About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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 design
Single group
Treatments tested in this trial
Interview
Other interventionParticipate in interviews
Media Intervention
Other interventionReceive iPhone with W8Loss2Go app
Questionnaire Administration
Other interventionComplete questionnaires
Scale Device
Other interventionReceive body scale and food scale
Telephone-Based Intervention
BehavioralReceive telephone calls
Text Message
Other interventionReceive text message
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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%
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
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
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jonsson Comprehensive Cancer Center
Lead sponsor
eHealth International, INC.
Collaborator