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Diet Versus Control Pregnant Barbadian Women Gestational Weight Gain Trial

Primary Purpose

Obesity, Gestational Weight Gain, Obesity, Maternal

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Didactic dietary sessions
Education Tool
Sponsored by
The University of The West Indies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Obesity focused on measuring Obesity, Gestational Weight Gain, Pregnancy, Afro-Caribbean, Barbadian, Barbados

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Didactic Sessions

    Education Tool

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Mean change in gestational weight in kilograms in each arm of the trial
    Weight at or before delivery minus weight at enrolment

    Secondary Outcome Measures

    Mean neonatal birth weight in grams in each arm of the trial
    Weight of the neonate at birth
    Incidence of pregnancy induced hypertension in each arm of the trial
    New hypertension presenting after 20 weeks of pregnancy without significant proteinuria
    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
    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).
    Incidence of low one minute APGAR score in each arm of the trial
    Defined as a score less than seven

    Full Information

    First Posted
    October 5, 2022
    Last Updated
    December 30, 2022
    Sponsor
    The University of The West Indies
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05575414
    Brief Title
    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

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2023 (Anticipated)
    Primary Completion Date
    February 2023 (Anticipated)
    Study Completion Date
    June 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The University of The West Indies

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Gestational Weight Gain, Obesity, Maternal
    Keywords
    Obesity, Gestational Weight Gain, Pregnancy, Afro-Caribbean, Barbadian, Barbados

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    172 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Didactic Sessions
    Arm Type
    Experimental
    Arm Description
    Women will receive online nutrition education by a registered dietitian, in addition to the same standard patient education tool as the other arm.
    Arm Title
    Education Tool
    Arm Type
    Experimental
    Arm Description
    Women will receive a standard patient education tool in the form of a leaflet.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Didactic dietary sessions
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Education Tool
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Mean change in gestational weight in kilograms in each arm of the trial
    Description
    Weight at or before delivery minus weight at enrolment
    Time Frame
    From enrolment until delivery
    Secondary Outcome Measure Information:
    Title
    Mean neonatal birth weight in grams in each arm of the trial
    Description
    Weight of the neonate at birth
    Time Frame
    Within one hour of birth
    Title
    Incidence of pregnancy induced hypertension in each arm of the trial
    Description
    New hypertension presenting after 20 weeks of pregnancy without significant proteinuria
    Time Frame
    Beyond 20 weeks gestation and prior to delivery
    Title
    Incidence of gestational diabetes in each arm of the trial
    Description
    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
    Title
    Incidence of primary post partum haemorrhage in each arm of the trial
    Description
    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
    Title
    Incidence of low one minute APGAR score in each arm of the trial
    Description
    Defined as a score less than seven
    Time Frame
    After one minute of birth
    Other Pre-specified Outcome Measures:
    Title
    Rates of the various modes of delivery
    Description
    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
    Title
    Rates of Augmentation or Induction of labour
    Description
    Augmentation of labour. Induction of labour
    Time Frame
    At the time of delivery
    Title
    Rates of preterm birth
    Description
    Birth before 37 completed weeks of pregnancy
    Time Frame
    From enrolment until delivery
    Title
    Rates of admission to Neonatal Intensive Care Unit
    Description
    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
    Title
    Rates of the presence of foetal malformation
    Description
    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
    Title
    Rates of foetal death
    Description
    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

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tonya C Johnson, MBBS
    Phone
    4366450
    Email
    obesityinpregnancystudy@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Damian AJ Best, DM MRCOG MSc
    Organizational Affiliation
    University of the West Indies Cave hill Campus
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
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    18824817
    Citation
    Satpathy HK, Fleming A, Frey D, Barsoom M, Satpathy C, Khandalavala J. Maternal obesity and pregnancy. Postgrad Med. 2008 Sep 15;120(3):E01-9. doi: 10.3810/pgm.2008.09.1920.
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    Citation
    Chu SY, Callaghan WM, Kim SY, Schmid CH, Lau J, England LJ, Dietz PM. Maternal obesity and risk of gestational diabetes mellitus. Diabetes Care. 2007 Aug;30(8):2070-6. doi: 10.2337/dc06-2559a. Epub 2007 Apr 6.
    Results Reference
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    PubMed Identifier
    23613888
    Citation
    Yu Z, Han S, Zhu J, Sun X, Ji C, Guo X. Pre-pregnancy body mass index in relation to infant birth weight and offspring overweight/obesity: a systematic review and meta-analysis. PLoS One. 2013 Apr 16;8(4):e61627. doi: 10.1371/journal.pone.0061627. Print 2013.
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    PubMed Identifier
    26016557
    Citation
    Marchi J, Berg M, Dencker A, Olander EK, Begley C. Risks associated with obesity in pregnancy, for the mother and baby: a systematic review of reviews. Obes Rev. 2015 Aug;16(8):621-38. doi: 10.1111/obr.12288. Epub 2015 May 28.
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    Aune D, Saugstad OD, Henriksen T, Tonstad S. Maternal body mass index and the risk of fetal death, stillbirth, and infant death: a systematic review and meta-analysis. JAMA. 2014 Apr 16;311(15):1536-46. doi: 10.1001/jama.2014.2269.
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    PubMed Identifier
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    Citation
    Wolff S, Legarth J, Vangsgaard K, Toubro S, Astrup A. A randomized trial of the effects of dietary counseling on gestational weight gain and glucose metabolism in obese pregnant women. Int J Obes (Lond). 2008 Mar;32(3):495-501. doi: 10.1038/sj.ijo.0803710. Epub 2008 Jan 29.
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    PubMed Identifier
    21972411
    Citation
    Vinter CA, Jensen DM, Ovesen P, Beck-Nielsen H, Jorgensen JS. The LiP (Lifestyle in Pregnancy) study: a randomized controlled trial of lifestyle intervention in 360 obese pregnant women. Diabetes Care. 2011 Dec;34(12):2502-7. doi: 10.2337/dc11-1150. Epub 2011 Oct 4.
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    Citation
    Lima Ferreira J, Voss G, Doria M, Sa Couto A, Principe RM. Benefit of insufficient gestational weight gain in obese women with gestational diabetes mellitus: A multicenter study in Portugal. Diabetes Metab Syndr. 2021 Jan-Feb;15(1):419-424. doi: 10.1016/j.dsx.2021.01.020. Epub 2021 Feb 8.
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