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

Prospective, Cluster Randomized Effectiveness Trial of Multiple Micronutrient Supplementation and Life Skills Education Provided From Preconception on Health and Nutrition Outcomes of Young, Reproductive-age Pakistani Women (15-24 Years)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Anemia; Pregnancy; Adolescents; Empowerment
• Intervention / Treatment: Dietary supplement: Multiple micronutrients (UNIMMAP composition); Behavioral: Life skills based education

• Study Type: Interventional
• Enrollment (Actual): 25447
• Phase: Phase 3

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Matiari, Sindh, Pakistan
      • Matiari Research and Training Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care; Preconception period: none; 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; Postpartum period: daily iron and folic acid supplementation to 6 months postpartum
Experimental: MMN supplementation and life skills education; Preconception period: twice-weekly MMN supplementation and bi-monthly group session including life skill based education materials; 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; Postpartum period: daily MMN supplementation to 6 months postpartum	Dietary supplement: Multiple micronutrients (UNIMMAP composition); The intervention is an oral tablet containing 15 different vitamins and minerals at the UNIMMAP composition (includes 30 mg iron, 400 μg folic acid, 15 mg zinc, 2 mg copper, 65 μg selenium, 800 μg RE vitamin A, 1.4 mg vitamin B1, 1.4 mg vitamin B2, 18 mg niacin, 1.9 mg vitamin B6, 2.6 μg vitamin B12, 70 mg vitamin C, 5 μg vitamin D, 10 mg vitamin E and 150 μg iodine). Each tablet is small (approximately 10 mm diameter) and has been procured using the UNICEF supply catalogue. A single MMN supplementation dose will consist of a single tablet.; Other Names: UNICEF, Micronutrient tabs, pregnancy/PAC-1000; Behavioral: Life skills based education; The life skills based education will be provided bi-monthly in the format of a group session throughout the preconception period. Three topic areas related to empowerment have been prioritized, including preventing early marriage; personal and menstrual hygiene practices; and the importance of nutrition to good health. Integrated within these topics will be messages related to the importance of continuing one's education, mental health, gender norms and equality, decision making, advocacy, resiliency, participation, communication skills, facing challenges, agency, conflict resolution, and the prevention of violence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anemia status	Hemoglobin concentration <12 g/dL	0, 12*, 24 months (*in subgroup only)
Low birth weight	Birth weight <2500 g	At birth

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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
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
Gestational age	At birth
Preterm birth	At birth
Stillbirth	At birth
Small for gestational age	At birth
Birth size: length	Within 24 hours of birth
Birth size: head circumference	Within 24 hours of birth
Birth size: middle upper arm circumference	Within 24 hours of birth
Birth size: weight	Within 24 hours of birth
Birth defects	At birth
Infant growth: length	1, 3, 6, 9, 12 months
Infant growth: head circumference	1, 3, 6, 9, 12 months
Infant growth: middle upper arm circumference	1, 3, 6, 9, 12 months
Infant growth: weight	1, 3, 6, 9, 12 months
Age at marriage	Enrolment, 1 year, 2 years
Completion of 10th grade education	Enrolment, 1 year, 2 years
Use of sanitary pad during last menstrual period	Enrolment, 1 year, 2 years
Dietary intake: 24-hour recall (subgroup of women)	Preconception: enrolment; Pregnancy: 4-12 weeks, 32 weeks

Collaborators and Investigators

• Sponsor: Aga Khan University
• Collaborators: The Hospital for Sick Children; Bill and Melinda Gates Foundation; National Program for Family Planning and Primary Health Care
• Investigators: Principal Investigator: Zulfiqar A Bhutta, PhD, MBBS, Aga Khan University

Publications and helpful links

General Publications

• Baxter JB, Kortenaar JL, Wasan Y, Hussain A, Soofi SB, Ahmed I, Bhutta ZA. Age-Based Anthropometric Cutoffs Provide Inconsistent Estimates of Undernutrition: Findings from a Cross-Sectional Assessment of Late-Adolescent and Young Women in Rural Pakistan. Curr Dev Nutr. 2021 Nov 10;5(11):nzab130. doi: 10.1093/cdn/nzab130. eCollection 2021 Nov.
• Bhutta ZA. Reply to NF Krebs and KM Hambidge. Am J Clin Nutr. 2019 Aug 1;110(2):521-522. doi: 10.1093/ajcn/nqz078. No abstract available.
• Bhutta ZA. Balancing the benefits of maternal nutritional interventions; time to put women first! Am J Clin Nutr. 2019 Feb 1;109(2):249-250. doi: 10.1093/ajcn/nqy336. No abstract available.
• Baxter JB, Wasan Y, Soofi SB, Suhag Z, Bhutta ZA. Effect of life skills building education and micronutrient supplements provided from preconception versus the standard of care on low birth weight births among adolescent and young Pakistani women (15-24 years): a prospective, population-based cluster-randomized trial. Reprod Health. 2018 May 31;15(1):104. doi: 10.1186/s12978-018-0545-0.
• Baxter JB, Wasan Y, Soofi SB, Suhag Z, Bhutta ZA. Feasibility and effect of life skills building education and multiple micronutrient supplements versus the standard of care on anemia among non-pregnant adolescent and young Pakistani women (15-24 years): a prospective, population-based cluster-randomized trial. Reprod Health. 2018 May 30;15(1):103. doi: 10.1186/s12978-018-0547-y.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2017
• Primary Completion (Actual): March 12, 2021
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: August 21, 2017
• First Submitted That Met QC Criteria: September 15, 2017
• First Posted (Actual): September 19, 2017

Study Record Updates

• Last Update Posted (Actual): July 27, 2021
• Last Update Submitted That Met QC Criteria: July 26, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: low birth weight; preconception supplementation; multiple micronutrients
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Trace Elements
• Other Study ID Numbers: 4324-Ped-ERC-16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No