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

NCT ID: NCT04453072Sponsor: Jonsson Comprehensive Cancer CenterLast updated: 2026-05-11

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.

Arms & interventions

  • OtherInterview

    Participate in interviews

  • OtherMedia Intervention

    Receive iPhone with W8Loss2Go app

  • OtherQuestionnaire Administration

    Complete questionnaires

  • OtherScale Device

    Receive body scale and food scale

  • BehavioralTelephone-Based Intervention

    Receive telephone calls

  • OtherText Message

    Receive text message

Outcome measures

Primary

  • 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.

    Time frame: Baseline up to 12 months

Secondary

  • 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

  • Demographic questionnaire

    Time frame: Up to 12 months

  • Food craving questionnaire

    Time frame: Up to 12 months

  • Binge eating disorder screen

    Time frame: Up to 12 months

  • Physical activity questionnaire

    Time frame: Up to 12 months

  • S weight

    Time frame: Up to 12 months

  • Height encounters questionnaire

    Time frame: Up to 12 months

Eligibility criteria

Sex: AllAge: 13 Years to 30 YearsHealthy volunteers: Yes
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

Study locations (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095

Recruiting
Theodore B. Moore · Contact
310-794-8929tbmoore@mednet.ucla.edu
Theodore B. Moore · Principal Investigator