Childhood ObesityNCT04047888
Assessment of Risk Factors for Childhood Obesity and Nutrition Education Intervention on Infant Growth and Development
An observational study of Childhood Obesity, run by The University of The West Indies at 1 site in Jamaica.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Nutrition-based education on infant feeding and practices as well as Non nutrition-based educational message and Non nutrition-based educational message
- How many people
- 152 participants
- Where
- 1 siteJamaica
- Study dates
- 28 Jan 2019to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- Women (18-40 years)
- Women 30 -32 weeks gestation
- First or second pregnancy
- Healthy term infants ( > 37 completed weeks)
- Infants with birthweight >2.5kg)
Who cannot join
- Pre-gestational diabetes
- Pre-gestational hypertension
- Sickle cell disease
- HIV infection,
- Psychiatric disorder
- Gestational diabetes
Show all 9Show fewer
- Infants with congenital abnormalities
- Infants with chromosomal disorders
- Infants admitted in neonatal period > 48 hours
Trial locations and contacts
1 site in 1 country.
Jamaica1 site, 1 recruiting
- Recruiting
Tropical Metabolism Research Unit, TMRU University of the West Indies,
Mona
Carolyn R TaylorBryan, PhD, 876.927.1884, carolyn.taylorbryan@uwimona.edu.jm
Asha V Badaloo, PhD, 876.927.1884, asha.badaloo@uwimona.edu.jm
About this study
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
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.
Read the 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.
- Conditions
- Childhood Obesity
- Being tested
- Nutrition-based education on infant feeding and practices as well as Non nutrition-based educational message, Non nutrition-based educational message
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition-based education on infant feeding and practices as well as Non nutrition-based educational messageOther
60 minute educational message at each visit
Non nutrition-based educational messageOther
No nutrition-based education on infant feeding and practices
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Nutrition-based education on infant feeding and practices as well as 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. Receives: Other: Non nutrition-based educational message |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 6 months old
Child's mid-upper arm circumference - first assessment
Child's mid-upper arm circumference measured using a tape measure
Measured: 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
Measured: 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
Measured: 12 months old
Child's mid-upper arm circumference - second assessment
Child's mid-upper arm circumference measured using a tape measure
Measured: 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
Measured: 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
Measured: 12 months old
Child's weight in kilograms - first assessment
Child's weight measured using a digital scale
Measured: 4 weeks old
Child's weight in kilograms - second assessment
Child's weight measured using a digital scale
Measured: 3 months old
Child's weight in kilograms - third assessment
Child's weight measured using a digital scale
Measured: 6 months old
Child's weight in kilograms - fourth assessment
Child's weight measured using a digital scale
Measured: 12 months old
Child's length in centimeters - first assessment
Child's length measured using a stadiometer
Measured: 4 weeks old
Child's length in centimeters - second assessment
Child's length measured using a stadiometer
Measured: 3 months old
Child's length in centimeters - third assessment
Child's length measured using a stadiometer
Measured: 6 months old
Child's length in centimeters - fourth assessment
Child's length measured using a stadiometer
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months old
Secondary outcomes (19)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 30-32 weeks gestation
Mother's weight - first assessment
Mother's weight measured using a digital scale
Measured: 30-32 weeks gestation
Mother's height
Mother's height measured using a stadiometer
Measured: 30-32 weeks gestation
Mother's mid-upper arm circumference - first assessment
Mother's mid-upper arm circumference measured using a tape measure
Measured: 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
Measured: 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
Measured: 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
Measured: 3 months post natally
mother's weight - second assessment
mothers weight measured using a scale
Measured: 3 months post natally
mother's mid-upper arm circumference - second assessment
mother's mid-upper arm circumference measured using a tape measure
Measured: 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
Measured: 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
Measured: 12 months post natally
mother's weight - third assessment
mothers weight measured using a scale
Measured: 12 months post natally
mother's mid-upper arm circumference - third assessment
mother's mid-upper arm circumference measured using a tape measure
Measured: 12 months post natally
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start28 Jan 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of The West Indies
- Sponsor type
- University, hospital or other
- Collaborators
- International Atomic Energy Agency
- Responsible party
- Sponsor
- Investigators
- Carolyn R Taylor Bryan, PhD, Principal investigator, University of the West Indies, Mona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04047888
- Sponsor's protocol ID
- EC115-17/18
- Status last verified
- Feb 2019
- First submitted
- 15 Jun 2019
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04047888
- Acronym / sponsor ID
- EC115-17/18
- Conditions
- Childhood Obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- The University of The West IndiesUniversity, hospital or other
- Collaborators
- International Atomic Energy Agency
- Study start
- 28 Jan 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 7 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | – | Other: Nutrition-based education on infant feeding and practices as well as Non nutrition-based educational messageMothers 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 | – | Other: Non nutrition-based educational messageMothers 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (5 listed)
- Women (18-40 years)
- Women 30 -32 weeks gestation
- First or second pregnancy
- Healthy term infants ( > 37 completed weeks)
- Infants with birthweight >2.5kg)
Key exclusion criteria (9 listed)
- Pre-gestational diabetes
- Pre-gestational hypertension
- Sickle cell disease
- HIV infection,
- Psychiatric disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition-based education on infant feeding and practices as well as Non nutrition-based educational message60 minute educational message at each visit | Other | Intervention Group |
| Non nutrition-based educational messageNo nutrition-based education on infant feeding and practices | Other | Control Group |
Primary outcome
Feeding Questionnaire - first assessment
Time frame: 2 weeks old
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.
Feeding Questionnaire - second assessment
Time frame: 4 weeks old
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.
Feeding Questionnaire - third assessment
Time frame: 3 months old
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.
Feeding Questionnaire - fourth assessment
Time frame: 6 months old
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.
Feeding Questionnaire - fifth assessment
Time frame: 12 months old
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.
Child's lean mass and fat mass (body composition) determined using skin fold measurements - first assessment
Time frame: 6 months old
Child's fat mass and lean mass (body composition) determined using skin fold callipers
Child's fat mass and lean mass (body composition) determined using Bioelectrical Impedance Analysis (BIA) - first assessment
Time frame: 6 months old
Child's fat mass and lean mass (body composition) determined using a Bioelectrical Impedance Analyzer
Child's mid-upper arm circumference - first assessment
Time frame: 6 months
Child's mid-upper arm circumference measured using a tape measure
Child's lean mass and fat mass (body composition) determined using skin fold measurements - second assessment
Time frame: 12 months old
Child's fat mass and lean mass (body composition) determined using skin fold callipers
Child's fat mass and lean mass (body composition) determined using Bioelectrical Impedance Analysis (BIA) - second assessment
Time frame: 12 months old
Child's fat mass and lean mass (body composition) determined using a Bioelectrical Impedance Analyzer
Child's mid-upper arm circumference - second assessment
Time frame: 12 months old
Child's mid-upper arm circumference measured using a tape measure
Child's fat mass and lean mass (body composition) determined using deuterium dilution method - first assessment
Time frame: 6 months old
Measurement of fat mass and lean mass (body composition) using the deuterium dilution method
Child's fat mass and lean mass (body composition) determined using deuterium dilution method - second assessment
Time frame: 12 months old
Measurement of fat mass and lean mass (body composition) using the deuterium dilution method
Child's weight in kilograms - first assessment
Time frame: 4 weeks old
Child's weight measured using a digital scale
Child's weight in kilograms - second assessment
Time frame: 3 months old
Child's weight measured using a digital scale
Child's weight in kilograms - third assessment
Time frame: 6 months old
Child's weight measured using a digital scale
Child's weight in kilograms - fourth assessment
Time frame: 12 months old
Child's weight measured using a digital scale
Child's length in centimeters - first assessment
Time frame: 4 weeks old
Child's length measured using a stadiometer
Child's length in centimeters - second assessment
Time frame: 3 months old
Child's length measured using a stadiometer
Child's length in centimeters - third assessment
Time frame: 6 months old
Child's length measured using a stadiometer
Child's length in centimeters - fourth assessment
Time frame: 12 months old
Child's length measured using a stadiometer
Child's fat mass and lean mass (body composition) determined using Dual-energy X-ray absorptiometry (DEXA)
Time frame: 12 months old
A whole body DEXA scan will be done as described by the International Atomic Energy Agency. A scan takes about 7 minutes.
Child's fat mass and lean mass (body composition) determined using Air Displacement Plethysmography - first assessment
Time frame: 4 weeks old
Measurement of child's fat mass and lean mass (body composition) using the Air Displacement Plethysmography
Child's fat mass and lean mass (body composition) determined using the Air Displacement Plethysmography - second assessment
Time frame: 3 months old
Measurement of child's fat mass and lean mass (body composition) using the Air Displacement Plethysmography
Child's fat mass and lean mass (body composition) determined using the Air Displacement Plethysmography - third assessment
Time frame: 6 months old
Measurement of child's fat mass and lean mass (body composition) using the Air Displacement Plethysmography
19 secondary outcomes
Screen time / sleep time questionnaire - first assessment
Time frame: 3 months old
Screen time / sleep time questionnaire - second assessment
Time frame: 6 months old
Screen time / sleep time questionnaire - third assessment
Time frame: 12 months old
Breastmilk intake in child
Time frame: 3 months old
Mother's fat mass and lean mass (body composition) determined using deuterium (2H) dilution technique - first assessment
Time frame: 30-32 weeks gestation
Mother's fat mass and lean mass (body composition) determined using skin fold measurements - first assessment
Time frame: 30-32 weeks gestation
Mother's fat mass and lean mass (body composition) determined using Bioelectrical Impedance Analysis (BIA) - first assessment
Time frame: 30-32 weeks gestation
Mother's weight - first assessment
Time frame: 30-32 weeks gestation
Mother's height
Time frame: 30-32 weeks gestation
Mother's mid-upper arm circumference - first assessment
Time frame: 30-32 weeks gestation
Mother's fat mass and lean mass (body composition) determined using skin fold measurements - second assessment
Time frame: 3 months post natally
Mother's fat mass and lean mass (body composition) determined using Bioelectrical Impedance Analysis (BIA) - second assessment
Time frame: 3 months post natally
Mother's fat mass and lean mass (body composition) using deuterium dilution - second assessment
Time frame: 3 months post natally
mother's weight - second assessment
Time frame: 3 months post natally
mother's mid-upper arm circumference - second assessment
Time frame: 3 months post natally
Mother's fat mass and lean mass (body composition) determined using skin fold measurements - third assessment
Time frame: 12 months post natally
Mother's fat mss and lean mass (body composition) determined using Bioelectrical Impedance Analysis (BIA) - third assessment
Time frame: 12 months post natally
mother's weight - third assessment
Time frame: 12 months post natally
mother's mid-upper arm circumference - third assessment
Time frame: 12 months post natally
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolyn R Taylor Bryan, PhD principal investigator
University of the West Indies, Mona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Obesity, run by The University of The West Indies at 1 site in Jamaica.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jamaica. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carolyn R Taylor Bryan, PhD (876.553.7882, carolyn.taylorbryan@uwimona.edu.jm), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feeding Questionnaire - first assessment (time frame: 2 weeks old). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019.