Gestational Weight Gain, Obesity, Obesity, Maternal
Conditions
Keywords
Obesity, Gestational Weight Gain, Pregnancy, Afro-Caribbean, Barbadian, Barbados
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.
Interventions
BEHAVIORALDidactic 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.
BEHAVIORALEducation 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.
Sponsors
The University of The West Indies
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in gestational weight in kilograms in each arm of the trial | From enrolment until delivery | Weight at or before delivery minus weight at enrolment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean neonatal birth weight in grams in each arm of the trial | Within one hour of birth | Weight of the neonate at birth |
| Incidence of pregnancy induced hypertension in each arm of the trial | Beyond 20 weeks gestation and prior to delivery | New hypertension presenting after 20 weeks of pregnancy without significant proteinuria |
| Incidence of gestational diabetes in each arm of the trial | 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 |
| Incidence of primary post partum haemorrhage in each arm of the trial | 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). |
| Incidence of low one minute APGAR score in each arm of the trial | After one minute of birth | Defined as a score less than seven |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rates of the various modes of delivery | 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 |
| Rates of Augmentation or Induction of labour | At the time of delivery | Augmentation of labour. Induction of labour |
| Rates of preterm birth | From enrolment until delivery | Birth before 37 completed weeks of pregnancy |
| Rates of admission to Neonatal Intensive Care Unit | 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 |
| Rates of the presence of foetal malformation | From enrolment until delivery | A qualitative variable described as malformation present or not present and obtained form the participant's infant medical record |
| Rates of foetal death | 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. |
Contacts
Primary ContactTonya C Johnson, MBBS
Outcome results
None listed