- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06362837
Evaluation of REACTS-IN, an Intervention to Improve Nutrition, Hygiene, and Sexual and Reproductive Health Services (REACTS-IN)
Realizing Gender Equality, Attitudinal Change & Transformative Systems in Nutrition (REACTS-IN)
Study Overview
Status
Intervention / Treatment
- Behavioral: Education intervention on nutrition, gender equity, WASH, sexual and reproductive health rights
- Dietary supplement: school-based iron-folic acid supplement program
- Behavioral: Health service training on equitable access to nutrition, health, and sexual and reproductive services
- Dietary supplement: bio-fortified crops
Detailed Description
This is an independent evaluation of World VIsion's 7-year quasi-experimental intervention ("Realizing Gender Equality, Attitudinal Change and Transformative Systems in Nutrition", REACTS-IN) 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. REACTS-IN is a multi-sectoral approach, integrating nutrition-related determinants, such as water, sanitation, and hygiene (WASH) interventions and health systems strengthening, to improve access to quality and gender-responsive health systems with increased capacity to prevent and treat malnutrition, especially at the primary health care level. REACTS-IN includes both nutrition-specific (e.g., school-based iron-folic acid supplement program) and nutrition-sensitive (e.g., WASH education) activities delivered through local health systems and/or schools, and communities.
This independent evaluation will include three data collection at baseline, midpoint, and end-line to evaluate the performance indicators for the ultimate and intermediate outcomes. This includes indicators for child anthropometry, maternal and child dietary practices, women's empowerment, and equitable health service access for nutrition and sexual and reproductive needs. The evaluation analysis will take into account gender differences in the indicators.
The data collection will be carried out with intervention communities as well as with comparison communities. The estimated household sample is 463 households (women, husbands, child)/arm/country per time point, selected through a multi-stage cluster sampling methodology. The household baseline survey with a representative sample of mothers with children (0-5.9 mo; 6-23.9 mo; 24-59.9 mo) will be compared to the values at midpoint (to assess initial impact and the need for program adjustments) and at end-line (to assess the total impact of the project). The surveys will include sociodemographic, economic, and environmental information to assess the indicators for the local context. The evaluation also includes a sample of 500 school-going adolescents (250 boys, 250 girls)/arm/country per time point to assess indicators of knowledge about nutrition, menstrual hygiene management, and sexual and reproductive health. Finally, a sample of approximately 24 health staff and community leaders will provide qualitative data on gender-equitable access to services per arm/country for baseline and end-line.
Although the project also is working in Somalia, this independent evaluation does not include data collection in Somalia.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Grace S Marquis, PhD
- Phone Number: 1-514-398-7839
- Email: grace.marquis@mcgill.ca
Study Contact Backup
- Name: Aishat Abdu, PhD
- Email: aishat.abdu@mail.mcgill.ca
Study Locations
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Dhaka, Bangladesh
- Brac University
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Contact:
- Malay K Mridha, PhD
- Email: malay.mridha@bracu.ac.bd
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Nairobi, Kenya
- Connar Consultants
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Contact:
- Elizabeth Kamau, PhD
- Email: ekambu@gmail.com
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Ifakara, Tanzania
- Ifakara Health Institute
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Contact:
- Ester Elisaria, PhD
- Email: eelisaria@ihi.or.tz
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
(i)Women:
- 15-49 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:
- 10-19 years
- male or female
- has been in target school for at least 6 months
- lives in the target community
(iv) Children:
- 0-5.9, 6-23.9, or 24-59.9 months
Exclusion Criteria:
(i) Children:
- no limitation on normal diet or growth (birth defects, illnesses)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
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,
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Educational training on nutrition, gender equity, WASH, sexual and reproductive health rights will take place in communities (including schools) for women, men, and adolescents
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.
Training and support activities to make gender-equitable nutrition, health, and sexual and reproductive services in the health facilities
The program promotes and distributes bio-fortified crops, including orange-fleshed sweet potatoes, rice, beans, and corn
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No Intervention: Comparison
No intervention will take place.
Standard of care will be available in the health facilities.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gender equality
Time Frame: Change between baseline and study completion, an average of 5 years
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Percent of households with children < 59.9 mo that have achieved gender equality
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Change between baseline and study completion, an average of 5 years
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Child anthropometry
Time Frame: Change between baseline and study completion, an average of 5 years
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Percent of children 6-59 mo of age who are stunted
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Change between baseline and study completion, an average of 5 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Antenatal care
Time Frame: Change between baseline and study completion, an average of 5 years
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Percent of mothers of children 0-6 months who attended at least four ante-natal visits during the last pregnancy from skilled health personnel
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Change between baseline and study completion, an average of 5 years
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Contraception use by women and partners
Time Frame: Change between baseline and study completion, an average of 5 years
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Percent of women aged 15-49 years married or in union, who are currently using, or whose sexual partner is using at least one modern contraception method
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Change between baseline and study completion, an average of 5 years
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Child diet
Time Frame: Change between baseline and study completion, an average of 5 years
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Percent of children 6-23.9 months of age, who receive minimum dietary diversity and minimum meal frequency
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Change between baseline and study completion, an average of 5 years
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Sexual and reproductive health services for adolescents
Time Frame: Change between baseline and study completion, an average of 5 years
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Percent of adolescent girls (10-19) who report that they were offered sexual and reproductive health services
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Change between baseline and study completion, an average of 5 years
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Gender equitable health services for nutrition, health, and sexual and reproductive health
Time Frame: Change between baseline and study completion, an average of 5 years
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Percent of health facilities promoting gender equitable and responsive nutrition, health, and sexual and reproductive services
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Change between baseline and study completion, an average of 5 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Grace S Marquis, PhD, McGill University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P0117910-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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