Plant-Based, American Heart Assoc. or Mediterranean Diets In 9-18 yo With BMI >95%, Cholesterol >169 and Their Parents
Public ClinicalTrials.gov record NCT02857543. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Plant-Based, No-Added-Fat or American Heart Association or Mediterranean Diets a Prospective Randomized Trial: Impact on Cardiovascular Risk in Obese Children With Hypercholesterolemia and in One of Their Parents
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this research is to investigate the effects of a PB no- added-fat and the AHA and MED in obese (BMI \>95%) children ages 9-18 with hypercholesterolemia (\>169 mg/dl) and a parent or guardian. Eligible patients will be identified by utilizing the Pediatric Obesity Registry. When possible, in-person discussions or phone calls with their primary or tertiary care physicians will introduce eligible patients and their parents to the study. All eligible patients and parents will receive letters describing the study and requesting their participation. Subjects can choose not to participate in the study, and their health care will not be affected in any way. Subjects not participating will be asked if they are willing to answer a brief questionnaire about why they chose not to participate. The proposed study will be carried out for a total of 52 weeks. The investigators expect to recruit a total of 180 participants (30 children and 30 parents/guardians in each of the three groups). Each child and parent/guardian pair will be randomly assigned to either PB no-added-fat, AHA or MED.
Study identification
- NCT ID
- NCT02857543
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 180 participants
Conditions and interventions
Conditions
Interventions
- Plant-Based Diet Other
- American Heart Association Diet Other
- Mediterranean Diet Other
Other
Eligibility (public fields only)
- Age range
- 9 Years to 18 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2016
- Primary completion
- Sep 29, 2017
- Completion
- Oct 24, 2021
- Last update posted
- Nov 14, 2021
2016 – 2021
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02857543, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 14, 2021 · Synced Sep 13, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02857543 live on ClinicalTrials.gov.