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Smartphone Weight Loss Coaching for Post-Transplant Weight Loss

N/A

Recruiting

Led By Theodore B Moore

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must classify as obese, represented as body mass index (BMI) >= 85th percentile for age and gender

>= 18 years of age

Must not have

Patients whose BMI does not fall under the obese category will be excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at a weight loss intervention for adolescents and young adults who have had a stem cell transplant. The intervention includes a smartphone app and coaching. Researchers want to see if this helps people lose weight and develop healthy eating habits.

Who is the study for?

This trial is for adolescents and young adults who had a stem cell transplant at least 100 days ago, are obese (BMI >= 85th percentile), can speak and read English. Parents can enroll if their child meets these criteria. No exclusions based on medical conditions, but participation may be limited if health significantly affects intervention engagement.

What is being tested?

The study tests a weight management program using an iPhone app with coaching to help participants lose weight after stem cell transplantation. It aims to see how well the app promotes weight loss and helps develop healthy eating habits in young patients.

What are the potential side effects?

Since this trial involves behavioral interventions like using an app, sending texts, weighing on scales, interviews, phone calls, and questionnaires rather than medication or surgery, it's not expected to have traditional side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My BMI is in the top 15% for my age and gender.

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My BMI is not in the obese range.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in body mass index (BMI) status

Secondary study objectives

Adherence

Binge eating disorder screen

Center for epidemiologic studies depression scale

+15 more

Side effects data

From 2019 Phase 2 trial • 107 Patients • NCT00983580

Tinnitus

Rectal pain

Pain

Hearing test abnormal

Rectal hemorrhage

Dizziness

Gastrointestinal disorder

Headache

Musculoskeletal disorder

100%

80%

60%

40%

20%

Study treatment Arm

Arm I (Acetylsalicylic Acid and Eflornithine)

Arm II (Placebo)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Supportive Care (app, scales, coaching, questionnaire)Experimental Treatment6 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Telephone-Based Intervention

2017

Completed Phase 2

~3400

0 / 3Eligibility criteria met