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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Education Tool | Experimental | Women will receive a standard patient education tool in the form of a leaflet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean neonatal birth weight in grams in each arm of the trial | Weight of the neonate at birth | Within one hour of birth |
| Incidence of pregnancy induced hypertension in each arm of the trial | New hypertension presenting after 20 weeks of pregnancy without significant proteinuria |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Rates of Augmentation or Induction of labour |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tonya C Johnson, MBBS | Contact | 4366450 | obesityinpregnancystudy@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Damian AJ Best, DM MRCOG MSc | University of the West Indies Cave hill Campus | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18824817 | Background | 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. | |
| 17416786 | 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. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D000078064 | Gestational Weight Gain |
| D000079262 | Pregnancy in Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| 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. |
|
| Beyond 20 weeks gestation and prior to delivery |
| 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 |
| 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 |
| 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 |
Augmentation of labour. Induction of labour
| At the time of delivery |
| Rates of preterm birth | Birth before 37 completed weeks of pregnancy | From enrolment until delivery |
| 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 |
| 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 |
| 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 |
| 23613888 | 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. |
| 26016557 | 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. |
| 24737366 | 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. |
| 18227847 | 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. |
| 21972411 | 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. |
| 33582580 | 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. |
| 33609271 | 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. |
| 26165396 | 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. |
| 20669500 | 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/ |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015430 | Weight Gain |
| D001836 | Body Weight Changes |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |