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Behavioral Intervention
Mobile Integrated Care for Childhood Obesity
N/A
Recruiting
Led By Thao-Ly T Phan, MD, MPH
Research Sponsored by Nemours Children's Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial will evaluate a new program to help kids with unhealthy weight by providing check-ins, a mobile app, and community activities. #health #children #weightloss
Who is the study for?
This trial is for children aged 4-12 with obesity, who are patients at specific Nemours Children's Health clinics in rural areas. They must have a BMI ≥ 95% for their age and sex. Kids can't join if they have certain genetic or endocrine disorders, take weight-affecting meds, or if the caregiver isn't their legal guardian or doesn't speak English/Spanish.Check my eligibility
What is being tested?
The study compares two approaches to help kids with unhealthy weight: standard care versus a Healthy Lifestyle program that includes specialist check-ins, a mobile app for lifestyle support, and community activities. The aim is to see which group shows better weight outcomes and retention rates.See study design
What are the potential side effects?
There may not be direct side effects from participating; however, changes in diet and activity levels as advised by healthcare providers could lead to temporary discomfort like muscle soreness or dietary adjustments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in child adiposity
Visit adherence
Secondary outcome measures
Differences in change in child adiposity based on child sociodemographic characteristics
Differences in visit adherence based on child sociodemographic characteristics
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Healthy LifestyleExperimental Treatment1 Intervention
Healthy lifestyle counseling and goal setting every month with a team of experts, mobile app with healthy lifestyle resources and goal tracking tool, access to social services and lifestyle programs in the community, and community health worker outreach every month.
Group II: Standard of CareActive Control1 Intervention
Weight checks and lifestyle counseling with primary care provider every other month.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Healthy Lifestyle
2014
N/A
~400
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Who is running the clinical trial?
Nemours Children's Health SystemLead Sponsor
9 Previous Clinical Trials
17,247 Total Patients Enrolled
1 Trials studying Obesity
120 Patients Enrolled for Obesity
National Institute of General Medical Sciences (NIGMS)NIH
269 Previous Clinical Trials
246,928 Total Patients Enrolled
14 Trials studying Obesity
1,516 Patients Enrolled for Obesity
Thao-Ly T Phan, MD, MPHPrincipal InvestigatorNemours Children's Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My child is between 4 and 12 years old.My caregiver does not speak English or Spanish well.My child's BMI is in the top 5% for their age and sex.My child is on medication that affects their weight.My child has a genetic condition or hormone disorder linked to obesity.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care
- Group 2: Healthy Lifestyle
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals have enrolled in this medical exploration?
"Affirmative. The information found on clinicaltrials.gov reveals that this medical experiment is presently enrolling patients, first posted on July 26th 2023 and most recently updated August 16th of the same year. A grand total of 184 individuals are required to be recruited from 3 separate trial sites."
Answered by AI
Does this medical research project currently accept new participants?
"That is accurate. Clinicaltrials.gov reveals that this trial, first listed on July 26th 2023, is actively searching for 184 individuals to partake across 3 sites."
Answered by AI
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