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

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.

Study Overview

• Status: Unknown
• Conditions: Childhood Obesity
• Intervention / Treatment: Other: Nutrition-based education on infant feeding and practices as well as Non nutrition-based educational message; Other: Non nutrition-based educational message

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.

• Study Type: Observational
• Enrollment (Anticipated): 152

Contacts and Locations

• Study Contact: Name: Carolyn R Taylor Bryan, PhD; Phone Number: 876.553.7882; Email: carolyn.taylorbryan@uwimona.edu.jm
• Study Contact Backup: Name: Asha V Badaloo, PhD; Phone Number: 876.927.1884; Email: asha.badaloo@uwimona.edu.jm

Study Locations

• Jamaica
  • Mona, Jamaica
    • Recruiting
    • Tropical Metabolism Research Unit, TMRU University of the West Indies,
    • Contact: Asha V Badaloo, PhD; Phone Number: 876.927.1884; Email: asha.badaloo@uwimona.edu.jm
    • Contact: Carolyn R TaylorBryan, PhD; Phone Number: 876.927.1884; Email: carolyn.taylorbryan@uwimona.edu.jm
    • Sub-Investigator: Sherine D Whyte, MSc
    • Sub-Investigator: Novie d YoungerColeman, PhD
    • Sub-Investigator: Sharmaine E Edwards, M.Sc
    • Sub-Investigator: Orgen L Brown, PHN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intervention Group; 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; 60 minute educational message at each visit
Control Group; 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; No nutrition-based education on infant feeding and practices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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	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	6 months old
Child's mid-upper arm circumference - first assessment	Child's mid-upper arm circumference measured using a tape measure	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	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	12 months old
Child's mid-upper arm circumference - second assessment	Child's mid-upper arm circumference measured using a tape measure	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	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	12 months old
Child's weight in kilograms - first assessment	Child's weight measured using a digital scale	4 weeks old
Child's weight in kilograms - second assessment	Child's weight measured using a digital scale	3 months old
Child's weight in kilograms - third assessment	Child's weight measured using a digital scale	6 months old
Child's weight in kilograms - fourth assessment	Child's weight measured using a digital scale	12 months old
Child's length in centimeters - first assessment	Child's length measured using a stadiometer	4 weeks old
Child's length in centimeters - second assessment	Child's length measured using a stadiometer	3 months old
Child's length in centimeters - third assessment	Child's length measured using a stadiometer	6 months old
Child's length in centimeters - fourth assessment	Child's length measured using a stadiometer	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.	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	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	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	6 months old

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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	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	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	30-32 weeks gestation
Mother's weight - first assessment	Mother's weight measured using a digital scale	30-32 weeks gestation
Mother's height	Mother's height measured using a stadiometer	30-32 weeks gestation
Mother's mid-upper arm circumference - first assessment	Mother's mid-upper arm circumference measured using a tape measure	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	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	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	3 months post natally
mother's weight - second assessment	mothers weight measured using a scale	3 months post natally
mother's mid-upper arm circumference - second assessment	mother's mid-upper arm circumference measured using a tape measure	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	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	12 months post natally
mother's weight - third assessment	mothers weight measured using a scale	12 months post natally
mother's mid-upper arm circumference - third assessment	mother's mid-upper arm circumference measured using a tape measure	12 months post natally

Collaborators and Investigators

• Sponsor: The University of The West Indies
• Collaborators: International Atomic Energy Agency
• Investigators: Principal Investigator: Carolyn R Taylor Bryan, PhD, University of the West Indies, mona

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 28, 2019
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: June 15, 2019
• First Submitted That Met QC Criteria: August 5, 2019
• First Posted (ACTUAL): August 7, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 7, 2019
• Last Update Submitted That Met QC Criteria: August 5, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: EC115-17/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No