Diet Versus Control Pregnant Barbadian Women Gestational Weight Gain Trial

The University of The West Indies

Status: Not yet enrolling

Conditions: Obesity, Maternal; Obesity; Gestational Weight Gain

Treatments: Behavioral: Education Tool; Behavioral: Didactic dietary sessions

Study type: Interventional

Funder types: Other

Identifiers

NCT05575414

Gestational Weight Gain Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 172 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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172 participants in 2 patient groups

Didactic Sessions

Experimental group

Description:

Women will receive online nutrition education by a registered dietitian, in addition to the same standard patient education tool as the other arm.

Treatment:

Behavioral: Didactic dietary sessions

Behavioral: Education Tool

Education Tool

Experimental group

Description:

Women will receive a standard patient education tool in the form of a leaflet.

Treatment:

Behavioral: Education Tool