Cow Milk Fat Obesity pRevention Trial (CoMFORT)

The Hospital for Sick Children

Status

Enrolling

Conditions

Obesity, Childhood

Treatments

Other: Reduced (1%) fat milk

Other: Whole (3.25%) cow's milk recommendation

Study type

Interventional

Funder types

Other

Identifiers

NCT03914807

18-369

Details and patient eligibility

About

Cow's milk is a dietary staple for children in North America. Though clinical guidelines suggest children transition from whole (3.25% fat) milk to reduced (1%) fat milk at age 2 years, recent epidemiological evidence supports a link between whole milk consumption and lower adiposity in children. The purpose of this trial is to determine which milk fat recommendation minimizes excess adiposity and optimizes child nutrition and development. CoMFORT will be a parallel group randomized controlled trial among children aged 2 to 4 years participating in the TARGet Kids! practice-based research network. Children will be randomized to receive one of two usual care nutritional recommendations: 1) a recommendation to consume whole milk, or 2) a recommendation to consume reduced (1%) fat milk. The primary outcome is Body Mass Index z-score (zBMI); secondary outcomes will be cognitive development (using the Ages and Stages Questionnaire), vitamin D stores (serum 25-hydroxyvitamin D), cardiometabolic health (glucose, hsCRP, non-HDL, LDL, triglyceride, HDL and total cholesterol, insulin, and diastolic and systolic blood pressure) and sugar sweetened beverage intake (measured by 24-hour dietary recall). Outcomes will be measured 24 months post-randomization and compared using ANCOVA, adjusting for baseline measures. This trial will contribute to nutrition policy for children in effort to reduce childhood obesity using a simple, inexpensive and scalable cow's milk fat intervention.

Enrollment

534 estimated patients

Sex

All

Ages

18 to 60 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

healthy by parental report;
1.5 to 2.99 years of age
involved in a TARGet Kids! academic pediatric or family medicine group.

Exclusion criteria

Prader-Willi syndrome or other syndrome associated with obesity
severe development delay
children who are from families without verbal communication in English or French
failure to thrive (with zBMI values ≤ -2 are unlikely to benefit from obesity prevention)
siblings of trial participants as families may share milk
will not consume cow's milk by choice, lactose intolerance or allergy.