Clinical trial NCT06362837: Evaluation of REACTS-IN, an Intervention to Improve Nutrition, Hygiene, and Sexual and Reproductive Health Services
Official title: Realizing Gender Equality, Attitudinal Change & Transformative Systems in Nutrition (REACTS-IN)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stunting
Gender Equality
Acceptability of Health Care
Diet; Deficiency
Empowerment
Keywords: nutrition
gender equity
health services
sexual and reproductive rights
dietary diversity
anthropometry
sexual and reproductive health services
WASH
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: World Vision Canada
name: Global Affairs Canada
First posted: 2024-04-12
Enrollment: 13500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Gender equality
timeFrame: Change between baseline and study completion, an average of 5 years
measure: Child anthropometry
timeFrame: Change between baseline and study completion, an average of 5 years
Secondary outcomes:
measure: Antenatal care
timeFrame: Change between baseline and study completion, an average of 5 years
measure: Contraception use by women and partners
timeFrame: Change between baseline and study completion, an average of 5 years
measure: Child diet
timeFrame: Change between baseline and study completion, an average of 5 years
measure: Sexual and reproductive health services for adolescents
timeFrame: Change between baseline and study completion, an average of 5 years
measure: Gender equitable health services for nutrition, health, and sexual and reproductive health
timeFrame: Change between baseline and study completion, an average of 5 years
measure: Exclusive breastfeeding
timeFrame: Change between baseline and study completion, an average of 5 years
measure: Use of family planning
timeFrame: Change between baseline and study completion, an average of 5 years
measure: adolescent knowledge of nutrition, menstrual hygiene, and sexual and reproductive health
timeFrame: Change between baseline and study completion, an average of 5 years
measure: maternal knowledge on nutrition
timeFrame: Change between baseline and study completion, an average of 5 years
measure: Attended birth deliveries
timeFrame: Change between baseline and study completion, an average of 5 years
measure: maternal knowledge of family planning
timeFrame: Change between baseline and study completion, an average of 5 years
measure: maternal knowledge of exclusive breastfeeding
timeFrame: Change between baseline and study completion, an average of 5 years
measure: mothers planting biofortified crops
timeFrame: Change between baseline and study completion, an average of 5 years
measure: mothers planting nutrient dense local vegetables
timeFrame: Change between baseline and study completion, an average of 5 years
measure: mothers planting trees
timeFrame: Change between baseline and study completion, an average of 5 years
measure: hygenic toilets
timeFrame: Change between baseline and study completion, an average of 5 years
measure: community health worker visit
timeFrame: Change between baseline and study completion, an average of 5 years
measure: Adolescent iron folic acid supplements
timeFrame: Change between baseline and study completion, an average of 5 years
measure: health facility
timeFrame: Change between baseline and study completion, an average of 5 years
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Brac University
city: Nairobi
country: Kenya
facility: Connar Consultants
city: Ifakara
country: Tanzania
facility: Ifakara Health Institute
Study officials:
affiliation: McGill University
name: Grace S Marquis, PhD
role: PRINCIPAL_INVESTIGATOR
References: