Adolescents, Anemia, Empowerment, Pregnancy
Conditions
Keywords
preconception supplementation, multiple micronutrients, low birth weight
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.
Interventions
DIETARY_SUPPLEMENTMultiple 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.
BEHAVIORALLife 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.
Sponsors
The Hospital for Sick Children
National Program for Family Planning and Primary Health Care
Bill and Melinda Gates Foundation
Aga Khan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Some investigators are blinded to the allocation of the intervention, and all study data collectors are blinded.
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 24 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anemia status | 0, 12*, 24 months (*in subgroup only) | Hemoglobin concentration \<12 g/dL |
| Low birth weight | At birth | Birth weight \<2500 g |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| Birth size: weight | Within 24 hours of birth |
| 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 |
Countries
Pakistan
Outcome results
None listed