Clinical trial NCT04047888: Assessment of Risk Factors for Childhood Obesity and Nutrition Education Intervention on Infant Growth and Development
Official title: Assessment of Risk Factors for Childhood Obesity and the Impact of a Nutrition-based Educational Intervention on Infant Feeding, Growth and Body Composition
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Childhood Obesity
Lead sponsor: The University of The West Indies
Sponsor class: OTHER
Collaborators: name: International Atomic Energy Agency
First posted: 2019-08-07
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feeding Questionnaire - first assessment
timeFrame: 2 weeks old
measure: Feeding Questionnaire - second assessment
timeFrame: 4 weeks old
measure: Feeding Questionnaire - third assessment
timeFrame: 3 months old
measure: Feeding Questionnaire - fourth assessment
timeFrame: 6 months old
measure: Feeding Questionnaire - fifth assessment
timeFrame: 12 months old
measure: Child's lean mass and fat mass (body composition) determined using skin fold measurements - first assessment
timeFrame: 6 months old
measure: Child's fat mass and lean mass (body composition) determined using Bioelectrical Impedance Analysis (BIA) - first assessment
timeFrame: 6 months old
measure: Child's mid-upper arm circumference - first assessment
timeFrame: 6 months
measure: Child's lean mass and fat mass (body composition) determined using skin fold measurements - second assessment
timeFrame: 12 months old
measure: Child's fat mass and lean mass (body composition) determined using Bioelectrical Impedance Analysis (BIA) - second assessment
timeFrame: 12 months old
measure: Child's mid-upper arm circumference - second assessment
timeFrame: 12 months old
measure: Child's fat mass and lean mass (body composition) determined using deuterium dilution method - first assessment
timeFrame: 6 months old
measure: Child's fat mass and lean mass (body composition) determined using deuterium dilution method - second assessment
timeFrame: 12 months old
measure: Child's weight in kilograms - first assessment
timeFrame: 4 weeks old
measure: Child's weight in kilograms - second assessment
timeFrame: 3 months old
measure: Child's weight in kilograms - third assessment
timeFrame: 6 months old
measure: Child's weight in kilograms - fourth assessment
timeFrame: 12 months old
measure: Child's length in centimeters - first assessment
timeFrame: 4 weeks old
measure: Child's length in centimeters - second assessment
timeFrame: 3 months old
measure: Child's length in centimeters - third assessment
timeFrame: 6 months old
measure: Child's length in centimeters - fourth assessment
timeFrame: 12 months old
measure: Child's fat mass and lean mass (body composition) determined using Dual-energy X-ray absorptiometry (DEXA)
timeFrame: 12 months old
measure: Child's fat mass and lean mass (body composition) determined using Air Displacement Plethysmography - first assessment
timeFrame: 4 weeks old
measure: Child's fat mass and lean mass (body composition) determined using the Air Displacement Plethysmography - second assessment
timeFrame: 3 months old
measure: Child's fat mass and lean mass (body composition) determined using the Air Displacement Plethysmography - third assessment
timeFrame: 6 months old
Secondary outcomes:
measure: Screen time / sleep time questionnaire - first assessment
timeFrame: 3 months old
measure: Screen time / sleep time questionnaire - second assessment
timeFrame: 6 months old
measure: Screen time / sleep time questionnaire - third assessment
timeFrame: 12 months old
measure: Breastmilk intake in child
timeFrame: 3 months old
measure: Mother's fat mass and lean mass (body composition) determined using deuterium (2H) dilution technique - first assessment
timeFrame: 30-32 weeks gestation
measure: Mother's fat mass and lean mass (body composition) determined using skin fold measurements - first assessment
timeFrame: 30-32 weeks gestation
measure: Mother's fat mass and lean mass (body composition) determined using Bioelectrical Impedance Analysis (BIA) - first assessment
timeFrame: 30-32 weeks gestation
measure: Mother's weight - first assessment
timeFrame: 30-32 weeks gestation
measure: Mother's height
timeFrame: 30-32 weeks gestation
measure: Mother's mid-upper arm circumference - first assessment
timeFrame: 30-32 weeks gestation
measure: Mother's fat mass and lean mass (body composition) determined using skin fold measurements - second assessment
timeFrame: 3 months post natally
measure: Mother's fat mass and lean mass (body composition) determined using Bioelectrical Impedance Analysis (BIA) - second assessment
timeFrame: 3 months post natally
measure: Mother's fat mass and lean mass (body composition) using deuterium dilution - second assessment
timeFrame: 3 months post natally
measure: mother's weight - second assessment
timeFrame: 3 months post natally
measure: mother's mid-upper arm circumference - second assessment
timeFrame: 3 months post natally
measure: Mother's fat mass and lean mass (body composition) determined using skin fold measurements - third assessment
timeFrame: 12 months post natally
measure: Mother's fat mss and lean mass (body composition) determined using Bioelectrical Impedance Analysis (BIA) - third assessment
timeFrame: 12 months post natally
measure: mother's weight - third assessment
timeFrame: 12 months post natally
measure: mother's mid-upper arm circumference - third assessment
timeFrame: 12 months post natally
Other outcomes:
Locations:
city: Mona
country: Jamaica
facility: Tropical Metabolism Research Unit, TMRU University of the West Indies,
Study officials:
affiliation: University of the West Indies, Mona
name: Carolyn R Taylor Bryan, PhD
role: PRINCIPAL_INVESTIGATOR
References: