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

NCT03287882 | Unknown Phase 3 DMC

• 1 other identifier: 4324-Ped-ERC-16
• Study Type: interventional
• Target: 25,447
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescents; Anemia; Pregnancy; Empowerment

Keywords

preconception supplementation; multiple micronutrients; low birth weight

Outcome Measures

Primary Outcomes (2)

• Anemia status

  Hemoglobin concentration \<12 g/dL

  0, 12*, 24 months (*in subgroup only)

• Low birth weight

  Birth weight \<2500 g

  At birth

Secondary Outcomes (21)

• 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

Study Arms (2)

Standard of care

NO INTERVENTION

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

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

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

Interventions

Multiple micronutrients (UNIMMAP composition) DIETARY_SUPPLEMENT

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.

Also known as: UNICEF, Micronutrient tabs, pregnancy/PAC-1000

MMN supplementation and life skills education

Life skills based education BEHAVIORAL

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.

MMN supplementation and life skills education

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Aga Khan University: lead
• The Hospital for Sick Children: collaborator
• National Program for Family Planning and Primary Health Care: collaborator
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Matiari Research and Training Centre

Matiari, Sindh, Pakistan

Location

Related Publications (7)

• Baxter JB, Wasan Y, Daniel AI, Begum K, Hussain A, Iqbal J, Aufreiter S, Beggs MR, Duan L, Greco A, Huang C, Soofi S, Bandsma RH, Bhutta ZA, O'Connor DL. Maternal multiple micronutrient supplementation in rural Pakistan increased some milk micronutrient concentrations, but not infant growth, at three-months postpartum: a randomized controlled trial substudy. Am J Clin Nutr. 2025 Jul;122(1):174-184. doi: 10.1016/j.ajcnut.2025.05.019. Epub 2025 May 21.

  PMID: 40409469 DERIVED

• Baxter JB, Wasan Y, Hussain A, Soofi SB, Ahmed I, Bhutta ZA. Drivers of malnutrition among late adolescent and young women in rural Pakistan: a cross-sectional assessment of the MaPPS trial. BMJ Open. 2023 May 23;13(5):e063734. doi: 10.1136/bmjopen-2022-063734.

  PMID: 37221027 DERIVED

• 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.

  PMID: 34901693 DERIVED

• 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.

  PMID: 31367763 DERIVED

• 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.

  PMID: 30721972 DERIVED

• 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.

  PMID: 29855317 DERIVED

• 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.

  PMID: 29848335 DERIVED

MeSH Terms

Conditions

Anemia; Empowerment

Interventions

United Nations

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

International Agencies; Organizations; Health Care Economics and Organizations

Study Officials

• Zulfiqar A Bhutta, PhD, MBBS

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Some investigators are blinded to the allocation of the intervention, and all study data collectors are blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Centre of Excellence in Women and Child Health

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: September 19, 2017
• Study Start: June 30, 2017
• Primary Completion: March 12, 2021
• Study Completion: February 1, 2022
• Last Updated: July 27, 2021

Record last verified: 2021-07

Locations

PA (1)