Egg Intervention During Pregnancy in Indonesia

NCT ID: NCT04694235

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

702 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-12

Study Completion Date

2024-09-30

Brief Summary

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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

Detailed Description

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The study aims to assess the impact of improving dietary quality during pregnancy on the epigenetic and stunting related outcomes in infants. The open-label intervention study would be conducted alongside the observational study in the same study setting by recruitment of additional number (n=153) of pregnant women. Thus, a total of 653 pregnant women would be enrolled in the study; 153 women would be randomized to intervention arm and 500 to the control arm who would form an observational cohort of women and newborns as described above. The intervention group women will be provided one egg three times per week from recruitment (2nd trimester) until term. The control group women will receive standard intervention in the form of Ante Natal Care from village midwives or Public Health Centre (IFA tablet, calcium tablet, nutrition counselling).

Conditions

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Observational cohort (control group)

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention group

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.

Group Type EXPERIMENTAL

Egg intervention

Intervention Type 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.

Interventions

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Egg intervention

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 Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* She is expecting multiple births.
* She has a known egg allergy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role collaborator

University of Aberdeen

OTHER

Sponsor Role collaborator

University of Brighton

OTHER

Sponsor Role collaborator

University College, London

OTHER

Sponsor Role collaborator

Royal Veterinary College

UNKNOWN

Sponsor Role collaborator

Birkbeck, University of London

OTHER

Sponsor Role collaborator

The International Livestock Research Institute (ILRI)

OTHER

Sponsor Role collaborator

Cheikh Anta Diop University, Senegal

OTHER

Sponsor Role collaborator

National Institute of Nutrition, India

UNKNOWN

Sponsor Role collaborator

International Centre for Research in Agroforestry

UNKNOWN

Sponsor Role collaborator

Science Made Simple

UNKNOWN

Sponsor Role collaborator

Liverpool School of Tropical Medicine

OTHER

Sponsor Role collaborator

International Initiative for Impact Evaluation

OTHER

Sponsor Role collaborator

Digital Green Foundation

UNKNOWN

Sponsor Role collaborator

SOAS, University of London

UNKNOWN

Sponsor Role collaborator

University of Sheffield

OTHER

Sponsor Role collaborator

SEAMEO Regional Centre for Food and Nutrition

OTHER

Sponsor Role lead

Responsible Party

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Dr.Umi Fahmida

Senior Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Umi Fahmida, Dr.

Role: PRINCIPAL_INVESTIGATOR

SEAMEO RECFON

Locations

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Aikmel, Sakra, and Sikur Subdistrict

Mataram, West Nusa Tenggara, Indonesia

Site Status

Countries

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Indonesia

References

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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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
PMID: 24028891 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23151531 (View on PubMed)

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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
PMID: 30707743 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25741966 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23841827 (View on PubMed)

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.

Reference Type 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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 12730414 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 16600945 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 31204503 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 29750367 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22418088 (View on PubMed)

Other Identifiers

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AASH Egg intervention

Identifier Type: -

Identifier Source: org_study_id

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