Childhood Obesity
Conditions
Brief summary
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
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.
Interventions
60 minute educational message at each visit
No nutrition-based education on infant feeding and practices
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child's fat mass and lean mass (body composition) determined using the Air Displacement Plethysmography - third assessment | 6 months old | Measurement of child's fat mass and lean mass (body composition) using the Air Displacement Plethysmography |
| Child's lean mass and fat mass (body composition) determined using skin fold measurements - first assessment | 6 months old | Child's fat mass and lean mass (body composition) determined using skin fold callipers |
| Child's fat mass and lean mass (body composition) determined using Bioelectrical Impedance Analysis (BIA) - first assessment | 6 months old | Child's fat mass and lean mass (body composition) determined using a Bioelectrical Impedance Analyzer |
| Child's mid-upper arm circumference - first assessment | 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 | 12 months old | Child's fat mass and lean mass (body composition) determined using skin fold callipers |
| Child's fat mass and lean mass (body composition) determined using Bioelectrical Impedance Analysis (BIA) - second assessment | 12 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 | 12 months old | Child's mid-upper arm circumference measured using a tape measure |
| Child's fat mass and lean mass (body composition) determined using deuterium dilution method - first assessment | 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 | 12 months old | Measurement of fat mass and lean mass (body composition) using the deuterium dilution method |
| Child's weight in kilograms - first assessment | 4 weeks old | Child's weight measured using a digital scale |
| Child's weight in kilograms - second assessment | 3 months old | Child's weight measured using a digital scale |
| Child's weight in kilograms - third assessment | 6 months old | Child's weight measured using a digital scale |
| Child's weight in kilograms - fourth assessment | 12 months old | Child's weight measured using a digital scale |
| Child's length in centimeters - first assessment | 4 weeks old | Child's length measured using a stadiometer |
| Child's length in centimeters - second assessment | 3 months old | Child's length measured using a stadiometer |
| Child's length in centimeters - third assessment | 6 months old | Child's length measured using a stadiometer |
| Child's length in centimeters - fourth assessment | 12 months 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) | 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 Air Displacement Plethysmography - first assessment | 4 weeks old | Measurement of child's fat mass and lean mass (body composition) using the Air Displacement Plethysmography |
| Child's fat mass and lean mass (body composition) determined using the Air Displacement Plethysmography - second assessment | 3 months old | Measurement of child's fat mass and lean mass (body composition) using the Air Displacement Plethysmography |
| Feeding Questionnaire - first assessment | 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 - second assessment | 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. |
| Feeding Questionnaire - third assessment | 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 - fourth assessment | 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. |
| Feeding Questionnaire - fifth assessment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Screen time / sleep time questionnaire - second assessment | 6 months old | 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. |
| Screen time / sleep time questionnaire - third assessment | 12 months old | 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. |
| Breastmilk intake in child | 3 months old | 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. |
| Mother's fat mass and lean mass (body composition) determined using deuterium (2H) dilution technique - first assessment | 30-32 weeks gestation | Fat mass and lean mass (body composition)determined using deuterium (2H) dilution technique |
| Mother's fat mass and lean mass (body composition) determined using skin fold measurements - first assessment | 30-32 weeks gestation | Fat mass and lean mass (body composition) measured using skin fold callipers |
| Mother's fat mass and lean mass (body composition) determined using Bioelectrical Impedance Analysis (BIA) - first assessment | 30-32 weeks gestation | Fat mass and lean mass (body composition) measured using BIA analyzer |
| Mother's weight - first assessment | 30-32 weeks gestation | Mother's weight measured using a digital scale |
| Mother's height | 30-32 weeks gestation | Mother's height measured using a stadiometer |
| Mother's mid-upper arm circumference - first assessment | 30-32 weeks gestation | Mother's mid-upper arm circumference measured using a tape measure |
| 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 calliper |
| Mother's fat mass and lean mass (body composition) determined using Bioelectrical Impedance Analysis (BIA) - second assessment | 3 months post natally | Fat mass and lean mass (body composition) determined measured using BIA analyzer |
| Mother's fat mass and lean mass (body composition) using deuterium dilution - second assessment | 3 months post natally | Fat mass and lean mass (body composition) determined using deuterium dilution during breastmilk assessment |
| mother's weight - second assessment | 3 months post natally | mothers weight measured using a scale |
| mother's mid-upper arm circumference - second assessment | 3 months post natally | mother's mid-upper arm circumference measured using a tape measure |
| Mother's fat mass and lean mass (body composition) determined using skin fold measurements - third assessment | 12 months post natally | Mother's fat mass and lean mass (body composition) determined using skin fold callipers |
| 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 BIA analyzer |
| mother's weight - third assessment | 12 months post natally | mothers weight measured using a scale |
| mother's mid-upper arm circumference - third assessment | 12 months post natally | mother's mid-upper arm circumference measured using a tape measure |
| Screen time / sleep time questionnaire - first assessment | 3 months old | 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. |
Countries
Jamaica