Egg Intervention During Pregnancy in Indonesia

NCT04694235 | Active Not Recruiting DMC

• 1 other identifier: AASH Egg intervention
• Study Type: interventional
• Target: 702
• Locations: 1 country
• Sites: 1

Brief Summary

The study consists of two arms: 1) intervention group using eggs as supplementary food given from 2nd trimester of pregnancy to birth, and 2) observational group of pregnant mothers. it aims to assess the effectiveness of improving dietary quality during pregnancy on the epigenetic and stunting related outcomes (growth and development) in infants, who will be followed up until 24 months old

Conditions

Weight Gain; Anemia, Iron Deficiency; Birth Weight; Birth Length; Child Development; Zinc Deficiency; Folate Deficiency; B12 Deficiency Vitamin; Amino Acid Deficiency; Mineral Deficiency; Vitamin A Deficiency; Fatty Acid Deficiency; Parasite Infestation; E. Coli Infection; Salmonella Infections; Shigella Infection; Protozoan Infections

Keywords

Egg; Pregnancy; Indonesia; Epigenetic; Growth; Child development

Outcome Measures

Primary Outcomes (17)

• Prevalence of stunting

  Z-score of LAZ \<-2 SD based on WHO 2006

  birth until 24 months after delivery

• Proportion of children 10-14 months with impaired fine and gross motor skills

  Oxford Neurodevelopment Assessment (OX-NDA) is used to assess fine and gross motor skills among children aged 10 to 14 months

  10-14 months of age

• Proportion of children 10-14 months with impaired expressive and receptive language

  Oxford Neurodevelopment Assessment (OX-NDA) is used to assess expressive and receptive language among children aged 10 to 14 months

  10-14 months of age

• Proportion of children 10-14 months with impaired behavior

  Oxford Neurodevelopment Assessment (OX-NDA) is used to assess behavior among children aged 10 to 14 months

  10-14 months of age

• Proportion of children 10-14 months with impaired executive function

  Oxford Neurodevelopment Assessment (OX-NDA) is used to assess executive function among children aged 10 to 14 months

  10-14 months of age

• Proportion of children 10-14 months with impaired empathy

  Oxford Neurodevelopment Assessment (OX-NDA) is used to assess empathy among children aged 10 to 14 months

  10-14 months of age

• Proportion of children 10-14 months with impaired problem solving

  Oxford Neurodevelopment Assessment (OX-NDA) is used to assess problem solving among children aged 10 to 14 months

  10-14 months of age

• Proportion of children 10-14 months with impaired attention

  Oxford Neurodevelopment Assessment (OX-NDA) is used to assess attention among children aged 10 to 14 months

  10-14 months of age

• Proportion of children 10-14 months with impaired social-emotional reactivity

  Oxford Neurodevelopment Assessment (OX-NDA) is used to assess social-emotional reactivity among children aged 10 to 14 months

  10-14 months of age

• Proportion of children 20-24 months with impaired motor development

  INTERGROWTH Neurodevelopment Assessment (INTER-NDA) is used to assess motor development among children aged 20 to 24 months

  20-24 months of age

• Proportion of children 20-24 months with impaired cognition

  INTERGROWTH Neurodevelopment Assessment (INTER-NDA) is used to assess cognition among children aged 20 to 24 months

  20-24 months of age

• Proportion of children 20-24 months with impaired language

  INTERGROWTH Neurodevelopment Assessment (INTER-NDA) is used to assess language among children aged 20 to 24 months

  20-24 months of age

• Proportion of children 20-24 months with impaired social-emotional development

  INTERGROWTH Neurodevelopment Assessment (INTER-NDA) is used to assess social-emotional development among children aged 20 to 24 months

  20-24 months of age

• Scores of CDI vocabulary comprehension scale in children 10-12 months

  MacArthur-Bates Communicative Development Inventories (CDI) is used to assess vocabulary comprehension scale among children aged 10 to 12 months

  10-12 months of age

• Scores of CDI vocabulary production scale in children 10-12 months

  MacArthur-Bates Communicative Development Inventories (CDI) is used to assess vocabulary production among children aged 10 to 12 months

  10-12 months of age

• Epigenetic state of genes associated with stunting

  Genome-wide analysis of epigenetic states using the Illumina Infinium Methylation EPIC 850k Bead Chip (EPIC array) will be performed for selected samples from the core cohort. The outcomes will be the epigenetic state of a large number of genes which are associated with child stunting.

  parents: 72 h after delivery; baby: 72 h after delivery, 24 month

• Epigenetic markers of birth anthropometry, adult stature, metabolic state, and cognitive ability

  All samples (newborn, children 24 mo, parents) will be analyzed using Next Generation Bisulphite Amplicon Sequencing (BSAS) from Illumina MiSeq platform in targeted regions of the genome. The outcomes will be profiles of specific epigenetic markers of birth anthropometry, adult stature, metabolic state, and cognitive ability.

  parents: 72 h after delivery; baby: 72 h after delivery, 24 month

Secondary Outcomes (31)

• Weight gain during pregnancy

  2nd trimester (16-20 weeks gestation) and 3rd trimester (28-32 weeks gestation) of pregnancy

• Birth weight

  24 hours after birth

• Birth length

  24 hours after birth

• Hemoglobin concentration

  Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery

• Serum ferritin concentration

  Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery

Study Arms (2)

Observational cohort (control group)

NO INTERVENTION

In the observational cohort, pregnant mothers in the 2nd trimester (n=500) will be recruited and they will be followed up until their children are 24 months old. The control group women will receive standard intervention in the form of Ante Natal Care from village midwives (Polindes) or Puskesmas (IFA tablet, calcium tablet, nutrition counselling).

Intervention group

EXPERIMENTAL

The intervention group women (n=153) will be provided one egg three times per week from recruitment (2nd trimester) until term along with the standard Ante Natal Care.

Dietary Supplement: Egg intervention

Interventions

Egg intervention DIETARY_SUPPLEMENT

Eggs are boiled until the white and yolk are firm (ca. 8 minutes) to maintain quality and safety and ensure the eggs are safe for consumption.

Intervention group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Woman is between 16 and 20 weeks of pregnancy based on the date of the first day of her last menstrual period.
• She is 18-40 years of age.
• She is planning to remain in the study area over the next 30 months.
• She is of Sasak ethnicity

You may not qualify if:

• She is expecting multiple births.
• She has a known egg allergy.

Sponsors & Collaborators

• SEAMEO Regional Centre for Food and Nutrition: lead
• London School of Hygiene and Tropical Medicine: collaborator
• University of Aberdeen: collaborator
• University of Brighton: collaborator
• University College, London: collaborator
• Royal Veterinary College: collaborator
• Birkbeck, University of London: collaborator
• The International Livestock Research Institute (ILRI): collaborator
• Cheikh Anta Diop University, Senegal: collaborator
• National Institute of Nutrition, India: collaborator
• International Centre for Research in Agroforestry: collaborator
• Science Made Simple: collaborator
• Liverpool School of Tropical Medicine: collaborator
• International Initiative for Impact Evaluation: collaborator
• Digital Green Foundation: collaborator
• SOAS, University of London: collaborator
• University of Sheffield: collaborator

Study Sites (1)

Aikmel, Sakra, and Sikur Subdistrict

Mataram, West Nusa Tenggara, Indonesia

Location

Related Publications (19)

• Boeke CE, Gillman MW, Hughes MD, Rifas-Shiman SL, Villamor E, Oken E. Choline intake during pregnancy and child cognition at age 7 years. Am J Epidemiol. 2013 Jun 15;177(12):1338-47. doi: 10.1093/aje/kws395. Epub 2013 Feb 20.

  PMID: 23425631 BACKGROUND

• Caudill MA, Strupp BJ, Muscalu L, Nevins JEH, Canfield RL. Maternal choline supplementation during the third trimester of pregnancy improves infant information processing speed: a randomized, double-blind, controlled feeding study. FASEB J. 2018 Apr;32(4):2172-2180. doi: 10.1096/fj.201700692RR. Epub 2018 Jan 5.

  PMID: 29217669 BACKGROUND

• Clare CE, Brassington AH, Kwong WY, Sinclair KD. One-Carbon Metabolism: Linking Nutritional Biochemistry to Epigenetic Programming of Long-Term Development. Annu Rev Anim Biosci. 2019 Feb 15;7:263-287. doi: 10.1146/annurev-animal-020518-115206. Epub 2018 Nov 9.

  PMID: 30412672 BACKGROUND

• Haggarty P. Epigenetic consequences of a changing human diet. Proc Nutr Soc. 2013 Nov;72(4):363-71. doi: 10.1017/S0029665113003376. Epub 2013 Sep 13.

  PMID: 24028891 BACKGROUND

• Haggarty P, Hoad G, Campbell DM, Horgan GW, Piyathilake C, McNeill G. Folate in pregnancy and imprinted gene and repeat element methylation in the offspring. Am J Clin Nutr. 2013 Jan;97(1):94-9. doi: 10.3945/ajcn.112.042572. Epub 2012 Nov 14.

  PMID: 23151531 BACKGROUND

• Whitelaw N, Bhattacharya S, Hoad G, Horgan GW, Hamilton M, Haggarty P. Epigenetic status in the offspring of spontaneous and assisted conception. Hum Reprod. 2014 Jul;29(7):1452-8. doi: 10.1093/humrep/deu094. Epub 2014 May 8.

  PMID: 24812310 BACKGROUND

• Lorgen-Ritchie M, Murray AD, Ferguson-Smith AC, Richards M, Horgan GW, Phillips LH, Hoad G, Gall I, Harrison K, McNeill G, Ito M, Haggarty P. Imprinting methylation in SNRPN and MEST1 in adult blood predicts cognitive ability. PLoS One. 2019 Feb 1;14(2):e0211799. doi: 10.1371/journal.pone.0211799. eCollection 2019.

  PMID: 30707743 BACKGROUND

• Masser DR, Stanford DR, Freeman WM. Targeted DNA methylation analysis by next-generation sequencing. J Vis Exp. 2015 Feb 24;(96):52488. doi: 10.3791/52488.

  PMID: 25741966 BACKGROUND

• Dighe MK, Frederick IO, Andersen HF, Gravett MG, Abbott SE, Carter AA, Algren H, Rocco DA, Waller SA, Sorensen TK, Enquobahrie D, Blakey I, Knight HE, Cheikh Ismail L; International Fetal and Newborn Growth Consortium for the 21st Century. Implementation of the INTERGROWTH-21st Project in the United States. BJOG. 2013 Sep;120(Suppl 2):123-8, v. doi: 10.1111/1471-0528.12126. Epub 2013 Jul 11.

  PMID: 23841827 BACKGROUND

• Weisenberger D, Van Den Berg D, Pan F, Berman B, Laird P. Comprehensive DNA methylation analysis on the Illumina Infinium assay platform. Illumina, San Diego. 2008.

  BACKGROUND

• Fenson L, Pethick S, Renda C, Cox JL, Dale PS, Reznick JS. Short-form versions of the MacArthur communicative development inventories. Applied Psycholinguistics. 2000;21(1):95-116.

  BACKGROUND

• Zeisel SH, Mar MH, Howe JC, Holden JM. Concentrations of choline-containing compounds and betaine in common foods. J Nutr. 2003 May;133(5):1302-7. doi: 10.1093/jn/133.5.1302.

  PMID: 12730414 BACKGROUND

• Patterson KY, Bhagwat SA, Williams JR, Howe JC, Holden J, Zeisel S, et al. USDA database for the choline content of common foods, release two. Nutrient Data Laboratory, Beltsville Human Nutrition Research Center, ARS, USDA. 2008.

  BACKGROUND

• Cho E, Zeisel SH, Jacques P, Selhub J, Dougherty L, Colditz GA, Willett WC. Dietary choline and betaine assessed by food-frequency questionnaire in relation to plasma total homocysteine concentration in the Framingham Offspring Study. Am J Clin Nutr. 2006 Apr;83(4):905-11. doi: 10.1093/ajcn/83.4.905.

  PMID: 16600945 BACKGROUND

• Mhila G, DeRenzi B, Mushi C, Wakabi T, Steele M, Dhaldialla P, et al. Using mobile applications for community-based social support for chronic patients. Health Informatics in Africa. 2009.

  BACKGROUND

• Sethi V, Tiwari K, Sareen N, Singh S, Mishra C, Jagadeeshwar M, Sunitha K, Kumar SV, de Wagt A, Sachdev HPS. Delivering an Integrated Package of Maternal Nutrition Services in Andhra Pradesh and Telangana (India). Food Nutr Bull. 2019 Sep;40(3):393-408. doi: 10.1177/0379572119844142. Epub 2019 Jun 16.

  PMID: 31204503 BACKGROUND

• Lutter CK, Iannotti LL, Stewart CP. Cracking the egg potential during pregnancy and lactation. Sight Life. 2016;30:75-81.

  BACKGROUND

• Jacobson SW, Carter RC, Molteno CD, Stanton ME, Herbert JS, Lindinger NM, Lewis CE, Dodge NC, Hoyme HE, Zeisel SH, Meintjes EM, Duggan CP, Jacobson JL. Efficacy of Maternal Choline Supplementation During Pregnancy in Mitigating Adverse Effects of Prenatal Alcohol Exposure on Growth and Cognitive Function: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Alcohol Clin Exp Res. 2018 Jul;42(7):1327-1341. doi: 10.1111/acer.13769. Epub 2018 Jun 15.

  PMID: 29750367 BACKGROUND

• Yan J, Jiang X, West AA, Perry CA, Malysheva OV, Devapatla S, Pressman E, Vermeylen F, Stabler SP, Allen RH, Caudill MA. Maternal choline intake modulates maternal and fetal biomarkers of choline metabolism in humans. Am J Clin Nutr. 2012 May;95(5):1060-71. doi: 10.3945/ajcn.111.022772. Epub 2012 Mar 14.

  PMID: 22418088 BACKGROUND

MeSH Terms

Conditions

Weight Gain; Anemia, Iron-Deficiency; Birth Weight; Folic Acid Deficiency; Vitamin B 12 Deficiency; Vitamin A Deficiency; Parasitic Diseases; Escherichia coli Infections; Salmonella Infections; Dysentery, Bacillary; Protozoan Infections

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Infections; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Dysentery; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Umi Fahmida, Dr.

  SEAMEO RECFON

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Model Details: A total of 653 pregnant women will be recruited from 40 villages in three sub-districts. Pregnant women will be randomly allocated into the intervention or control groups. Pregnant women in the intervention group will receive boiled eggs three times per week from 2nd trimester (16-20 weeks) until delivery.

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: January 5, 2021
• Study Start: February 12, 2021
• Primary Completion: May 1, 2024
• Study Completion: September 30, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)