Diet Versus Control Pregnant Barbadian Women Gestational Weight Gain Trial
Primary Purpose
Obesity, Gestational Weight Gain, Obesity, Maternal
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Didactic dietary sessions
Education Tool
Sponsored by
About this trial
This is an interventional health services research trial for Obesity focused on measuring Obesity, Gestational Weight Gain, Pregnancy, Afro-Caribbean, Barbadian, Barbados
Eligibility Criteria
Inclusion Criteria:
- Woman over 18 years old
- Live singleton pregnancy
- BMI of greater than or equal to 35kg/m^2
- Registered patient of the Queen Elizabeth Hospital Antenatal Clinic
Exclusion Criteria:
- Presence of gestational diabetes or chronic diabetes mellitus,
- Have had bariatric surgery
- Do not speak english
- Pregnancy with a multiple gestation.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Didactic Sessions
Education Tool
Arm Description
Women will receive online nutrition education by a registered dietitian, in addition to the same standard patient education tool as the other arm.
Women will receive a standard patient education tool in the form of a leaflet.
Outcomes
Primary Outcome Measures
Mean change in gestational weight in kilograms in each arm of the trial
Weight at or before delivery minus weight at enrolment
Secondary Outcome Measures
Mean neonatal birth weight in grams in each arm of the trial
Weight of the neonate at birth
Incidence of pregnancy induced hypertension in each arm of the trial
New hypertension presenting after 20 weeks of pregnancy without significant proteinuria
Incidence of gestational diabetes in each arm of the trial
Defined using the National Diabetes Data Group (NDDG) criteria, which uses fasting, 1-hour, 2-hour, and 3-hour plasma glucose levels of 5.8mmol/L, 10.6mmol/L, 9.2mmol/L and 8.1mmol/L respectively diagnosed after 20 weeks gestation
Incidence of primary post partum haemorrhage in each arm of the trial
The loss of 500 milliliters or more of blood from the genital tract within 24 hours of the birth of a baby. Postpartum haemorrhage will be further subclassified as minor (blood loss 500-1000 ml) or major (blood loss more than 1000 ml)27. Major postpartum haemorrhage will also be subdivided into moderate (1001-2000 ml) and severe (more than 2000 ml).
Incidence of low one minute APGAR score in each arm of the trial
Defined as a score less than seven
Full Information
NCT ID
NCT05575414
First Posted
October 5, 2022
Last Updated
December 30, 2022
Sponsor
The University of The West Indies
1. Study Identification
Unique Protocol Identification Number
NCT05575414
Brief Title
Diet Versus Control Pregnant Barbadian Women Gestational Weight Gain Trial
Official Title
Outcomes of Pregnant Barbadian Women With Obesity: A Case Controlled Prospective Study of Didactic Dietary Intervention Compared to a Standard Education Tool
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2023 (Anticipated)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of The West Indies
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The researcher will study a group of pregnant Barbadians with BMI at booking of greater than or equal to 35. All of the women will be given leaflets telling them about healthy diets in pregnancy and how to limit weight gain. Half of the women will be sent to the dietitian for small group classes on diet and how to limit weight gain. The two groups of women will be compared to see which group gains more weight and which group has more complications during the pregnancy.
Detailed Description
More than 2100 pregnant women per annum deliver their babies at the Queen Elizabeth Hospital, the lone publicly-funded hospital providing secondary and tertiary-level obstetric care in Barbados. Routinely recorded data do not capture whether patients are overweight or obese. Thus, the prevalence of obesity is not known amongst this population. Additionally, these women are not routinely referred for dietician services, and thus the impact of dietician intervention is not known. The aim of this research is to determine whether a dietitian-led intervention could lead to decreased gestational weight gain and less incidence of foetal macrosomia in a sample of Barbadian women, with class II obesity, attending a public antenatal clinic. Prior studies examining gestational weight gain, found no statistically significance between groups when a BMI of 30 was used. It is hoped that by using a group with higher obesity a larger difference will be seen with the intervention. Participants with body mass index greater than 35kg/m^2 who meet the eligibility criteria will be selected from one of five antenatal clinics at the Queen Elizabeth Hospital on the island of Barbados. They will be randomised to either receive didactic dietary sessions or a standard education tool. Mean weight change will be compared amongst the two groups after delivery to determine if there was a decrease in gestational weight gain amongst the intervention group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Gestational Weight Gain, Obesity, Maternal
Keywords
Obesity, Gestational Weight Gain, Pregnancy, Afro-Caribbean, Barbadian, Barbados
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
172 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Didactic Sessions
Arm Type
Experimental
Arm Description
Women will receive online nutrition education by a registered dietitian, in addition to the same standard patient education tool as the other arm.
Arm Title
Education Tool
Arm Type
Experimental
Arm Description
Women will receive a standard patient education tool in the form of a leaflet.
Intervention Type
Behavioral
Intervention Name(s)
Didactic dietary sessions
Intervention Description
Three one-hour online nutrition group classes will be scheduled at 17, 21 and 29 weeks gestation (± 1 week). Nutrient dense foods and beverages and limiting the intake of added sugars, sodium and saturated fat will be encouraged, as well as reading the nutrition facts label, individual goal setting and self-monitoring. Physician recommended physical activity will be encouraged. Food and beverage intake data will be measured by 24-hour dietary recalls collected on three non-consecutive days. Data will be collected by telephone interview by a registered dietitian or dietary technician on four separate occasions: 16, 20 and 28 weeks gestation (± 1 week) and 36 weeks of gestation. Details on portions consumed will be estimated using standard measuring cups and household utensils. Nutrient intake will be generated using Vision Software Nutrient Analysis Software and the United States Department of Agriculture Food Composition Database, Food Data Central.
Intervention Type
Behavioral
Intervention Name(s)
Education Tool
Intervention Description
The standard patient education tool will take the form of a leaflet which will include 1. A definition of body mass index 2. A list of measures to be taken to limit weight gain in pregnancy. 3. A description of the major nutrients required in pregnancy (folate, iron, calcium, vitamin D and protein). and 4.A description of the six food groups with recommendations for the number of servings per day.
Primary Outcome Measure Information:
Title
Mean change in gestational weight in kilograms in each arm of the trial
Description
Weight at or before delivery minus weight at enrolment
Time Frame
From enrolment until delivery
Secondary Outcome Measure Information:
Title
Mean neonatal birth weight in grams in each arm of the trial
Description
Weight of the neonate at birth
Time Frame
Within one hour of birth
Title
Incidence of pregnancy induced hypertension in each arm of the trial
Description
New hypertension presenting after 20 weeks of pregnancy without significant proteinuria
Time Frame
Beyond 20 weeks gestation and prior to delivery
Title
Incidence of gestational diabetes in each arm of the trial
Description
Defined using the National Diabetes Data Group (NDDG) criteria, which uses fasting, 1-hour, 2-hour, and 3-hour plasma glucose levels of 5.8mmol/L, 10.6mmol/L, 9.2mmol/L and 8.1mmol/L respectively diagnosed after 20 weeks gestation
Time Frame
Beyond 20 weeks gestation and prior to delivery
Title
Incidence of primary post partum haemorrhage in each arm of the trial
Description
The loss of 500 milliliters or more of blood from the genital tract within 24 hours of the birth of a baby. Postpartum haemorrhage will be further subclassified as minor (blood loss 500-1000 ml) or major (blood loss more than 1000 ml)27. Major postpartum haemorrhage will also be subdivided into moderate (1001-2000 ml) and severe (more than 2000 ml).
Time Frame
Within 24 hours of delivery
Title
Incidence of low one minute APGAR score in each arm of the trial
Description
Defined as a score less than seven
Time Frame
After one minute of birth
Other Pre-specified Outcome Measures:
Title
Rates of the various modes of delivery
Description
A qualitative variable described as vaginal delivery, assisted vaginal delivery or caesarean section and obtained from the patient's labour record
Time Frame
At time of delivery
Title
Rates of Augmentation or Induction of labour
Description
Augmentation of labour. Induction of labour
Time Frame
At the time of delivery
Title
Rates of preterm birth
Description
Birth before 37 completed weeks of pregnancy
Time Frame
From enrolment until delivery
Title
Rates of admission to Neonatal Intensive Care Unit
Description
A qualitative variable described as admitted or not admitted to the neonatal intensive care unit and obtained from the participant's infant medical record
Time Frame
From birth to one week of life
Title
Rates of the presence of foetal malformation
Description
A qualitative variable described as malformation present or not present and obtained form the participant's infant medical record
Time Frame
From enrolment until delivery
Title
Rates of foetal death
Description
A qualitative variable described as foetus dead or alive and obtained from the medical record of the participant or the medical record of the participant's infant.
Time Frame
From enrolment until delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Woman over 18 years old
Live singleton pregnancy
BMI of greater than or equal to 35kg/m^2
Registered patient of the Queen Elizabeth Hospital Antenatal Clinic
Exclusion Criteria:
Presence of gestational diabetes or chronic diabetes mellitus,
Have had bariatric surgery
Do not speak english
Pregnancy with a multiple gestation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tonya C Johnson, MBBS
Phone
4366450
Email
obesityinpregnancystudy@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Damian AJ Best, DM MRCOG MSc
Organizational Affiliation
University of the West Indies Cave hill Campus
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
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Diet Versus Control Pregnant Barbadian Women Gestational Weight Gain Trial
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