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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 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
4%
Tinnitus
2%
Rectal pain
2%
Pain
2%
Hearing test abnormal
2%
Rectal hemorrhage
2%
Dizziness
2%
Gastrointestinal disorder
2%
Headache
2%
Musculoskeletal disorder
100%
80%
60%
40%
20%
0%
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

Find a Location

Who is running the clinical trial?

eHealth International, INC.UNKNOWN
1 Previous Clinical Trials
46 Total Patients Enrolled
Jonsson Comprehensive Cancer CenterLead Sponsor
370 Previous Clinical Trials
35,174 Total Patients Enrolled
Theodore B MoorePrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center

Media Library

iPhone Weight Management App Clinical Trial Eligibility Overview. Trial Name: NCT04453072 — N/A
Obesity Research Study Groups: Supportive Care (app, scales, coaching, questionnaire)
Obesity Clinical Trial 2023: iPhone Weight Management App Highlights & Side Effects. Trial Name: NCT04453072 — N/A
iPhone Weight Management App 2023 Treatment Timeline for Medical Study. Trial Name: NCT04453072 — N/A
~1 spots leftby Dec 2024
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