An observational study in Childhood Obesity, sponsored by The University of The West Indies. Status unknown at 1 site in Jamaica. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-07.
Sponsored by The University of The West Indies · Observational
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.
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.
1,129 studies on the registry are indexed under Pediatric Obesity; 187 are open to participants now.
This study's planned enrollment of 152 is below the median of 180 across 235 observational studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →The University of The West Indies is the lead sponsor of 64 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The target populations from which participants will be selected will consist of pregnant women attending antenatal visits at Public Health Centers in Kingston and St. Andrew (KSA). Mothers will be recruited prior to 30-32 weeks gestation and study measurements will be made in the middle of the third trimesters
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
60 minute educational message at each visit
No nutrition-based education on infant feeding and practices
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 6 months old
Child's mid-upper arm circumference - first assessment
Child's mid-upper arm circumference measured using a tape measure
Time frame: 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
Time frame: 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
Time frame: 12 months old
Child's mid-upper arm circumference - second assessment
Child's mid-upper arm circumference measured using a tape measure
Time frame: 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
Time frame: 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
Time frame: 12 months old
Child's weight in kilograms - first assessment
Child's weight measured using a digital scale
Time frame: 4 weeks old
Child's weight in kilograms - second assessment
Child's weight measured using a digital scale
Time frame: 3 months old
Child's weight in kilograms - third assessment
Child's weight measured using a digital scale
Time frame: 6 months old
Child's weight in kilograms - fourth assessment
Child's weight measured using a digital scale
Time frame: 12 months old
Child's length in centimeters - first assessment
Child's length measured using a stadiometer
Time frame: 4 weeks old
Child's length in centimeters - second assessment
Child's length measured using a stadiometer
Time frame: 3 months old
Child's length in centimeters - third assessment
Child's length measured using a stadiometer
Time frame: 6 months old
Child's length in centimeters - fourth assessment
Child's length measured using a stadiometer
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 months old
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 30-32 weeks gestation
Mother's weight - first assessment
Mother's weight measured using a digital scale
Time frame: 30-32 weeks gestation
Mother's height
Mother's height measured using a stadiometer
Time frame: 30-32 weeks gestation
Mother's mid-upper arm circumference - first assessment
Mother's mid-upper arm circumference measured using a tape measure
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 3 months post natally
mother's weight - second assessment
mothers weight measured using a scale
Time frame: 3 months post natally
mother's mid-upper arm circumference - second assessment
mother's mid-upper arm circumference measured using a tape measure
Time frame: 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
Time frame: 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
Time frame: 12 months post natally
mother's weight - third assessment
mothers weight measured using a scale
Time frame: 12 months post natally
mother's mid-upper arm circumference - third assessment
mother's mid-upper arm circumference measured using a tape measure
Time frame: 12 months post natally
Plan to share: Undecided
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This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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The University of The West Indies