Diet Versus Control Pregnant Barbadian Women Gestational Weight Gain Trial

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity, Gestational Weight Gain, Obesity, Maternal

Intervention / Treatment
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* Behavioral: Didactic dietary sessions
* Behavioral: Education Tool


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Didactic Sessions<br>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<br>* 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.<br>Behavioral: Education Tool<br>* 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.<br>|
| Experimental: Education Tool<br>Women will receive a standard patient education tool in the form of a leaflet. | Behavioral: Education Tool<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in gestational weight in kilograms in each arm of the trial | 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 | Weight of the neonate at birth | Within one hour of birth | 
| Incidence of pregnancy induced hypertension in each arm of the trial | 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 | 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 | 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 | Defined as a score less than seven | After one minute of birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Barbados, Barbadian, Obesity, Gestational Weight Gain, Pregnancy, Afro-Caribbean