Diet Versus Control Pregnant Barbadian Women Gestational Weight Gain Trial

Obesity Clinical 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05575414
• Other study ID #: Gestational Weight Gain Study
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2023
• Est. completion date: June 2023

Study information

• Verified date: December 2022
• Source: The University of The West Indies
• Contact: Tonya C Johnson, MBBS
• Phone: 4366450
• Email: obesityinpregnancystudy[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 172
• Est. completion date: June 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gestational Weight Gain
• Obesity
• Weight Gain

Intervention

Behavioral:
• Didactic dietary sessions
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.
• Education Tool
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The University of The West Indies

References & Publications (11)

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. — View 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. — View Citation

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/ — View 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. — View 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. — View Citation

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. — View Citation

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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	At time of delivery
Other	Rates of Augmentation or Induction of labour	Augmentation of labour. Induction of labour	At the time of delivery
Other	Rates of preterm birth	Birth before 37 completed weeks of pregnancy	From enrolment until delivery
Other	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	From birth to one week of life
Other	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	From enrolment until delivery
Other	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.	From enrolment until delivery
Primary	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	Mean neonatal birth weight in grams in each arm of the trial	Weight of the neonate at birth	Within one hour of birth
Secondary	Incidence of pregnancy induced hypertension in each arm of the trial	New hypertension presenting after 20 weeks of pregnancy without significant proteinuria	Beyond 20 weeks gestation and prior to delivery
Secondary	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	Beyond 20 weeks gestation and prior to delivery
Secondary	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).	Within 24 hours of delivery
Secondary	Incidence of low one minute APGAR score in each arm of the trial	Defined as a score less than seven	After one minute of birth