Cow Milk Fat Obesity pRevention Trial

NCT ID: NCT03914807

Last Updated: 2023-12-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 534 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2025-06-01

Brief Summary

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.

Conditions

Obesity, Childhood

Keywords

milk; fat; cohort-embedded

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Whole (3.25%) milk

Group Type: ACTIVE_COMPARATOR

Whole (3.25%) cow's milk recommendation

Intervention Type: OTHER

Children randomized to the whole milk recommendation will receive a recommendation a primary care recommendation to consume 500 mL of whole fat (3.25%) milk instead of transitioning to reduced fat (1%) milk at 2 years of age. The primary care physician will verbally make this recommendation during the recruitment well-child visit. Parents will also be reminded bi-monthly by phone calls made by a research assistant. Children in the whole milk recommendation group will be provided with the same age-appropriate nutritional recommendations as children in the reduced fat recommendation group as part of routine healthcare according to the Rourke Baby Record.

Reduced fat (1%) milk

Group Type: ACTIVE_COMPARATOR

Reduced (1%) fat milk

Intervention Type: OTHER

Children randomized to the reduced fat group will receive a primary care recommendation to transition from whole milk to 500 mL reduced fat (1%) milk daily once the child is two years of age (consistent with current guidelines). The physician will verbally make this recommendation during the recruitment well-child visit. Parents will also be reminded bi-monthly by phone calls made by a research assistant. Children who receive the reduced fat recommendation will be provided with the same age-appropriate nutritional recommendations as children who receive the whole fat recommendation as part of routine healthcare according to the Rourke Baby Record.

Interventions

Whole (3.25%) cow's milk recommendation

Children randomized to the whole milk recommendation will receive a recommendation a primary care recommendation to consume 500 mL of whole fat (3.25%) milk instead of transitioning to reduced fat (1%) milk at 2 years of age. The primary care physician will verbally make this recommendation during the recruitment well-child visit. Parents will also be reminded bi-monthly by phone calls made by a research assistant. Children in the whole milk recommendation group will be provided with the same age-appropriate nutritional recommendations as children in the reduced fat recommendation group as part of routine healthcare according to the Rourke Baby Record.

Intervention Type: OTHER

Reduced (1%) fat milk

Children randomized to the reduced fat group will receive a primary care recommendation to transition from whole milk to 500 mL reduced fat (1%) milk daily once the child is two years of age (consistent with current guidelines). The physician will verbally make this recommendation during the recruitment well-child visit. Parents will also be reminded bi-monthly by phone calls made by a research assistant. Children who receive the reduced fat recommendation will be provided with the same age-appropriate nutritional recommendations as children who receive the whole fat recommendation as part of routine healthcare according to the Rourke Baby Record.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 60 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Unity Health Toronto

OTHER

Sponsor Role: collaborator

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Jonathon L Maguire

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathon L Maguire, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

St. Michael's Hospital

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Jonathon L Maguire, MD, FRCPC

Role: CONTACT

Phone: (416) 867-3655

Email: jonathon.maguire@utoronto.ca

Facility Contacts

Jonathon L Maguire, MD, FRCPC

Role: primary

References

Vanderhout SM, Aglipay M, Birken C, Li P, O'Connor DL, Thorpe K, Constantin E, Davis MA, Feldman M, Ball GDC, Janus M, Juni P, Junker A, Laupacis A, L'Abbe M, Manson H, Moretti ME, Persaud N, Omand JA, Relton C, Wong P, Yamashiro H, Tavares E, Weir S, Maguire JL. Cow's Milk Fat Obesity pRevention Trial (CoMFORT): a primary care embedded randomised controlled trial protocol to determine the effect of cow's milk fat on child adiposity. BMJ Open. 2020 May 7;10(5):e035241. doi: 10.1136/bmjopen-2019-035241.

Reference Type: DERIVED

PMID: 32385063 (View on PubMed)

Other Identifiers

18-369

Identifier Type: -

Identifier Source: org_study_id