Clinical trial NCT06815315: Evaluating of the Impact of Micronutrient Interventions Among Adolescents in Mozambique
Official title: A Formative, Mixed-Methods Evaluation Assessing the Acceptability, Feasibility, and Effectiveness of Micronutrient Interventions Among Adolescents in Mozambique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Keywords: Vitamins
Supplements
Iron
Folic Acid
Mozambique
Micronutrients
Adolescents
Lead sponsor: World Vision US
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 490
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We conducted a two-arm cluster-randomized trial in three secondary schools, enrolling 28 girls' clubs (14 per arm), with each club consisting of approximately 18 girls aged 13 to 20 years. Using constrained sampling to balance for age and school, clubs were randomly assigned to one of two intervention groups: (1) Multiple Micronutrient Supplementation (MMS) for five months plus a Nutrition Curriculum, or (2) Iron and Folic Acid Supplementation (IFAS) plus a Nutrition Curriculum.
Primary purpose: PREVENTION

Brief summary: This purpose of this study is to assess effects of iron and folic acid supplementation and multiple micronutrient supplementation on anemia status and the impact of a nutrition curriculum on diet diversity and anemia knowledge among adolescent girls.

Detailed description: This study aimed to implement and evaluate micronutrient supplementation interventions to improve adolescent nutrition, health, and education in Mozambique. In conjunction with the Mozambique Ministries of Health, Education and Culture, we conducted a two-arm cluster-randomized trial in three secondary schools, enrolling 28 girls' clubs (14 per arm). Each club was comprised of around 18 girls aged 13 to 20 years. Using constrained sampling to balance for age and school, clubs were randomly assigned to one of two intervention groups: 1) Multiple Micronutrient Supplementation (MMS) for five months plus a Nutrition Curriculum, or 2) Iron and Folic Acid Supplementation (IFAS) plus a Nutrition Curriculum. Girls enrolled in the MMS arm consumed supplements daily for 4 months at home and weekly nutrition messages delivered through the clubs. Girls enrolled in the IFAS arm consumed supplements once a week for 4 months at school (the standard of care) and weekly nutrition messages delivered through the clubs. The study evaluated the effects of MMS and IFAS on anemia status and the impact of the nutrition curriculum on diet diversity and anemia knowledge.

Eligibility criteria: Inclusion Criteria:

Adolescents aged 13-20 years Enrolled in secondary school at study initiation Member of an IMPACT+ Girls Club at one of the participating schools Consent provided by the parent Assent provided by the adolescent

Exclusion Criteria:

No informed consent from parent or assent from adolescent Self-reported pregnancy

Primary outcomes:
measure: Anemia Status
timeFrame: 6 months
Secondary outcomes:
measure: Anemia Knowledge
timeFrame: 6 months
measure: Minimum Dietary Diversity Score
timeFrame: 6 months
Other outcomes:
Locations:
city: Monapo
country: Mozambique
facility: World Vision Monapo Field Office
state: Nampula Province
Study officials:
affiliation: World Vision International
name: Sarah A Bauler, DrPH(c)
role: PRINCIPAL_INVESTIGATOR
References: