Diet Versus Control Pregnant Barbadian Women Gestational Weight Gain Trial

December 30, 2022 updated by: Tonya Johnson, The University of The West Indies

Outcomes of Pregnant Barbadian Women With Obesity: A Case Controlled Prospective Study of Didactic Dietary Intervention Compared to a Standard Education Tool

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

172

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Didactic Sessions
Women will receive online nutrition education by a registered dietitian, in addition to the same standard patient education tool as the other arm.
Behavioral: Didactic dietary sessions
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.
Behavioral: Education Tool
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.
Experimental: Education Tool
Women will receive a standard patient education tool in the form of a leaflet.
Behavioral: Education Tool
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in gestational weight in kilograms in each arm of the trial
Time Frame: From enrolment until delivery
Weight at or before delivery minus weight at enrolment
From enrolment until delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean neonatal birth weight in grams in each arm of the trial
Time Frame: Within one hour of birth
Weight of the neonate at birth
Within one hour of birth
Incidence of pregnancy induced hypertension in each arm of the trial
Time Frame: Beyond 20 weeks gestation and prior to delivery
New hypertension presenting after 20 weeks of pregnancy without significant proteinuria
Beyond 20 weeks gestation and prior to delivery
Incidence of gestational diabetes in each arm of the trial
Time Frame: Beyond 20 weeks gestation and prior to delivery
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
Beyond 20 weeks gestation and prior to delivery
Incidence of primary post partum haemorrhage in each arm of the trial
Time Frame: Within 24 hours of delivery
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).
Within 24 hours of delivery
Incidence of low one minute APGAR score in each arm of the trial
Time Frame: After one minute of birth
Defined as a score less than seven
After one minute of birth

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of the various modes of delivery
Time Frame: At time of delivery
A qualitative variable described as vaginal delivery, assisted vaginal delivery or caesarean section and obtained from the patient's labour record
At time of delivery
Rates of Augmentation or Induction of labour
Time Frame: At the time of delivery
Augmentation of labour. Induction of labour
At the time of delivery
Rates of preterm birth
Time Frame: From enrolment until delivery
Birth before 37 completed weeks of pregnancy
From enrolment until delivery
Rates of admission to Neonatal Intensive Care Unit
Time Frame: From birth to one week of life
A qualitative variable described as admitted or not admitted to the neonatal intensive care unit and obtained from the participant's infant medical record
From birth to one week of life
Rates of the presence of foetal malformation
Time Frame: From enrolment until delivery
A qualitative variable described as malformation present or not present and obtained form the participant's infant medical record
From enrolment until delivery
Rates of foetal death
Time Frame: From enrolment until delivery
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.
From enrolment until delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of The West Indies

Investigators

  • Study Director: Damian AJ Best, DM MRCOG MSc, University of the West Indies Cave hill Campus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

October 5, 2022

First Submitted That Met QC Criteria

October 5, 2022

First Posted (Actual)

October 12, 2022

Study Record Updates

Last Update Posted (Estimate)

January 10, 2023

Last Update Submitted That Met QC Criteria

December 30, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gestational Weight Gain Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe