Egg Intervention During Pregnancy in Indonesia (PRECODE)

SEAMEO Regional Centre for Food and Nutrition

Status: Active, not recruiting

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

Treatments: Dietary Supplement: Egg intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04694235

AASH Egg intervention

Details and patient eligibility

About

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

Full description

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).

Enrollment: 702 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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702 participants in 2 patient groups

Observational cohort (control group)

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Dietary Supplement: Egg intervention