Youth Lifestyle Intervention With Food and Exercise
MYLIFE
MY LIFE Study - McGill Youth Lifestyle Intervention With Food and Exercise Study
1 other identifier
interventional
132
1 country
1
Brief Summary
Children who are overweight or obese can develop many health complications including diabetes, high blood pressure, high cholesterol and they break their bones more often than children who are of healthy body weights. Recent short-term studies in children suggest that increasing milk intake for 16 weeks begins to improve body composition and also reduces risk of developing diabetes. However, no study has been long enough to truly test for the benefits of high milk consumption on these conditions including bone. Both dietary and activity approaches to reducing obesity in children are suggested by health professionals and when combined are called lifestyle interventions. Therefore, McGill University has designed a 1-year intervention study focused on lifestyle improvements to reduce obesity in children 6 to 12 years of age. A control group will be monitored for the year, while two other groups will receive lifestyle interventions with standard recommended (2 servings a day) and high (4 servings a day) intakes of milk. The intervention will include 6 planning sessions to increase intakes of vegetables, fruits and milks along with more activity and less time watching television or using computerized games. Children will have muscle and fat measured using an x-ray device that also measures bone at the beginning, middle and end of the study. They will also have a small blood sample taken every 3 months to measure blood sugar, cholesterol and some nutrients. Changes over the study will demonstrate the benefits of lifestyle and milk interventions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy
Started Dec 2010
Longer than P75 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 1, 2011
CompletedFirst Posted
Study publicly available on registry
February 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedApril 8, 2015
April 1, 2015
3.4 years
February 1, 2011
April 7, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Body Composition
Lean mass and fat mass will be measured using a Hologic 4500A dual x-ray absorptiometry machine (DXA). For this test, children will wear standardized clothing (pyjama bottoms and T-shirt). These measures are rapid, taking a total of 5 minutes x-ray time and the low radiation (\<10 uSV) will not exceed limits for x-ray exposure.
Baseline and following 3, 6, 9 and 12 months of study participation.
Secondary Outcomes (3)
Blood Biochemistry
Baseline and following 3, 6, 9 and 12 months of study participation.
Satiety Scores
Following 12 months of study participation.
Bone Mass
Baseline and following 3, 6, 9 and 12 months of study participation.
Study Arms (5)
Control 6-8 yrs
ACTIVE COMPARATORThe group will receive information during the study about diet and exercise but will not receive the intervention till the end of the study protocol.
2 servings dairy + exercise 6-8 yrs
EXPERIMENTALSubjects in this group will receive family based counseling to maintain the intake of 2 servings of dairy per day and also receive instruction on how to improve their physical activity.
4 servings dairy + exercise 6-8 yrs
EXPERIMENTALSubjects in this group will receive family based counselling to maintain the intake of 4 servings of dairy per day and also receive instruction on how to improve their physical activity.
4 servings dairy + exercise 9-12 yrs
EXPERIMENTALSubjects in this group will receive family based counselling to maintain the standard recommended intake of 4 servings of dairy per day for 9-14 year olds according to the Canada's Food Guide and also receive instruction on how to improve their physical activity.
Control 9-12 yrs
ACTIVE COMPARATORThe group will receive information during the study about diet and exercise but will not receive the intervention until 6 months into the study protocol.
Interventions
Subjects in this group will receive family based counseling to maintain the intake of 2 servings of dairy per day and also receive instruction on how to improve their physical activity.
Subjects in this group will receive family based counseling to increase intake of dairy to 4 servings per day and also receive instruction on how to improve their physical activity.
The group will receive information during the study about diet and exercise but will not receive the intervention until 6 months into the study protocol.
Eligibility Criteria
You may qualify if:
- Participants must be between 6 and 12 years of age at onset of the intervention
- Consume \< 2 servings of milk and milk products but be receptive to the recommendations
- Have body mass index (BMI) over the 97 percentile for age and sex according to the World Health Organization. The Canadian Community Health Survey (CCHS)assessment of obesity used the definition by the International Obesity Task Force. This yields similar results as when using BMI percentile cut-offs proposed by the World Health Organization (WHO) for all ages of children. The WHO now has reference data available to 19 years of age. The BMI values at the 97th percentile are lower compared to the 2000 Centres for Disease Control charts (http://www.who.int/growthref/who2007\_bmi\_for\_age/en/index.html).
You may not qualify if:
- Known or suspected serious, chronic illness of childhood, such as cancer, Crohn's disease, nephrotic syndrome, rheumatic conditions, and diabetes, etc., or those with disturbances in bone, vitamin D or mineral ion metabolism including rickets, osteomalacia, liver disease, renal disease, immobilization (complete or partial), current fractures, and disorders of the parathyroid gland.
- Use in the past 3 months, medications known to affect bone and/or mineral ion metabolism including all glucocorticoids, phosphate therapy or vitamin D analogues and any bisphosphonates.
- Severe anemia precluding blood sampling (previously diagnosed).
- Established diabetes mellitus (any type). Use of a glucometer and finger lance will confirm.
- Hyperlipidemia ascribed to non-dietary causes.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- McGill Universitylead
- Dairy Farmers of Canadacollaborator
Study Sites (1)
Mary Emily Clinical Nutrition Research Unit of McGill University
Sainte-Anne-de-Bellevue, Quebec, H9X 2E3, Canada
Related Publications (4)
Cohen TR, Mak IL, Loiselle SE, Kasvis P, Hazell TJ, Vanstone CA, Rodd C, Weiler HA. Changes in Adiposity without Impacting Bone Health in Nine- to Twelve-Year-Old Children with Overweight and Obesity after a One-Year Family-Centered Lifestyle Behavior Intervention. Child Obes. 2023 Jan;19(1):46-56. doi: 10.1089/chi.2022.0008. Epub 2022 Apr 5.
PMID: 35384736DERIVEDCohen TR, Hazell TJ, Vanstone CA, Rodd C, Weiler HA. Bone Health is Maintained, While Fat Mass is Reduced in Pre-pubertal Children with Obesity Participating in a 1-Year Family-Centered Lifestyle Intervention. Calcif Tissue Int. 2017 Dec;101(6):612-622. doi: 10.1007/s00223-017-0318-8. Epub 2017 Sep 2.
PMID: 28866763DERIVEDHazell TJ, Ellery CV, Cohen TR, Vanstone CA, Rodd CJ, Weiler HA. Assessment of pedometer accuracy in capturing habitual types of physical activities in overweight and obese children. Pediatr Res. 2016 Nov;80(5):686-692. doi: 10.1038/pr.2016.133. Epub 2016 Jun 24.
PMID: 27486704DERIVEDCohen TR, Hazell TJ, Vanstone CA, Plourde H, Rodd CJ, Weiler HA. A family-centered lifestyle intervention to improve body composition and bone mass in overweight and obese children 6 through 8 years: a randomized controlled trial study protocol. BMC Public Health. 2013 Apr 25;13:383. doi: 10.1186/1471-2458-13-383.
PMID: 23617621DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hope A Weiler, PhD, RD
McGill University
- PRINCIPAL INVESTIGATOR
Celia Rodd, MD
Montreal Children's Hospital of the MUHC
- PRINCIPAL INVESTIGATOR
Hugues Plourde, RD, PhD
McGill University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
February 1, 2011
First Posted
February 4, 2011
Study Start
December 1, 2010
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
April 8, 2015
Record last verified: 2015-04