Assessment of Risk Factors for Childhood Obesity and Nutrition Education Intervention on Infant Growth and Development
- Conditions
- Childhood Obesity
- Interventions
- Other: Nutrition-based education on infant feeding and practices as well as Non nutrition-based educational messageOther: Non nutrition-based educational message
- Registration Number
- NCT04047888
- Lead Sponsor
- The University of The West Indies
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 152
- Women (18-40 years)
- Women 30 -32 weeks gestation
- First or second pregnancy
- Healthy term infants ( > 37 completed weeks)
- Infants with birthweight >2.5kg)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Intervention Group Nutrition-based education on infant feeding and practices as well as Non nutrition-based educational message 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 Control Group Non nutrition-based educational message 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.
- Primary Outcome Measures
Name Time Method 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
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.
Child's weight in kilograms - first assessment 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 4 weeks 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 - 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 - 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.
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 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 weight in kilograms - second assessment 3 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 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 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 - 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.
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 - second assessment 12 months old Child's mid-upper arm circumference measured using a tape measure
Child's weight in kilograms - third assessment 6 months old Child's weight measured using a digital scale
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 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 - fourth assessment 12 months old Child's weight measured using a digital scale
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
- Secondary Outcome Measures
Name Time Method 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 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 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 weight - third assessment 12 months post natally mothers weight measured using a scale
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 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 Bioelectrical Impedance Analysis (BIA) - second assessment 3 months post natally Fat mass and lean mass (body composition) determined measured using BIA analyzer
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 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.
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 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
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.
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 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
Trial Locations
- Locations (1)
Tropical Metabolism Research Unit, TMRU University of the West Indies,
🇯🇲Mona, Jamaica