At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating Plant-Based Diet, American Heart Association Diet, and 1 other intervention for Obesity and 2 related conditions. Completed, enrolled 180 participants across 1 site.
Detailed Summary
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.