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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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
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My BMI is in the top 15% for my age and gender.
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I had a stem cell transplant over 100 days ago.
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I am 18 years old or older.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in body mass index (BMI) status
Secondary outcome measures
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)

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
~3360

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
358 Previous Clinical Trials
26,056 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I qualify to participate in this medical study?

"To partake in this trial, potential participants must be aged between 13 and 30 with obesity. The study will accept a total of 20 enrollees."

Answered by AI

How many subjects are being monitored in this research project?

"Affirmative. Clinicaltrials.gov attests that the research trial, which was published on July 1st 2020 and recently edited on July 5th 2022 is actively seeking candidates for enrollment. This medical project requires 20 patients to be enrolled from a single site."

Answered by AI

Is there any availability for individuals to enroll in this research study?

"That is correct. As per the information on clinicaltrials.gov, this research project opened recruitment on July 1st 2020 and was last modified on July 5th 2022. The team managing it requires 20 subjects to be enrolled at one single site."

Answered by AI

Is this medical study available to participants over the age of thirty-five?

"This research project is restricted to people aged between 13 and 30. There are 507 trials focusing on those below the age of majority, while 2879 studies encompass individuals over 65 years old."

Answered by AI
~3 spots leftby Dec 2024