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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Interview, Media Intervention, Questionnaire Administration, Scale Device.
- Who it may be relevant to
- Registry conditions: Obesity, Malignant Neoplasm. Basic parameters: 13 years — 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Behavioral Weight Loss Intervention Utilizing Mobile Health Technology in Hematopoietic Stem Cell Transplant Patients (BWL001)
Overview
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:
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.
Interventions
- Other Interview
Participate in interviews - Other Media Intervention
Receive iPhone with W8Loss2Go app - Other Questionnaire Administration
Complete questionnaires - Other Scale Device
Receive body scale and food scale - Behavioral Telephone-Based Intervention
Receive telephone calls - Other Text Message
Receive text message
Primary outcome measures
- Change in body mass index (BMI) status [Time frame: Baseline up to 12 months]
Secondary outcome measures (12)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- UCLA / Jonsson Comprehensive Cancer Center — Los Angeles
Identifiers
NCT: NCT04453072 · 19-001992 · NCI-2020-02687