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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04453072
Recruitment Status : Recruiting
First Posted : July 1, 2020
Last Update Posted : July 7, 2022
Sponsor:
Collaborator:
eHealth International, INC.
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE June 10, 2020
First Posted Date  ICMJE July 1, 2020
Last Update Posted Date July 7, 2022
Actual Study Start Date  ICMJE July 1, 2020
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2020)
  • 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.
  • 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%
  • 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
  • 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
  • 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
  • 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
  • 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.
  • 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
  • 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
  • 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
  • Perceived stress scale [ Time Frame: Up to 12 months ]
    Likert Scale (0: never to 4:very often). Higher scores suggests higher stress
  • 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.
  • 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.
  • 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
  • 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
  • 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.
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE Behavioral Weight Loss Intervention Utilizing Mobile Health Technology in Hematopoietic Stem Cell Transplant Patients (BWL001)
Brief 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. 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Obesity
  • Malignant Neoplasm
Intervention  ICMJE
  • 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
    Other Name: Scale
  • Behavioral: Telephone-Based Intervention
    Receive telephone calls
  • Other: Text Message
    Receive text message
    Other Names:
    • Short Message Service (SMS) Text
    • SMS Text Message
    • Text
Study Arms  ICMJE 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.
Interventions:
  • Other: Interview
  • Other: Media Intervention
  • Other: Questionnaire Administration
  • Other: Scale Device
  • Behavioral: Telephone-Based Intervention
  • Other: Text Message
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 29, 2020)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2023
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 30 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04453072
Other Study ID Numbers  ICMJE 19-001992
NCI-2020-02687 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Jonsson Comprehensive Cancer Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Jonsson Comprehensive Cancer Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE eHealth International, INC.
Investigators  ICMJE
Principal Investigator: Theodore B Moore UCLA / Jonsson Comprehensive Cancer Center
PRS Account Jonsson Comprehensive Cancer Center
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP