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NCT Number: 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

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.

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Key information

Conditions

Obesity Body Weight Malignant Neoplasm Neoplasms Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

13 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location status: Recruiting

Location contact

Theodore B. Moore

CONTACT

[email protected]

310-794-8929

Theodore B. Moore

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

interview

Other

Participate in interviews

Media Intervention

Other

Receive iPhone with W8Loss2Go app

Questionnaire Administration

Other

Complete questionnaires

Scale Device

Other

Receive body scale and food scale

Other names: Scale

Telephone-Based Intervention

Behavioral

Receive telephone calls

Text message

Other

Receive text message

Other names: Short Message Service (SMS) Text, SMS Text Message, Text

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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%

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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

  9. 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

  10. 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

  11. Perceived stress scale

    Time frame: Up to 12 months

    Likert Scale (0: never to 4:very often). Higher scores suggests higher stress

  12. 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.

  13. 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.

  14. 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

  15. 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

  16. 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.

  17. 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

  18. 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.

Sponsors and collaborators

Lead sponsor

Jonsson Comprehensive Cancer Center

Other

Collaborators

  • eHealth International, INC.

Registry information

Official study title

Behavioral Weight Loss Intervention Utilizing Mobile Health Technology in Hematopoietic Stem Cell Transplant Patients (BWL001)

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Jul 1, 2020
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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