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

Childhood Obesity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04047888
• Other study ID #: EC115-17/18
• Status: Recruiting
• Start date: January 28, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2019
• Source: The University of The West Indies
• Contact: Carolyn R Taylor Bryan, PhD
• Phone: 876.553.7882
• Email: carolyn.taylorbryan[@]uwimona.edu.jm
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 152
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Pediatric Obesity

Intervention

Other:
• Nutrition-based education on infant feeding and practices as well as Non nutrition-based educational message
60 minute educational message at each visit
• Non nutrition-based educational message
No nutrition-based education on infant feeding and practices

Locations

Country	Name	City	State
Jamaica	Tropical Metabolism Research Unit, TMRU University of the West Indies,	Mona

Sponsors (2)

Lead Sponsor	Collaborator
The University of The West Indies	International Atomic Energy Agency

Country where clinical trial is conducted

Jamaica, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Child's mid-upper arm circumference - first assessment	Child's mid-upper arm circumference measured using a tape measure	6 months
Primary	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
Primary	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
Primary	Child's mid-upper arm circumference - second assessment	Child's mid-upper arm circumference measured using a tape measure	12 months old
Primary	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
Primary	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
Primary	Child's weight in kilograms - first assessment	Child's weight measured using a digital scale	4 weeks old
Primary	Child's weight in kilograms - second assessment	Child's weight measured using a digital scale	3 months old
Primary	Child's weight in kilograms - third assessment	Child's weight measured using a digital scale	6 months old
Primary	Child's weight in kilograms - fourth assessment	Child's weight measured using a digital scale	12 months old
Primary	Child's length in centimeters - first assessment	Child's length measured using a stadiometer	4 weeks old
Primary	Child's length in centimeters - second assessment	Child's length measured using a stadiometer	3 months old
Primary	Child's length in centimeters - third assessment	Child's length measured using a stadiometer	6 months old
Primary	Child's length in centimeters - fourth assessment	Child's length measured using a stadiometer	12 months old
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Mother's weight - first assessment	Mother's weight measured using a digital scale	30-32 weeks gestation
Secondary	Mother's height	Mother's height measured using a stadiometer	30-32 weeks gestation
Secondary	Mother's mid-upper arm circumference - first assessment	Mother's mid-upper arm circumference measured using a tape measure	30-32 weeks gestation
Secondary	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
Secondary	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
Secondary	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
Secondary	mother's weight - second assessment	mothers weight measured using a scale	3 months post natally
Secondary	mother's mid-upper arm circumference - second assessment	mother's mid-upper arm circumference measured using a tape measure	3 months post natally
Secondary	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
Secondary	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
Secondary	mother's weight - third assessment	mothers weight measured using a scale	12 months post natally
Secondary	mother's mid-upper arm circumference - third assessment	mother's mid-upper arm circumference measured using a tape measure	12 months post natally