Assessment of Risk Factors for Childhood Obesity and the Impact of a Nutrition-based Educational Intervention on Infant Feeding, Growth and Body Composition
试验速览
- 阶段
- 不适用
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Child's fat mass and lean mass (body composition) determined using Bioelectrical Impedance Analysis (BIA) - second assessment
研究概览
简要总结
The period from conception to 2 years of age ('first 1000 days') has been recognized as a critical period for long-lasting programming effects on later obesity and associated NCD and a window of opportunity to implement intervention for reducing and treating childhood obesity. However, there is a dearth of prospective intervention studies that address this nutritional problem in Jamaica and there are no reports of sustainable intervention.
Jamaica is a middle income country in which overweight and obesity in children are also increasing at an alarming rate. The investigators in Jamaica are seeking to provide a more comprehensive knowledge on the link between early life nutrition and later childhood health and to assess the impact of an intervention of infant feeding counselling/education in mothers on growth and body composition in their offspring.
详细描述
At least 41 million children younger than 5 years are overweight or obese most of whom reside in low-income and middle-income countries (LMIC). Obese children tend to remain obese in adulthood predisposing to the huge personal health and economic burden of the non-communicable diseases (NCD).
Several early life factors identified to contribute to development of obesity and adverse metabolic profile; pre-pregnancy underweight and overweight, high weight gain in early pregnancy in addition to inappropriate infant feeding pattern and rapid weight gain in early life have major role.
The aims of the study are:1) to assess intrauterine and postnatal risk factors for childhood obesity in children followed from the second trimester in mother's pregnancy to age 1 year and 2) to assess the impact of a nutrition-based educational intervention on infant feeding, growth and body composition in the first year of life.
This study design is a cluster randomized clinical trial with key outputs being : 1) The use of deuterium dilution method to provide new data on body composition of mothers from during pregnancy and during infancy in addition to obtain accurate measurement of breastmilk intake 2) new data on the relationship between maternal body composition and/or infant body composition and non-communicable disease risk factors; 3) new data on the impact of a nutrition-based educational on infant's growth and body composition.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Women (18-40 years)
- •Women 30 -32 weeks gestation
- •First or second pregnancy
- •Healthy term infants ( > 37 completed weeks)
- •Infants with birthweight >2.5kg)
排除标准
- •Pre-gestational diabetes
- •Pre-gestational hypertension
- •Sickle cell disease
- •HIV infection,
- •Psychiatric disorder
- •Gestational diabetes
- •Infants with congenital abnormalities
- •Infants with chromosomal disorders
- •Infants admitted in neonatal period > 48 hours
结局指标
主要结局
Child's fat mass and lean mass (body composition) determined using Bioelectrical Impedance Analysis (BIA) - second assessment
时间窗: 12 months old
Child's fat mass and lean mass (body composition) determined using a Bioelectrical Impedance Analyzer
Feeding Questionnaire - fourth assessment
时间窗: 6 months old
This questionnaire will describe breastfeeding and complementary feeding practices. Proportions will be used to compare responses between the intervention and control groups. A scale will not be used.
Child's weight in kilograms - first assessment
时间窗: 4 weeks old
Child's weight measured using a digital scale
Child's fat mass and lean mass (body composition) determined using Air Displacement Plethysmography - first assessment
时间窗: 4 weeks old
Measurement of child's fat mass and lean mass (body composition) using the Air Displacement Plethysmography
Child's mid-upper arm circumference - first assessment
时间窗: 6 months
Child's mid-upper arm circumference measured using a tape measure
Child's lean mass and fat mass (body composition) determined using skin fold measurements - second assessment
时间窗: 12 months old
Child's fat mass and lean mass (body composition) determined using skin fold callipers
Child's weight in kilograms - second assessment
时间窗: 3 months old
Child's weight measured using a digital scale
Feeding Questionnaire - first assessment
时间窗: 2 weeks old
This questionnaire will describe breastfeeding and complementary feeding practices. Proportions will be used to compare responses between the intervention and control groups. A scale will not be used.
Feeding Questionnaire - third assessment
时间窗: 3 months old
This questionnaire will describe breastfeeding and complementary feeding practices. Proportions will be used to compare responses between the intervention and control groups. A scale will not be used.
Feeding Questionnaire - fifth assessment
时间窗: 12 months old
This questionnaire will describe breastfeeding and complementary feeding practices. Proportions will be used to compare responses between the intervention and control groups. A scale will not be used.
Child's lean mass and fat mass (body composition) determined using skin fold measurements - first assessment
时间窗: 6 months old
Child's fat mass and lean mass (body composition) determined using skin fold callipers
Child's length in centimeters - first assessment
时间窗: 4 weeks old
Child's length measured using a stadiometer
Child's fat mass and lean mass (body composition) determined using Dual-energy X-ray absorptiometry (DEXA)
时间窗: 12 months old
A whole body DEXA scan will be done as described by the International Atomic Energy Agency. A scan takes about 7 minutes.
Child's fat mass and lean mass (body composition) determined using the Air Displacement Plethysmography - second assessment
时间窗: 3 months old
Measurement of child's fat mass and lean mass (body composition) using the Air Displacement Plethysmography
Feeding Questionnaire - second assessment
时间窗: 4 weeks old
This questionnaire will describe breastfeeding and complementary feeding practices. Proportions will be used to compare responses between the intervention and control groups. A scale will not be used.
Child's fat mass and lean mass (body composition) determined using Bioelectrical Impedance Analysis (BIA) - first assessment
时间窗: 6 months old
Child's fat mass and lean mass (body composition) determined using a Bioelectrical Impedance Analyzer
Child's mid-upper arm circumference - second assessment
时间窗: 12 months old
Child's mid-upper arm circumference measured using a tape measure
Child's weight in kilograms - third assessment
时间窗: 6 months old
Child's weight measured using a digital scale
Child's fat mass and lean mass (body composition) determined using deuterium dilution method - first assessment
时间窗: 6 months old
Measurement of fat mass and lean mass (body composition) using the deuterium dilution method
Child's fat mass and lean mass (body composition) determined using deuterium dilution method - second assessment
时间窗: 12 months old
Measurement of fat mass and lean mass (body composition) using the deuterium dilution method
Child's weight in kilograms - fourth assessment
时间窗: 12 months old
Child's weight measured using a digital scale
Child's length in centimeters - second assessment
时间窗: 3 months old
Child's length measured using a stadiometer
Child's length in centimeters - third assessment
时间窗: 6 months old
Child's length measured using a stadiometer
Child's length in centimeters - fourth assessment
时间窗: 12 months old
Child's length measured using a stadiometer
Child's fat mass and lean mass (body composition) determined using the Air Displacement Plethysmography - third assessment
时间窗: 6 months old
Measurement of child's fat mass and lean mass (body composition) using the Air Displacement Plethysmography
次要结局
- mother's weight - third assessment(12 months post natally)
- Mother's weight - first assessment(30-32 weeks gestation)
- Mother's height(30-32 weeks gestation)
- Mother's fat mass and lean mass (body composition) determined using skin fold measurements - second assessment(3 months post natally)
- Mother's fat mass and lean mass (body composition) determined using skin fold measurements - third assessment(12 months post natally)
- Screen time / sleep time questionnaire - third assessment(12 months old)
- Breastmilk intake in child(3 months old)
- Mother's mid-upper arm circumference - first assessment(30-32 weeks gestation)
- Mother's fat mass and lean mass (body composition) determined using Bioelectrical Impedance Analysis (BIA) - second assessment(3 months post natally)
- mother's weight - second assessment(3 months post natally)
- mother's mid-upper arm circumference - second assessment(3 months post natally)
- mother's mid-upper arm circumference - third assessment(12 months post natally)
- Screen time / sleep time questionnaire - first assessment(3 months old)
- Mother's fat mss and lean mass (body composition) determined using Bioelectrical Impedance Analysis (BIA) - third assessment(12 months post natally)
- Mother's fat mass and lean mass (body composition) determined using deuterium (2H) dilution technique - first assessment(30-32 weeks gestation)
- Mother's fat mass and lean mass (body composition) determined using skin fold measurements - first assessment(30-32 weeks gestation)
- Screen time / sleep time questionnaire - second assessment(6 months old)
- Mother's fat mass and lean mass (body composition) determined using Bioelectrical Impedance Analysis (BIA) - first assessment(30-32 weeks gestation)
- Mother's fat mass and lean mass (body composition) using deuterium dilution - second assessment(3 months post natally)