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

• ClinicalTrials.gov Identifier: NCT04453072
• Recruitment Status: Recruiting
• First Posted: July 1, 2020
• Last Update Posted: July 7, 2022
• Sponsor: Jonsson Comprehensive Cancer Center
• Collaborator: eHealth International, INC.
• Information provided by (Responsible Party): Jonsson Comprehensive Cancer Center

Tracking Information

• First Submitted Date: June 10, 2020
• First Posted Date: July 1, 2020
• Last Update Posted Date: July 7, 2022
• Actual Study Start Date: July 1, 2020
• Estimated Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

• Obesity
• Malignant Neoplasm

Intervention

• 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

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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 29, 2020): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2023
• Estimated Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 13 Years to 30 Years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04453072
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Jonsson Comprehensive Cancer Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Jonsson Comprehensive Cancer Center
• Original Study Sponsor: Same as current
• Collaborators: eHealth International, INC.

Investigators

• Principal Investigator: Theodore B Moore; UCLA / Jonsson Comprehensive Cancer Center

• PRS Account: Jonsson Comprehensive Cancer Center
• Verification Date: July 2022