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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04047888
Enrollment
152
Registered
2019-08-07
Start date
2019-01-28
Completion date
2021-12-31
Last updated
2019-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Obesity

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

OTHERNutrition-based education on infant feeding and practices as well as Non nutrition-based educational message

60 minute educational message at each visit

OTHERNon nutrition-based educational message

No nutrition-based education on infant feeding and practices

Sponsors

International Atomic Energy Agency
CollaboratorOTHER_GOV
The University of The West Indies
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

MeasureTime frameDescription
Child's fat mass and lean mass (body composition) determined using the Air Displacement Plethysmography - third assessment6 months oldMeasurement 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 assessment6 months oldChild'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 assessment6 months oldChild's fat mass and lean mass (body composition) determined using a Bioelectrical Impedance Analyzer
Child's mid-upper arm circumference - first assessment6 monthsChild'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 assessment12 months oldChild'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 assessment12 months oldChild's fat mass and lean mass (body composition) determined using a Bioelectrical Impedance Analyzer
Child's mid-upper arm circumference - second assessment12 months oldChild'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 assessment6 months oldMeasurement 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 assessment12 months oldMeasurement of fat mass and lean mass (body composition) using the deuterium dilution method
Child's weight in kilograms - first assessment4 weeks oldChild's weight measured using a digital scale
Child's weight in kilograms - second assessment3 months oldChild's weight measured using a digital scale
Child's weight in kilograms - third assessment6 months oldChild's weight measured using a digital scale
Child's weight in kilograms - fourth assessment12 months oldChild's weight measured using a digital scale
Child's length in centimeters - first assessment4 weeks oldChild's length measured using a stadiometer
Child's length in centimeters - second assessment3 months oldChild's length measured using a stadiometer
Child's length in centimeters - third assessment6 months oldChild's length measured using a stadiometer
Child's length in centimeters - fourth assessment12 months oldChild'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 oldA 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 assessment4 weeks oldMeasurement 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 assessment3 months oldMeasurement of child's fat mass and lean mass (body composition) using the Air Displacement Plethysmography
Feeding Questionnaire - first assessment2 weeks oldThis 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 assessment4 weeks oldThis 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 assessment3 months oldThis 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 assessment6 months oldThis 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 assessment12 months oldThis 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

MeasureTime frameDescription
Screen time / sleep time questionnaire - second assessment6 months oldThis 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 assessment12 months oldThis 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 child3 months oldTo 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 assessment30-32 weeks gestationFat 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 assessment30-32 weeks gestationFat 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 assessment30-32 weeks gestationFat mass and lean mass (body composition) measured using BIA analyzer
Mother's weight - first assessment30-32 weeks gestationMother's weight measured using a digital scale
Mother's height30-32 weeks gestationMother's height measured using a stadiometer
Mother's mid-upper arm circumference - first assessment30-32 weeks gestationMother'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 assessment3 months post natallyMother'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 assessment3 months post natallyFat mass and lean mass (body composition) determined measured using BIA analyzer
Mother's fat mass and lean mass (body composition) using deuterium dilution - second assessment3 months post natallyFat mass and lean mass (body composition) determined using deuterium dilution during breastmilk assessment
mother's weight - second assessment3 months post natallymothers weight measured using a scale
mother's mid-upper arm circumference - second assessment3 months post natallymother'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 assessment12 months post natallyMother'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 assessment12 months post natallymother's fat mass and lean mass (body composition) determined using BIA analyzer
mother's weight - third assessment12 months post natallymothers weight measured using a scale
mother's mid-upper arm circumference - third assessment12 months post natallymother's mid-upper arm circumference measured using a tape measure
Screen time / sleep time questionnaire - first assessment3 months oldThis 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

Contacts

Primary ContactCarolyn R Taylor Bryan, PhD
carolyn.taylorbryan@uwimona.edu.jm876.553.7882
Backup ContactAsha V Badaloo, PhD
asha.badaloo@uwimona.edu.jm876.927.1884

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026