Evaluation of REACTS-IN, an Intervention to Improve Nutrition, Hygiene, and Sexual and Reproductive Health Services

Stunting Clinical Trial

— REACTS-IN  

Official title:

Realizing Gender Equality, Attitudinal Change & Transformative Systems in Nutrition (REACTS-IN)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06362837
• Other study ID #: P0117910-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: May 24, 2030

Study information

• Verified date: April 2024
• Source: McGill University
• Contact: Grace S Marquis, PhD
• Phone: 1-514-398-7839
• Email: grace.marquis[@]mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 and comparison communities, schools, and health facilities. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 13500
• Est. completion date: May 24, 2030
• Est. primary completion date: June 30, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Acceptability of Health Care
• Diet; Deficiency
• Empowerment
• Malnutrition
• Stunting

Intervention

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

Dietary Supplement:
• school-based iron-folic acid supplement program
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.

Behavioral:
• Health service training on equitable access to nutrition, health, and sexual and reproductive services
Training and support activities to make gender-equitable nutrition, health, and sexual and reproductive services in the health facilities

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

Locations

Country	Name	City	State
Bangladesh	Brac University	Dhaka
Kenya	Connar Consultants	Nairobi
Tanzania	Ifakara Health Institute	Ifakara

Sponsors (3)

Lead Sponsor	Collaborator
McGill University	Global Affairs Canada, World Vision Canada

Countries where clinical trial is conducted

Bangladesh,  Kenya,  Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Antenatal care	Percent of mothers of children 0-6 months who attended at least four ante-natal visits during the last pregnancy from skilled health personnel	Change between baseline and study completion, an average of 5 years
Secondary	Contraception use by women and partners	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	Change between baseline and study completion, an average of 5 years
Secondary	Child diet	Percent of children 6-23.9 months of age, who receive minimum dietary diversity and minimum meal frequency	Change between baseline and study completion, an average of 5 years
Secondary	Sexual and reproductive health services for adolescents	Percent of adolescent girls (10-19) who report that they were offered sexual and reproductive health services	Change between baseline and study completion, an average of 5 years
Secondary	Gender equitable health services for nutrition, health, and sexual and reproductive health	Percent of health facilities promoting gender equitable and responsive nutrition, health, and sexual and reproductive services	Change between baseline and study completion, an average of 5 years