Status:
COMPLETED
Childhood Obesity Microbiome Study
Lead Sponsor:
Duke University
Conditions:
Pediatric Obesity
Eligibility:
All Genders
6-11 years
Phase:
NA
Brief Summary
The purpose of this study is to measure the effectiveness of a microbiome diet using direct food provision on dietary quality and microbiome composition among children with obesity. This study propose...
Detailed Description
Childhood obesity is a global health crisis and contributes to shortened life expectancy in the US, with higher rates and more serious co-morbidities among minorities. Existing dietary interventions d...
Eligibility Criteria
Inclusion
- Child aged 6 - 11 years (not yet aged 12)
- Child with BMI ≥ 95th percentile
- Parents are willing to accept home deliveries and have the ability to be home at the time and day that is most convenient for them to receive the groceries; or, have transportation available to go and pick up groceries at a time and date that is most convenient for them at a Walmart location.
Exclusion
- Does the child have a current diagnosis of obesity due to an underlying condition such as hypothyroidism, Cushing's disease, or known genetic condition?
- Is the child currently taking any weight-loss medication (steroids, anti-psychotics, anti-depressants)
- Has the child started a stimulant medication in the past 3 months? (stimulants include, among others, Ritalin, Adderall, concerta, focalin, vyvanse).
- Is the child currently taking, or has taken in the past 4 weeks, an antibiotic?
- Is the child currently taking, or plans to take in the next 4 weeks, a weight loss medication?
- Is the patient on a pharmacotherapy or weight loss surgery track in Healthy Lifestyless?
- Has the patient lost more than 5% of their body weight in the preceding 6 months?
Key Trial Info
Start Date :
April 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2021
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT04770311
Start Date
April 9 2021
End Date
November 20 2021
Last Update
April 15 2022
Active Locations (1)
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1
Duke Healthy Lifestyles Roxboro Street
Durham, North Carolina, United States, 27704