Clinical trial NCT03914807: Cow Milk Fat Obesity pRevention Trial
Official title: Cow Milk Fat Obesity pRevention Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity, Childhood
Keywords: milk
fat
cohort-embedded
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Unity Health Toronto
First posted: 2019-04-16
Enrollment: 534
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Superiority cohort embedded 2 arm pragmatic randomized controlled trial
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: weight
timeFrame: Measured 24 months post-study entry
measure: height
timeFrame: Measured 24 months post-study entry
measure: body mass index z-score (zBMI)
timeFrame: Measured 24 months post-study entry
Secondary outcomes:
measure: serum 25-hydroxyvitamin D
timeFrame: Measured 24 months post-study entry
measure: serum glucose
timeFrame: measured 24 months post-study entry
measure: blood pressure
timeFrame: measured 24 months post-study entry
measure: serum insulin
timeFrame: measured 24 months post-study entry
measure: serum triglycerides
timeFrame: measured 24 months post-study entry
measure: serum total cholesterol
timeFrame: measured 24 months post-study entry
measure: serum high density lipoprotein cholesterol
timeFrame: measured 24 months post-study entry
measure: serum low density lipoprotein cholesterol
timeFrame: measured 24 months post-study entry
measure: serum non-high density lipoprotein cholesterol
timeFrame: measured 24 months post-study entry
measure: serum highly sensitive c-reactive protein
timeFrame: measured 24 months post-study entry
measure: height z-score
timeFrame: measured 24 months post-study entry
measure: waist circumference
timeFrame: measured 24 months post-study entry
measure: lean body mass
timeFrame: measured 24 months post-study entry
measure: fat mass
timeFrame: measured 24 months post-study entry
measure: school readiness
timeFrame: measured 24 months post-study entry
measure: cognitive development
timeFrame: measured 24 months post-study entry
measure: dietary intake
timeFrame: measured 24 months post-study entry
measure: carotid intima media thickness (cIMT)
timeFrame: measured 24 months post-study entry
measure: restrained and emotional eating
timeFrame: measured 24 months post-study entry
measure: nutritional risk
timeFrame: measured 24 months post-study entry
measure: physical activity (minutes per day)
timeFrame: measured 24 months post-study entry
measure: sleep time (hours per night)
timeFrame: measured 24 months post-study entry
measure: healthcare service utilization
timeFrame: measured 24 months post-study entry
measure: upper respiratory tract infection incidence
timeFrame: measured 24 months post-study entry
measure: growth trajectories
timeFrame: measured 24 months post-study entry
measure: head circumference
timeFrame: measured 24 months post-study entry
measure: cost effectiveness
timeFrame: measured 24 months post-study entry
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Jonathon L Maguire, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.