Effect of Micronutrients and Life Skills Education on the Health and Nutrition of Adolescent and Young Women in Pakistan

Aga Khan University

Status and phase: Unknown; Phase 3

Conditions: Anemia; Adolescents; Empowerment; Pregnancy

Treatments: Dietary Supplement: Multiple micronutrients (UNIMMAP composition); Behavioral: Life skills based education

Study type: Interventional

Funder types: Other

Identifiers

NCT03287882

4324-Ped-ERC-16

Details and patient eligibility

About

The primary aims of this study are: 1) To evaluate the impact of supplementation with multiple micronutrients (MMN) from preconception and life skills education among women 15-18.9 years of age at enrolment on the prevalence of anemia in a population setting; and 2) To evaluate the impact of supplementation with MMN from preconception and life skills education among young women 15-24 years of age on the rate of low birth weight (LBW) in a population setting. Infants born to mothers enrolled in the study will be followed for 1 year. This study aims to enrol 25,400 non-pregnant young women in Matiari district. This sample size is anticipated to equate to 1456 births. Participants will be randomized by cluster to receive either MMN supplements and life skills education or the standard of care at enrolment. Clusters have been defined based on health facility catchment areas. MMN supplements will be provided twice weekly during the preconception period, once daily during the pregnancy period, and once daily until 6 months after giving birth during the postpartum period; and a package of life skills education materials will be provided bi-monthly during the preconception period. In addition to the primary outcomes, measurements will include micronutrient status, anthropometrics, birth outcomes, dietary intake and feeding practices, adherence, and indices of empowerment.

Enrollment: 25,447 patients

Sex: Female

Ages: 15 to 24 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Minimum age at enrolment: 15 years
• Maximum age at enrolment: 23 years
• Any marital status
• Intend to comply with study intervention and follow up

Exclusion criteria

• Women participating in other nutrition trials
• Women who intend to leave the study area
• Women who are already pregnant

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25,447 participants in 2 patient groups

Standard of care

No Intervention group

Description:

1. Preconception period: none 2. Pregnancy period: daily iron (60 mg) and folic acid (400 µg) supplementation from confirmation of pregnancy; daily balanced energy protein supplements will additionally be provided to those participants who are underweight at the confirmation of pregnancy for the duration of the pregnancy 3. Postpartum period: daily iron and folic acid supplementation to 6 months postpartum

MMN supplementation and life skills education

Experimental group

Description:

1. Preconception period: twice-weekly MMN supplementation and bi-monthly group session including life skill based education materials 2. Pregnancy period: daily MMN supplementation from confirmation of pregnancy; daily balanced energy protein supplements will additionally be provided to those participants who are underweight at the confirmation of pregnancy for the duration of the pregnancy 3. Postpartum period: daily MMN supplementation to 6 months postpartum

Treatment:

Behavioral: Life skills based education

Dietary Supplement: Multiple micronutrients (UNIMMAP composition)