- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04453072
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
Behavioral Weight Loss Intervention Utilizing Mobile Health Technology in Hematopoietic Stem Cell Transplant Patients (BWL001)
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVE:
I. 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:
I. 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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- Recruiting
- UCLA / Jonsson Comprehensive Cancer Center
-
Contact:
- Theodore B. Moore
- Phone Number: 310-794-8929
- Email: tbmoore@mednet.ucla.edu
-
Principal Investigator:
- Theodore B. Moore
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Supportive Care (app, scales, coaching, questionnaire)
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.
|
Complete questionnaires
Participate in interviews
Receive iPhone with W8Loss2Go app
Receive body scale and food scale
Other Names:
Receive telephone calls
Receive text message
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence
Time Frame: Up to 12 months
|
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.
|
Up to 12 months
|
Fasting lab test analysis: HbA1c
Time Frame: At four months up to 12 months
|
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%
|
At four months up to 12 months
|
Fasting lab test analysis: Total cholesterol
Time Frame: At four months up to 12 months
|
Total cholesterol: This measures the overall amount of cholesterol in your blood.
The healthy range is < 170 mg/dL
|
At four months up to 12 months
|
Fasting lab test analysis: Low density lipoprotein
Time Frame: At four months up to 12 months
|
LDL: low density lipoprotein (LDL) is the bad cholesterol in your blood.
The healthy range is <100 mg/dL
|
At four months up to 12 months
|
Fasting lab test analysis: High density lipoprotein
Time Frame: At four months up to 12 months
|
HDL: high density lipoprotein (HDL) is the good cholesterol in your blood.
The healthy range is > 45 mg/dL
|
At four months up to 12 months
|
Fasting lab test analysis: triglycerides
Time Frame: At four months up to 12 months
|
TG: triglycerides (TG) are a type of lipid in your blood.
The healthy range is < 150 mg/dL
|
At four months up to 12 months
|
Fasting lab test analysis: aspartate/alanine aminotransferase
Time Frame: At four months up to 12 months
|
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.
|
At four months up to 12 months
|
Fasting lab test analysis: glucose
Time Frame: At four months up to 12 months
|
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
|
At four months up to 12 months
|
Yale Food Addiction Scale
Time Frame: Up to 12 months
|
visual analog scale (1: never to 5:always).
Higher scores may suggest more addictive like eating
|
Up to 12 months
|
Center for epidemiologic studies depression scale
Time Frame: Up to 12 months
|
4 categorical options (never/rarely, sometimes, moderately, all of the time).
A higher score suggests utility for screening for depression
|
Up to 12 months
|
Perceived stress scale
Time Frame: Up to 12 months
|
Likert Scale (0: never to 4:very often).
Higher scores suggests higher stress
|
Up to 12 months
|
Satisfaction with program
Time Frame: Up to 12 months
|
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.
|
Up to 12 months
|
Demographic questionnaire
Time Frame: Up to 12 months
|
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.
|
Up to 12 months
|
Food craving questionnaire
Time Frame: Up to 12 months
|
Likert scale (1: never to 5: always).
A higher score suggests higher degrees of food cravings
|
Up to 12 months
|
Binge eating disorder screen
Time Frame: Up to 12 months
|
4 categorical options (never/rarely, sometimes, often, always).
A higher score suggests utility for screening for binge eating disorder
|
Up to 12 months
|
Physical activity questionnaire
Time Frame: Up to 12 months
|
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.
|
Up to 12 months
|
S weight
Time Frame: Up to 12 months
|
Likert scale (1: strongly disagree to 5: strongly agree).
Higher scores indicates more motivation for change in weight
|
Up to 12 months
|
Height encounters questionnaire
Time Frame: Up to 12 months
|
six questions about the participants health care utilization in the past month.
Questions are descriptive in nature and no score is assigned.
|
Up to 12 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Theodore B Moore, UCLA / Jonsson Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-001992
- NCI-2020-02687 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
-
Consorcio Centro de Investigación Biomédica en...Maimónides Biomedical Research Institute of Córdoba; Instituto de Salud Carlos... and other collaboratorsActive, not recruiting
-
University of HoustonBaylor College of MedicineCompleted
Clinical Trials on Questionnaire Administration
-
Fondazione Don Carlo Gnocchi OnlusUnknown
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI)TerminatedHealth Status UnknownUnited States
-
Istanbul Aydın UniversityCompleted
-
Centre Oscar LambretCentre Hospitalier Universitaire de BesanconTerminated
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingLi-Fraumeni SyndromeUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingMetastatic Malignant Neoplasm | Caregiver | Advanced Malignant Neoplasm | Locally Advanced Malignant NeoplasmUnited States
-
Istituto Auxologico ItalianoCompletedObesity | Eating DisordersItaly
-
Vanderbilt-Ingram Cancer CenterTerminatedMalignant NeoplasmUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedMalignant NeoplasmUnited States
-
Federico II UniversityUnknownSleep Disorder | Renal Transplant | Hypertension; NephropathyItaly