An interventional study of Didactic dietary sessions and Education Tool in Obesity, Gestational Weight Gain and Obesity, Maternal, sponsored by The University of The West Indies. Status unknown. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-10.
Sponsored by The University of The West Indies · Not applicable, Interventional, and Health services research
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.
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.
36 studies on the registry are indexed under Obesity, Maternal; 7 are open to participants now.
This study's planned enrollment of 172 is above the median of 100 across 21 interventional studies indexed under Obesity, Maternal.
Browse Obesity, Maternal studies →The University of The West Indies is the lead sponsor of 62 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
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 · Behavioral: Education Tool
Women will receive a standard patient education tool in the form of a leaflet.
Behavioral: Education Tool
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.
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.
Mean change in gestational weight in kilograms in each arm of the trial
Weight at or before delivery minus weight at enrolment
Time frame: From enrolment until delivery
Mean neonatal birth weight in grams in each arm of the trial
Weight of the neonate at birth
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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
Time frame: After one minute of birth
Rates of the various modes of delivery
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
Rates of Augmentation or Induction of labour
Augmentation of labour. Induction of labour
Time frame: At the time of delivery
Rates of preterm birth
Birth before 37 completed weeks of pregnancy
Time frame: From enrolment until delivery
Rates of admission to Neonatal Intensive Care Unit
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
Rates of the presence of foetal malformation
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
Rates of foetal death
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
No study locations are listed for this record.
Plan to share: No
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The University of The West Indies