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

• Sponsor: Aga Khan University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03287882
• Collaborator: The Hospital for Sick Children (Other), National Program for Family Planning and Primary Health Care (Other), Bill and Melinda Gates Foundation (Other)
• Enrollment: 25,447
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 55.1
• Patients Per Site Per Month: 461.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adolescents; Anemia; Pregnancy; Empowerment	Dietary Supplement: Multiple micronutrients (UNIMMAP composition); Behavioral: Life skills based education	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 25447 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Masking Description: Some investigators are blinded to the allocation of the intervention, and all study data collectors are blinded.
• Primary Purpose: Prevention
• Official Title: 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)
• Actual Study Start Date: Jun 30, 2017
• Actual Primary Completion Date: Mar 12, 2021
• Anticipated Study Completion Date: Feb 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Anemia status [0, 12*, 24 months (*in subgroup only)]

   Hemoglobin concentration <12 g/dL

2. Low birth weight [At birth]

   Birth weight <2500 g

Secondary Outcome Measures

1. 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]

2. 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]

3. 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]

4. 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]

5. Gestational age [At birth]

6. Preterm birth [At birth]

7. Stillbirth [At birth]

8. Small for gestational age [At birth]

9. Birth size: length [Within 24 hours of birth]

10. Birth size: head circumference [Within 24 hours of birth]

11. Birth size: middle upper arm circumference [Within 24 hours of birth]

12. Birth size: weight [Within 24 hours of birth]

13. Birth defects [At birth]

14. Infant growth: length [1, 3, 6, 9, 12 months]

15. Infant growth: head circumference [1, 3, 6, 9, 12 months]

16. Infant growth: middle upper arm circumference [1, 3, 6, 9, 12 months]

17. Infant growth: weight [1, 3, 6, 9, 12 months]

18. Age at marriage [Enrolment, 1 year, 2 years]

19. Completion of 10th grade education [Enrolment, 1 year, 2 years]

20. Use of sanitary pad during last menstrual period [Enrolment, 1 year, 2 years]

21. Dietary intake: 24-hour recall (subgroup of women) [Preconception: enrolment; Pregnancy: 4-12 weeks, 32 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 24 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Matiari Research and Training Centre	Matiari	Sindh	Pakistan

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Zulfiqar A Bhutta, PhD, MBBS, Aga Khan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr Zulfiqar Ahmed Bhutta, Director, Centre of Excellence in Women and Child Health, Aga Khan University
• ClinicalTrials.gov Identifier: NCT03287882
• Other Study ID Numbers: 4324-Ped-ERC-16
• First Posted: Sep 19, 2017
• Last Update Posted: Jul 27, 2021
• Last Verified: Jul 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dr Zulfiqar Ahmed Bhutta, Director, Centre of Excellence in Women and Child Health, Aga Khan University: preconception supplementation; multiple micronutrients; low birth weight
• Additional relevant MeSH terms: Micronutrients; Trace Elements

Study Results

No Results Posted as of Jul 27, 2021