
Time frame: At four months up to 12 months
Fasting lab test analysis: Low density lipoprotein
Time frame: At four months up to 12 months
Fasting lab test analysis: High density lipoprotein
Time frame: At four months up to 12 months
Fasting lab test analysis: triglycerides
Time frame: At four months up to 12 months
Fasting lab test analysis: aspartate/alanine aminotransferase
Time frame: At four months up to 12 months
Fasting lab test analysis: glucose
Time frame: At four months up to 12 months
Yale Food Addiction Scale
Time frame: Up to 12 months
Center for epidemiologic studies depression scale
Time frame: Up to 12 months
Perceived stress scale
Time frame: Up to 12 months
Satisfaction with program
Time frame: Up to 12 months
Demographic questionnaire
Time frame: Up to 12 months
Food craving questionnaire
Time frame: Up to 12 months
Binge eating disorder screen
Time frame: Up to 12 months
Physical activity questionnaire
Time frame: Up to 12 months
S weight
Time frame: Up to 12 months
Height encounters questionnaire
Time frame: Up to 12 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 11 May 2026.
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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.
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, United States
Theodore B Moore principal investigator
UCLA / Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interview, Media Intervention and Questionnaire Administration in people with Obesity and Malignant Neoplasm, run by Jonsson Comprehensive Cancer Center 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 8 inclusion and 2 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 11 May 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body mass index (BMI) status (time frame: Baseline up to 12 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 11 May 2026.