Clinical trial 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
Official title: Behavioral Weight Loss Intervention Utilizing Mobile Health Technology in Hematopoietic Stem Cell Transplant Patients (BWL001)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Malignant Neoplasm
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: eHealth International, INC.
First posted: 2020-07-01
Enrollment: 20
Sex: ALL
Minimum age (years): 13
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in body mass index (BMI) status
timeFrame: Baseline up to 12 months
Secondary outcomes:
measure: Adherence
timeFrame: Up to 12 months
measure: Fasting lab test analysis: HbA1c
timeFrame: At four months up to 12 months
measure: Fasting lab test analysis: Total cholesterol
timeFrame: At four months up to 12 months
measure: Fasting lab test analysis: Low density lipoprotein
timeFrame: At four months up to 12 months
measure: Fasting lab test analysis: High density lipoprotein
timeFrame: At four months up to 12 months
measure: Fasting lab test analysis: triglycerides
timeFrame: At four months up to 12 months
measure: Fasting lab test analysis: aspartate/alanine aminotransferase
timeFrame: At four months up to 12 months
measure: Fasting lab test analysis: glucose
timeFrame: At four months up to 12 months
measure: Yale Food Addiction Scale
timeFrame: Up to 12 months
measure: Center for epidemiologic studies depression scale
timeFrame: Up to 12 months
measure: Perceived stress scale
timeFrame: Up to 12 months
measure: Satisfaction with program
timeFrame: Up to 12 months
measure: Demographic questionnaire
timeFrame: Up to 12 months
measure: Food craving questionnaire
timeFrame: Up to 12 months
measure: Binge eating disorder screen
timeFrame: Up to 12 months
measure: Physical activity questionnaire
timeFrame: Up to 12 months
measure: S weight
timeFrame: Up to 12 months
measure: Height encounters questionnaire
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA / Jonsson Comprehensive Cancer Center
state: California
Study officials:
affiliation: UCLA / Jonsson Comprehensive Cancer Center
name: Theodore B Moore
role: PRINCIPAL_INVESTIGATOR
References: