Clinical trial NCT05575414: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Gestational Weight Gain
Obesity, Maternal
Keywords: Obesity
Gestational Weight Gain
Pregnancy
Afro-Caribbean
Barbadian
Barbados
Lead sponsor: The University of The West Indies
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 172
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Mean change in gestational weight in kilograms in each arm of the trial
timeFrame: From enrolment until delivery
Secondary outcomes:
measure: Mean neonatal birth weight in grams in each arm of the trial
timeFrame: Within one hour of birth
measure: Incidence of pregnancy induced hypertension in each arm of the trial
timeFrame: Beyond 20 weeks gestation and prior to delivery
measure: Incidence of gestational diabetes in each arm of the trial
timeFrame: Beyond 20 weeks gestation and prior to delivery
measure: Incidence of primary post partum haemorrhage in each arm of the trial
timeFrame: Within 24 hours of delivery
measure: Incidence of low one minute APGAR score in each arm of the trial
timeFrame: After one minute of birth
Other outcomes:
measure: Rates of the various modes of delivery
timeFrame: At time of delivery
measure: Rates of Augmentation or Induction of labour
timeFrame: At the time of delivery
measure: Rates of preterm birth
timeFrame: From enrolment until delivery
measure: Rates of admission to Neonatal Intensive Care Unit
timeFrame: From birth to one week of life
measure: Rates of the presence of foetal malformation
timeFrame: From enrolment until delivery
measure: Rates of foetal death
timeFrame: From enrolment until delivery
Locations:
Study officials:
affiliation: University of the West Indies Cave hill Campus
name: Damian AJ Best, DM MRCOG MSc
role: STUDY_DIRECTOR
References:
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