Diet Versus Control Pregnant Barbadian Women Gestational Weight Gain Trial

NCT05575414 | Unknown

• 1 other identifier: Gestational Weight Gain Study
• Study Type: interventional
• Target: 172
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity; Gestational Weight Gain; Obesity, Maternal

Keywords

Obesity; Gestational Weight Gain; Pregnancy; Afro-Caribbean; Barbadian; Barbados

Outcome Measures

Primary Outcomes (1)

• Mean change in gestational weight in kilograms in each arm of the trial

  Weight at or before delivery minus weight at enrolment

  From enrolment until delivery

Secondary Outcomes (5)

• Mean neonatal birth weight in grams in each arm of the trial

  Within one hour of birth

• Incidence of pregnancy induced hypertension in each arm of the trial

  Beyond 20 weeks gestation and prior to delivery

• Incidence of gestational diabetes in each arm of the trial

  Beyond 20 weeks gestation and prior to delivery

• Incidence of primary post partum haemorrhage in each arm of the trial

  Within 24 hours of delivery

• Incidence of low one minute APGAR score in each arm of the trial

  After one minute of birth

Other Outcomes (6)

• Rates of the various modes of delivery

  At time of delivery

• Rates of Augmentation or Induction of labour

  At the time of delivery

• Rates of preterm birth

  From enrolment until delivery

Study Arms (2)

Didactic Sessions

EXPERIMENTAL

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

Education Tool

EXPERIMENTAL

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

Behavioral: Education Tool

Interventions

Didactic dietary sessions BEHAVIORAL

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.

Didactic Sessions

Education Tool BEHAVIORAL

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.

Didactic Sessions; Education Tool

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Presence of gestational diabetes or chronic diabetes mellitus,
• Have had bariatric surgery
• Do not speak english
• Pregnancy with a multiple gestation.

Sponsors & Collaborators

• The University of The West Indies: lead

Related Publications (11)

• 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.

  PMID: 18824817 BACKGROUND

• 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.

  PMID: 17416786 BACKGROUND

• 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.

  PMID: 23613888 BACKGROUND

• 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.

  PMID: 26016557 BACKGROUND

• 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.

  PMID: 24737366 BACKGROUND

• 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.

  PMID: 18227847 BACKGROUND

• 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.

  PMID: 21972411 BACKGROUND

• 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.

  PMID: 33582580 BACKGROUND

• Olander EK, Hill B, Skouteris H. Healthcare Professional Training Regarding Gestational Weight Gain: Recommendations and Future Directions. Curr Obes Rep. 2021 Jun;10(2):116-124. doi: 10.1007/s13679-021-00429-x. Epub 2021 Feb 20.

  PMID: 33609271 BACKGROUND

• Poston L, Bell R, Croker H, Flynn AC, Godfrey KM, Goff L, Hayes L, Khazaezadeh N, Nelson SM, Oteng-Ntim E, Pasupathy D, Patel N, Robson SC, Sandall J, Sanders TA, Sattar N, Seed PT, Wardle J, Whitworth MK, Briley AL; UPBEAT Trial Consortium. Effect of a behavioural intervention in obese pregnant women (the UPBEAT study): a multicentre, randomised controlled trial. Lancet Diabetes Endocrinol. 2015 Oct;3(10):767-77. doi: 10.1016/S2213-8587(15)00227-2. Epub 2015 Jul 9.

  PMID: 26165396 BACKGROUND

• Institute of Medicine (US) and National Research Council (US) Committee to Reexamine IOM Pregnancy Weight Guidelines; Rasmussen KM, Yaktine AL, editors. Weight Gain During Pregnancy: Reexamining the Guidelines. Washington (DC): National Academies Press (US); 2009. Available from http://www.ncbi.nlm.nih.gov/books/NBK32813/

  PMID: 20669500 BACKGROUND

MeSH Terms

Conditions

Obesity; Gestational Weight Gain; Pregnancy in Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Weight Gain; Body Weight Changes; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Damian AJ Best, DM MRCOG MSc

  University of the West Indies Cave hill Campus

  STUDY DIRECTOR

Central Study Contacts

Tonya C Johnson, MBBS

CONTACT

4366450; obesityinpregnancystudy@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 12, 2022
• Study Start: January 1, 2023
• Primary Completion: February 1, 2023
• Study Completion: June 1, 2023
• Last Updated: January 10, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share