Assessment of Risk Factors for Childhood Obesity and Nutrition Education Intervention on Infant Growth and Development
1 other identifier
observational
152
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 28, 2019
CompletedFirst Submitted
Initial submission to the registry
June 15, 2019
CompletedFirst Posted
Study publicly available on registry
August 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedAugust 7, 2019
February 1, 2019
2.9 years
June 15, 2019
August 5, 2019
Conditions
Outcome Measures
Primary Outcomes (25)
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 Outcomes (19)
Screen time / sleep time questionnaire - first assessment
3 months old
Screen time / sleep time questionnaire - second assessment
6 months old
Screen time / sleep time questionnaire - third assessment
12 months old
Breastmilk intake in child
3 months old
Mother's fat mass and lean mass (body composition) determined using deuterium (2H) dilution technique - first assessment
30-32 weeks gestation
- +14 more secondary outcomes
Study Arms (2)
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
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.
Interventions
60 minute educational message at each visit
No nutrition-based education on infant feeding and practices
Eligibility Criteria
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
You may qualify if:
- Women (18-40 years)
- Women 30 -32 weeks gestation
- First or second pregnancy
- Healthy term infants ( \> 37 completed weeks)
- Infants with birthweight \>2.5kg)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tropical Metabolism Research Unit, TMRU University of the West Indies,
Mona, Jamaica
Biospecimen
The first sample will be the baseline sample. After that a dose of deuterium oxide will be administered and then two other samples of saliva will be taken at 3 hours and four hour intervals. when the dose has equilibrated with total body water. Saliva samples will be collected using a dry cotton wool swab. With assistance, the swab will be moved around the mouth until the cotton wool is sodden. After removing the plunger from a 20 ml syringe barrel, the cotton wool from the swab will be removed and placed in the barrel of the syringe the plunger will be replaced and used to squeeze the saliva into a cryovial for storage at - 20 degrees centigrade for later analysis of deuterium enrichment by FTIR.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carolyn R Taylor Bryan, PhD
University of the West Indies, Mona
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2019
First Posted
August 7, 2019
Study Start
January 28, 2019
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
August 7, 2019
Record last verified: 2019-02