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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-30
SponsorJonsson Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Interview

    Other intervention

    Participate in interviews

  • Media Intervention

    Other intervention

    Receive iPhone with W8Loss2Go app

  • Questionnaire Administration

    Other intervention

    Complete questionnaires

  • Scale Device

    Other intervention

    Receive body scale and food scale

  • Telephone-Based Intervention

    Behavioral

    Receive telephone calls

  • Text Message

    Other intervention

    Receive text message

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Supportive Care (app, scales, coaching, questionnaire)Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

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 outcomes

1

Adherence

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.

Time frame
Up to 12 months
2

Fasting lab test analysis: HbA1c

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%

Time frame
At four months up to 12 months
3

Fasting lab test analysis: Total cholesterol

Total cholesterol: This measures the overall amount of cholesterol in your blood. The healthy range is \< 170 mg/dL

Time frame
At four months up to 12 months
4

Fasting lab test analysis: Low density lipoprotein

LDL: low density lipoprotein (LDL) is the bad cholesterol in your blood. The healthy range is \<100 mg/dL

Time frame
At four months up to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jonsson Comprehensive Cancer Center

Lead sponsor

eHealth International, INC.

Collaborator