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Behavioral Intervention
Treatment for Dyslipidemia (MODIFY Trial)
N/A
Waitlist Available
Led By Michele Mietus-Snyder, MD
Research Sponsored by Children's National Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged 10 years to 18 years Dyslipidemia (TG/HDL-c >2.5 in non-Black males and >2.0 in females and Black males) Central adiposity (waist to height ratio > 0.5) Willingness to participate
Parent or adult caregiver of adolescent patient Central adiposity (waist to height ratio >0.5) Willingness to participate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline level at 2 months
Awards & highlights
MODIFY Trial Summary
This trial will test whether plasma ceramides can be used as early nutrition-sensitive biomarkers of metabolic health, by implementing a diet and lifestyle intervention to improve cardiometabolic risk factors, and measuring the corresponding change in Cer levels.
Eligible Conditions
- Dyslipidemia
- Obesity
MODIFY Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowMODIFY Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline level of plasma ceramides at 2 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline level of plasma ceramides at 2 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 plasma ceramides
Secondary outcome measures
Change in BMI
Change in diet
Change in physical activity
+5 moreOther outcome measures
Mental health
MODIFY Trial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Participants will be asked use a mobile health (m-health) app for 2 months. The app is designed to provide weekly education and motivation about healthful diet and physical activity behaviors in adolescents and their parent/adult caretaker. Both adolescent and parent/adult caretaker participants will use the app to enter weekly self-report data, set healthy eating and exercise goals, and receive educational and motivational content. Participants will conduct a weekly self-assessment of waist circumference, diet, and physical activity during the 2 month trial.
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Who is running the clinical trial?
Children's National Research InstituteLead Sponsor
209 Previous Clinical Trials
207,723 Total Patients Enrolled
University of California, DavisOTHER
908 Previous Clinical Trials
4,704,093 Total Patients Enrolled
4 Trials studying Dyslipidemia
287 Patients Enrolled for Dyslipidemia
NutritionQuestUNKNOWN
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies in this clinical trial for prospective participants?
"Data on clinicaltrials.gov reveals that this medical study, which opened its doors to applicants on September 29th 2020, is not actively recruiting any longer. At present time there are 1,004 other trials now in search of participants."
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