Youth Lifestyle Intervention With Food and Exercise - Full Text View

Purpose

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.

Condition	Intervention
Healthy Obesity	Behavioral: 2 servings of dairy and exercise counselling Behavioral: 4 servings of dairy and exercise counselling

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	MY LIFE Study - McGill Youth Lifestyle Intervention With Food and Exercise Study

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Exercise and Physical Fitness Obesity

U.S. FDA Resources

Further study details as provided by McGill University:

Primary Outcome Measures:

Body Composition [ Time Frame: Baseline and following 3, 6, 9 and 12 months of study participation. ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Blood Biochemistry [ Time Frame: Baseline and following 3, 6, 9 and 12 months of study participation. ] [ Designated as safety issue: No ]
Blood samples will be drawn to examine their associations with the intervention. Analytes will include vitamin D, glucose, insulin, iron, calcium, blood lipids.
Satiety Scores [ Time Frame: Following 12 months of study participation. ] [ Designated as safety issue: No ]
This score will evaluate the effectiveness of the intervention on satiety. Subjects fill out a questionnaire validated in children.
Bone Mass [ Time Frame: Baseline and following 3, 6, 9 and 12 months of study participation. ] [ Designated as safety issue: No ]
Bone mass (whole body, lumbar spine vertebrae 1 to 4, hip bone mass and forearm) will be measured using a Hologic 4500A clinical densitometer (dual x-ray absorptiometry (DXA)). For this test, children will wear standardized clothing (pajama 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.

Estimated Enrollment:	150
Study Start Date:	December 2010
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Control 6-8 years The group will receive information during the study about diet and exercise but will not receive the intervention till the end of the study protocol.	Behavioral: 2 servings of dairy and exercise counselling 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. Other Name: 2 servings of dairy and exercise
Experimental: 2 servings of dairy and exercise 6-8 years 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.	Behavioral: 2 servings of dairy and exercise counselling 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. Other Name: 2 servings of dairy and exercise
Experimental: 4 servings of dairy and exercise 6-8 years Subjects 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.	Behavioral: 4 servings of dairy and exercise counselling 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. Other Name: 4 servings of dairy and exercise
Experimental: 4 servings of dairy and exercise 9-12 years Subjects 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.	Behavioral: 4 servings of dairy and exercise counselling 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. Other Name: 4 servings of dairy and exercise
Active Comparator: Control 9-12 years 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.	Behavioral: 4 servings of dairy and exercise counselling 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. Other Name: 4 servings of dairy and exercise

Show Detailed Description

Eligibility

Ages Eligible for Study:	6 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01290016

Locations

Canada, Quebec
Mary Emily Clinical Nutrition Research Unit of McGill University
Sainte Anne-de-Bellevue, Quebec, Canada, H9X 2E3

Sponsors and Collaborators

McGill University

Dairy Farmers of Canada

Investigators

Principal Investigator:	Hope A Weiler, PhD, RD	McGill University
Principal Investigator:	Celia Rodd, MD	Montreal Children's Hospital
Principal Investigator:	Hugues Plourde, RD, PhD	McGill University

More Information

No publications provided

Responsible Party:	Hope Weiler, Associate professor, McGill University
ClinicalTrials.gov Identifier:	NCT01290016 History of Changes
Other Study ID Numbers:	HW-10-03
Study First Received:	February 1, 2011
Last Updated:	May 30, 2013
Health Authority:	Canada: Health Canada

Keywords provided by McGill University:

randomized controlled trial
children
obesity
nutrition
exercise

Additional relevant MeSH terms:

Obesity
Overnutrition
Nutrition Disorders

Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013

Youth Lifestyle Intervention With Food and Exercise (MYLIFE)