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

NCT ID: NCT04047888

Last Updated: 2019-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

152 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-28

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Childhood Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

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

Intervention Type OTHER

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.

Non nutrition-based educational message

Intervention Type OTHER

No nutrition-based education on infant feeding and practices

Interventions

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

60 minute educational message at each visit

Intervention Type OTHER

Non nutrition-based educational message

No nutrition-based education on infant feeding and practices

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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International Atomic Energy Agency

OTHER_GOV

Sponsor Role collaborator

The University of The West Indies

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carolyn R Taylor Bryan, PhD

Role: PRINCIPAL_INVESTIGATOR

University of the West Indies, Mona

Locations

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Tropical Metabolism Research Unit, TMRU University of the West Indies,

Mona, , Jamaica

Site Status RECRUITING

Countries

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Jamaica

Central Contacts

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Carolyn R Taylor Bryan, PhD

Role: CONTACT

876.553.7882

Asha V Badaloo, PhD

Role: CONTACT

876.927.1884

Facility Contacts

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Carolyn R TaylorBryan, PhD

Role: primary

876.927.1884

Asha V Badaloo, PhD

Role: backup

876.927.1884

Other Identifiers

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EC115-17/18

Identifier Type: -

Identifier Source: org_study_id

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