MY LIFE Study - McGill Youth Lifestyle Intervention With Food and Exercise Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Body Composition
研究概览
简要总结
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.
详细描述
Rationale: Childhood obesity is an increasingly major health care problem in Canada. Not only are approximately 30% of Canadian children overweight/obese, but they are developing significant sequelae including insulin resistance, hyperinsulinemia, hyperlipidemia, hypertension, and diabetes mellitus. Additionally obese children have lower bone mass, lower 25(OH)D concentrations and fracture more frequently. Canadian children on average do not meet the recommended intakes for vegetables and fruit and only half of those < 8 years old meet the recommended intakes for milk. Obese children are more likely to be inactive and spend more screen-time during their free time. There is promising childhood evidence that diets with 3 to 4 servings of milk support healthier body composition (lean mass and height) and improved insulin sensitivity in the short term and bone mass in the longer term. Family based interventions are effective in weight reduction in children. To date, a combined assessment of the benefits of improved intakes of milk plus active lifestyles in obese children on body composition, bone and blood biochemistry in a family intervention is lacking.
Objectives and Hypotheses:
- To determine if a 1-year lifestyle intervention with planning sessions designed to improve diet and activity within the context of the family environment will reduce adiposity and elevate lean mass while supporting bone mass in obese children compared to a control group and if augmented intake of milk to 4 daily servings will result in superior changes. The primary outcome will be change in body mass index (BMI) Z-score along with waist circumference for assessment of adiposity; selected for ease of use in larger studies or clinics where body composition assessment is not feasible.
Hypothesis: the lifestyle intervention will yield modest changes to adiposity and lean mass accompanied by no reductions in bone mass, but that the augmented milk intervention will yield superior reductions in adiposity and elevations in lean and bone mass and height growth. It is hypothesized that bone mass will be low and that maintenance of bone mass in the standard intervention will thereby be judged as inadequate. 2. To explain the hypothesized benefits of these interventions on lean, adipose and bone masses by measuring indicators of glucose metabolism, satiety and related gut hormones along with novel biomarkers of skeletal metabolism including osteocalcin, adiponectin and vitamin D.
Hypothesis: high milk intake will associate with lower glucose, insulin, ghrelin and 1,25(OH)2D accompanied by higher 25(OH)D, osteocalcin, peptide YY and glucagon-like peptide 1. 3. Test if the intervention with higher milk servings is linked to changes in child eating behavior and satiety using the Child Eating Behavior Questionnaire to reflect eating in the child's normal environment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Body Composition
时间窗: Baseline and following 3, 6, 9 and 12 months of study participation.
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.
次要结局
- 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.)
研究者
Hope Weiler
Associate professor
McGill University
