Clinical trial
Effects of Whole vs. Nonfat Milk Consumption on Body Composition in Children
Recruiting now · Not applicable · 1 countries · Registry ID NCT05464186
Recruiting nowNot applicableInterventional
What this study is about
This study will evaluate the effects of whole vs. nonfat milk consumption on body composition, cardiometabolic disease risk factors, and dietary quality.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age9 Years to 12 Years
SexAll
Healthy volunteersAccepted
ConditionObesity, Diabetes, Cardiovascular Diseases
Full registry criteria
Inclusion Criteria: * Aged 9 to 12 years * BMI ≥75th percentile for sex and age * Residence in the Greater Boston catchment area Exclusion Criteria: * Aversion to nonfat or whole milk * Physician diagnosis of major medical illness, eating disorder, or milk allergy (lactose intolerance not exclusionary as lactase treated milk can be provided) * Plans to move away from the Greater Boston catchment area during the study period * Plans to be away from home for ≥5 weeks during the study period (e.g., extended summer vacation) * Change in body weight exceeding 10% during prior year * Recent adherence to a special diet * Chronic use of any medication or dietary supplement that could affect study outcomes * Another member of the family (first degree relative) or household participating in the study
Treatments and study arms
Whole milk
Behavioral
Weekly home delivery of whole milk, daily text messages, monthly virtual visits
Nonfat milk
Behavioral
Weekly home delivery of nonfat milk, daily text messages, monthly virtual visits
Primary outcomes
Fat massChange from start of trial (time of randomization) through end of trial (12 months)
Primary outcome for the overall study, main outcome for Specific Aim #1, measured by air displacement plethysmography (BodPod)
Study locations
1 locations were listed when this page was built. The first 40 are shown.
New Balance Foundation Obesity Prevention Center🇺🇸 Boston, Massachusetts, United States
Donna L Lesperance, MA, MPHContact