NCT06362837

Brief Summary

This is an independent evaluation of World VIsion's 7-year quasi-experimental intervention to improve nutrition, nutrition-related rights and gender equality for women, adolescent girls, and children under five years of age in rural Bangladesh, Kenya, and Tanzania. The evaluation will collect baseline, midline, and end-line data from intervention communities, schools, and health facilities. Only baseline and endline will be collected on the comparison communities. The evaluation objectives are to test if the intervention improved indicators for (i) child anthropometry, (ii) maternal and child dietary practices, (iii) women's empowerment, and (iv) equitable health service access for nutrition and sexual and reproductive needs. The evaluation analysis will take into account gender differences in the indicators.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13,500

participants targeted

Target at P75+ for not_applicable

Timeline
45mo left

Started Sep 2024

Longer than P75 for not_applicable

Geographic Reach
3 countries

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Sep 2024Dec 2029

First Submitted

Initial submission to the registry

April 4, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 12, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2029

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

4.8 years

First QC Date

April 4, 2024

Last Update Submit

April 27, 2026

Conditions

Keywords

nutritiongender equityhealth servicessexual and reproductive rightsdietary diversityanthropometrysexual and reproductive health servicesWASH

Outcome Measures

Primary Outcomes (2)

  • Gender equality

    Percent of households with children \< 59.9 mo that have achieved gender equality

    Change between baseline and study completion, an average of 5 years

  • Child anthropometry

    Percent of children 6-59 mo of age who are stunted

    Change between baseline and study completion, an average of 5 years

Secondary Outcomes (19)

  • Antenatal care

    Change between baseline and study completion, an average of 5 years

  • Contraception use by women and partners

    Change between baseline and study completion, an average of 5 years

  • Child diet

    Change between baseline and study completion, an average of 5 years

  • Sexual and reproductive health services for adolescents

    Change between baseline and study completion, an average of 5 years

  • Gender equitable health services for nutrition, health, and sexual and reproductive health

    Change between baseline and study completion, an average of 5 years

  • +14 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Includes multiple activities, depending on country, including support of school-based iron-folic acid supplementation program; promotion of bio-fortified crops (sweet potatoes, beans, rice, corn); training on nutrition, water \& sanitation, gender equity for rural communities through community groups and for health facility staff; support to improve gender-sensitive health services for nutrition, sexual and reproductive health,

Behavioral: Education intervention on nutrition, gender equity, WASH, sexual and reproductive health rightsDietary Supplement: school-based iron-folic acid supplement programBehavioral: Health service training on equitable access to nutrition, health, and sexual and reproductive servicesDietary Supplement: bio-fortified crops

Comparison

NO INTERVENTION

No intervention will take place. Standard of care will be available in the health facilities and schools.

Interventions

The program will help support and promote the school-based programs of weekly iron and folic acid supplementation for adolescent girls, in countries where it is allowed.

Intervention
bio-fortified cropsDIETARY_SUPPLEMENT

The program promotes and distributes bio-fortified crops, including orange-fleshed sweet potatoes, rice, beans, and corn

Intervention

Educational training on nutrition, gender equity, WASH, sexual and reproductive health rights will take place in communities (including schools) for women, men, and adolescents

Intervention

Training and support activities to make gender-equitable nutrition, health, and sexual and reproductive services in the health facilities

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • (i)Women:
  • y of age
  • biological mother of child in the home who is 0-5.9, 6-23.9, or 24-59.9 months
  • has lived in the community for at 12 months
  • (ii) Husbands/partners:
  • no age limit
  • lives in the home with index woman
  • has lived in community for at least 12 months
  • (iii) Adolescents:
  • years
  • male or female
  • has been in target school for at least 6 months
  • lives in the target community
  • (iv) Children:
  • , 6-23.9, or 24-59.9 months

You may not qualify if:

  • (i) Children:
  • no limitation on normal diet or growth (birth defects, illnesses)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Brac University

Dhaka, Bangladesh

RECRUITING

Connar Consultants

Nairobi, Kenya

RECRUITING

Ifakara Health Institute

Ifakara, Tanzania

NOT YET RECRUITING

MeSH Terms

Conditions

Growth DisordersPatient Acceptance of Health CareMalnutritionEmpowermentCoitus

Interventions

Gender EquityTherapeutic IrrigationSexHealth

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsTreatment Adherence and ComplianceHealth BehaviorBehaviorNutrition DisordersNutritional and Metabolic DiseasesSocial BehaviorSexual Behavior

Intervention Hierarchy (Ancestors)

Health InequitiesHealth StatusDemographyPopulation CharacteristicsHydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitationInvestigative TechniquesReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Grace S Marquis, PhD

    McGill University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Grace S Marquis, PhD

CONTACT

Aishat Abdu, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This is a quasi-experimental design for the evaluation of an intervention that is in the community (including schools) as well as in the local health service facilities. The data collection at baseline, midline, and end-line will occur simultaneously in the intervention and comparison selected communities. Comparison communities will not be visited during midline. Participants are unique at each time point.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 4, 2024

First Posted

April 12, 2024

Study Start

September 1, 2024

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations