Assessment of Risk Factors for Childhood Obesity and Nutrition Education Intervention on Infant Growth and Development

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Assessment of Risk Factors for Childhood Obesity and the Impact of a Nutrition-based Educational Intervention on Infant Feeding, Growth and Body Composition

Conditions
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Childhood Obesity

Intervention / Treatment
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* Other: Nutrition-based education on infant feeding and practices as well as Non nutrition-based educational message
* Other: Non nutrition-based educational message


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women (18-40 years) Women 30 -32 weeks gestation First or second pregnancy Healthy term infants ( > 37 completed weeks) Infants with birthweight >2.5kg) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention Group<br>Mothers and children in this group will have measurements, questionnaire administration. The children will have routine child care at their health center and mothers will have a 60 minute nutrition-based and non-nutrition based educational message | Other: Nutrition-based education on infant feeding and practices as well as Non nutrition-based educational message<br>* 60 minute educational message at each visit<br>|
| Control Group<br>Mothers and babies will have measurements and questionnaire administration and children will receive routine child care at their health centers. These mothers will receive a non-nutrition based educational message only. | Other: Non nutrition-based educational message<br>* No nutrition-based education on infant feeding and practices<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feeding Questionnaire - first assessment | 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. | 2 weeks old | 
| Feeding Questionnaire - second assessment | 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. | 4 weeks old | 
| Feeding Questionnaire - third assessment | 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. | 3 months old | 
| Feeding Questionnaire - fourth assessment | 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. | 6 months old | 
| Feeding Questionnaire - fifth assessment | 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. | 12 months old | 
| Child's lean mass and fat mass (body composition) determined using skin fold measurements - first assessment | Child's fat mass and lean mass (body composition) determined using skin fold callipers | 6 months old | 
| Child's fat mass and lean mass (body composition) determined using Bioelectrical Impedance Analysis (BIA) - first assessment | Child's fat mass and lean mass (body composition) determined using a Bioelectrical Impedance Analyzer | 6 months old | 
| Child's mid-upper arm circumference - first assessment | Child's mid-upper arm circumference measured using a tape measure | 6 months | 
| Child's lean mass and fat mass (body composition) determined using skin fold measurements - second assessment | Child's fat mass and lean mass (body composition) determined using skin fold callipers | 12 months old | 
| Child's fat mass and lean mass (body composition) determined using Bioelectrical Impedance Analysis (BIA) - second assessment | Child's fat mass and lean mass (body composition) determined using a Bioelectrical Impedance Analyzer | 12 months old | 
| Child's mid-upper arm circumference - second assessment | Child's mid-upper arm circumference measured using a tape measure | 12 months old | 
| Child's fat mass and lean mass (body composition) determined using deuterium dilution method - first assessment | Measurement of fat mass and lean mass (body composition) using the deuterium dilution method | 6 months old | 
| Child's fat mass and lean mass (body composition) determined using deuterium dilution method - second assessment | Measurement of fat mass and lean mass (body composition) using the deuterium dilution method | 12 months old | 
| Child's weight in kilograms - first assessment | Child's weight measured using a digital scale | 4 weeks old | 
| Child's weight in kilograms - second assessment | Child's weight measured using a digital scale | 3 months old | 
| Child's weight in kilograms - third assessment | Child's weight measured using a digital scale | 6 months old | 
| Child's weight in kilograms - fourth assessment | Child's weight measured using a digital scale | 12 months old | 
| Child's length in centimeters - first assessment | Child's length measured using a stadiometer | 4 weeks old | 
| Child's length in centimeters - second assessment | Child's length measured using a stadiometer | 3 months old | 
| Child's length in centimeters - third assessment | Child's length measured using a stadiometer | 6 months old | 
| Child's length in centimeters - fourth assessment | Child's length measured using a stadiometer | 12 months old | 
| Child's fat mass and lean mass (body composition) determined using Dual-energy X-ray absorptiometry (DEXA) | A whole body DEXA scan will be done as described by the International Atomic Energy Agency. A scan takes about 7 minutes. | 12 months old | 
| Child's fat mass and lean mass (body composition) determined using Air Displacement Plethysmography - first assessment | Measurement of child's fat mass and lean mass (body composition) using the Air Displacement Plethysmography | 4 weeks old | 
| Child's fat mass and lean mass (body composition) determined using the Air Displacement Plethysmography - second assessment | Measurement of child's fat mass and lean mass (body composition) using the Air Displacement Plethysmography | 3 months old | 
| Child's fat mass and lean mass (body composition) determined using the Air Displacement Plethysmography - third assessment | Measurement of child's fat mass and lean mass (body composition) using the Air Displacement Plethysmography | 6 months old | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Screen time / sleep time questionnaire - first assessment | This will describe total duration of sleep time and screen viewing time. Child's feeding pattern during the night will also be assessed (if the child fed or did not feed). Proportions will be used to compare responses between the intervention and control groups. Absolute values will also be compared for some questions. A scale will not be used. | 3 months old | 
| Screen time / sleep time questionnaire - second assessment | This will describe total duration of sleep time and screen viewing time. Child's feeding pattern during the night will also be assessed (if the child fed or did not feed). Proportions will be used to compare responses between the intervention and control groups. Absolute values will also be compared for some questions. A scale will not be used. | 6 months old | 
| Screen time / sleep time questionnaire - third assessment | This will describe total duration of sleep time and screen viewing time. Child's feeding pattern during the night will also be assessed (if the child fed or did not feed). Proportions will be used to compare responses between the intervention and control groups. Absolute values will also be compared for some questions. A scale will not be used. | 12 months old | 
| Breastmilk intake in child | To determine the amount of breastmilk consumed. The mother will consume a carefully weighed dose of deuterium. Saliva samples will be collected from the mother and her infant at baseline and at 2 timepoints between 1 and 14 days following dose consumption. Deuterium enrichment will be measured by Fourier transform infrared (FTIR) Spectrometry. | 3 months old | 
| Mother's fat mass and lean mass (body composition) determined using deuterium (2H) dilution technique - first assessment | Fat mass and lean mass (body composition)determined using deuterium (2H) dilution technique | 30-32 weeks gestation | 
| Mother's fat mass and lean mass (body composition) determined using skin fold measurements - first assessment | Fat mass and lean mass (body composition) measured using skin fold callipers | 30-32 weeks gestation | 
| Mother's fat mass and lean mass (body composition) determined using Bioelectrical Impedance Analysis (BIA) - first assessment | Fat mass and lean mass (body composition) measured using BIA analyzer | 30-32 weeks gestation | 
| Mother's weight - first assessment | Mother's weight measured using a digital scale | 30-32 weeks gestation | 
| Mother's height | Mother's height measured using a stadiometer | 30-32 weeks gestation | 
| Mother's mid-upper arm circumference - first assessment | Mother's mid-upper arm circumference measured using a tape measure | 30-32 weeks gestation | 
| Mother's fat mass and lean mass (body composition) determined using skin fold measurements - second assessment | Mother's fat mass and lean mass (body composition) determined using skin fold calliper | 3 months post natally | 
| Mother's fat mass and lean mass (body composition) determined using Bioelectrical Impedance Analysis (BIA) - second assessment | Fat mass and lean mass (body composition) determined measured using BIA analyzer | 3 months post natally | 
| Mother's fat mass and lean mass (body composition) using deuterium dilution - second assessment | Fat mass and lean mass (body composition) determined using deuterium dilution during breastmilk assessment | 3 months post natally | 
| mother's weight - second assessment | mothers weight measured using a scale | 3 months post natally | 
| mother's mid-upper arm circumference - second assessment | mother's mid-upper arm circumference measured using a tape measure | 3 months post natally | 
| Mother's fat mass and lean mass (body composition) determined using skin fold measurements - third assessment | Mother's fat mass and lean mass (body composition) determined using skin fold callipers | 12 months post natally | 
| Mother's fat mss and lean mass (body composition) determined using Bioelectrical Impedance Analysis (BIA) - third assessment | mother's fat mass and lean mass (body composition) determined using BIA analyzer | 12 months post natally | 
| mother's weight - third assessment | mothers weight measured using a scale | 12 months post natally | 
| mother's mid-upper arm circumference - third assessment | mother's mid-upper arm circumference measured using a tape measure | 12 months post natally |