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

Phase 3

• Conditions: Adolescents; Anemia; Pregnancy; Empowerment
• Interventions: Dietary Supplement: Multiple micronutrients (UNIMMAP composition); Behavioral: Life skills based education

• Registration Number: NCT03287882
• Lead Sponsor: Aga Khan University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-30
• Study First Submitted: 2017-08-21
• Study First Submitted QC: 2017-09-15
• Study First Posted: 2017-09-19
• Primary Completion: 2021-03-12
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-07-27
• Study Completion: 2022-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 25447

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MMN supplementation and life skills education	Multiple micronutrients (UNIMMAP composition)	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
MMN supplementation and life skills education	Life skills based education	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

Primary Outcome Measures

Name	Time	Method
Anemia status	0, 12*, 24 months (*in subgroup only)	Hemoglobin concentration \<12 g/dL
Low birth weight	At birth	Birth weight \<2500 g

Secondary Outcome Measures

Name	Time	Method
Anthropometrics: height (women)	Preconception: enrolment, 6 months*, 1 year, 2 years (*in subgroup only); Pregnancy: 4-12 weeks, 32 weeks; Postpartum: 1 week, 6 months
Anthropometrics: middle upper arm circumference (women)	Preconception: enrolment, 6 months*, 1 year, 2 years (*in subgroup only); Pregnancy: 4-12 weeks, 32 weeks; Postpartum: 1 week, 6 months
Gestational age	At birth
Birth size: weight	Within 24 hours of birth
Age at marriage	Enrolment, 1 year, 2 years
Dietary intake: 24-hour recall (subgroup of women)	Preconception: enrolment; Pregnancy: 4-12 weeks, 32 weeks
Biomarkers: serum ferritin, serum transferrin receptor, hepcidin, serum retinol, serum 25(OH)D, alpha-glycolytic protein, C-reactive protein (women)	Preconception (subgroup only): enrolment, 1 year, 2 years; Pregnancy: 4-12 weeks, 32 weeks; Postpartum: 1 week
Stillbirth	At birth
Birth size: length	Within 24 hours of birth
Anthropometrics: weight (women)	Preconception: enrolment, 6 months*, 1 year, 2 years (*in subgroup only); Pregnancy: 4-12 weeks, 32 weeks; Postpartum: 1 week, 6 months
Small for gestational age	At birth
Birth size: head circumference	Within 24 hours of birth
Infant growth: length	1, 3, 6, 9, 12 months
Preterm birth	At birth
Birth size: middle upper arm circumference	Within 24 hours of birth
Birth defects	At birth
Infant growth: middle upper arm circumference	1, 3, 6, 9, 12 months
Infant growth: weight	1, 3, 6, 9, 12 months
Infant growth: head circumference	1, 3, 6, 9, 12 months
Completion of 10th grade education	Enrolment, 1 year, 2 years
Use of sanitary pad during last menstrual period	Enrolment, 1 year, 2 years

Trial Locations

Locations (1)

Matiari Research and Training Centre; 🇵🇰 Matiari, Sindh, Pakistan