- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05365698
Supporting Optimal Infant, Young Child and Maternal Nutrition and Health in Jordan: An Evaluation of the CHN Program
A Quantitative Evaluation of the Community Health and Nutrition (CHN) Program in Jordan
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Breastfeeding (BF) plays an important foundation for a healthy and well-developed child, and complementary feeding (CF) builds upon this foundation. Appropriate timing and introduction of high-quality complementary foods are key to sound infant, young child feeding (IYCF) practices. There is compelling evidence that BF and CF are crucial for the growth and development of a child, and in preventing malnutrition. Given this context, the USAID-supported "Community Health and Nutrition" (CHN) is being implemented in three governorates (Amman, Karak, Zarqa) of Jordan to improve the nutritional status of pregnant and lactating women (PLW) and children under the age of two years. The program will fulfill this goal by implementing activities to support improvement in IYCF practices, increase adoption of optimal family planning practices and maternal, infant, and young child nutrition (MIYCN) practices, and by improving health care provider support for proper IYCF practices and use of modern contraceptives methods (MCMs).
The purpose of the comprehensive evaluation is to assess USAID supported Community Health and Nutrition (CHN) program's ability to effect change. The evaluation will assess the effectiveness of CHN in influencing the knowledge, attitudes, practices, motivation, and support of health care providers, as well as the behavior change in pregnant and lactating women of reproductive age and their infants/young children thus supporting optimal maternal, infant and young child nutrition and health.
The study will utilize a cluster-randomized stratified stepped wedge design with two steps and two strata (cohort I and cohort 2). The stepped wedge study design is a staggered rollout design in which treatments are introduced to clusters at different time points. This design is particularly well suited for evaluating large-scale programs, like CHN, that roll out the intervention across clusters in phases. The use of strata (stratification) ensures representation of both regional and facility-level differences across the two cohorts.
The investigators will conduct 4 repeat annual cross-sectional surveys on women of reproductive age who are pregnant or are lactating and have a child under 2 years of age. Women will be recruited in the facilities and data will be collected at 12-month intervals. They will also conduct 3 repeat annual cross-sectional surveys on service providers (health care providers and community health agents) who work at these health facilities and within districts that are targets of the CHN program.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Shibani Ghosh, PhD
- Phone Number: 6176363771
- Email: shibani.ghosh@tufts.edu
Study Contact Backup
- Name: Robin Shrestha, MSc
- Phone Number: 6174607564
- Email: robin.shrestha@tufts.edu
Study Locations
-
-
-
Amman, Jordan
- Recruiting
- Mindset
-
Contact:
- Rana Samara
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Jordanian Pregnant women and lactating women between 18 to 49 years who have a child under two years of age and are visiting a participating health facility targeted by the CHN program will be eligible to participate in the comprehensive evaluation.
Healthcare providers and community based agents from the participating health facility targeted by the CHN program will be eligible to participate in the service providers' evaluation
Description
Inclusion Criteria:
- Pregnant and Lactating women with child under 2 years:
Currently a beneficiary of CHN (except at baseline, prior to CHN implementation) Pregnant or lactating women (18-49 years) with children under the age of two years Willing to participate in the study and able to provide informed consent Currently lives within the study area
- Service providers:
Currently working in a CHN accredited social franchise facility Currently working in a maternal and child health department and actively providing services to PLWs Willing to participate in the study Received training from CHN on integrated maternal and child nutrition and healthcare services
Exclusion Criteria:
- Pregnant and Lactating Women with child under 2 years Not willing to participate or provide informed consent Not living in the study area
- Service providers No specific exclusion criteria
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cohort I
randomly assigned 12 health facilities (treatment/intervention group) that will have access to CHN program components
|
The "Community Health and Nutrition" supported by the United States Agency for International Development (USAID) will be implemented by an international NGO, FHI 360.
The goal of the Community Health and Nutrition (CHN) program is to improve the nutritional status of pregnant and lactating women (PLW) and children under the age of two years in the target areas of the Hashemite Kingdom of Jordan.
The program will fulfill this goal by implementing activities to support improvements in IYCF practices, increase adoption of optimal family planning practices and maternal, infant and young child nutrition (MIYCN) practices, and by improving health care provider support for proper IYCF practices and use of modern contraceptive methods.
|
Cohort II
randomly assigned 12 health facilities that will serve as a control for the first year of the program implementation and then transition into the intervention/treatment group
|
The "Community Health and Nutrition" supported by the United States Agency for International Development (USAID) will be implemented by an international NGO, FHI 360.
The goal of the Community Health and Nutrition (CHN) program is to improve the nutritional status of pregnant and lactating women (PLW) and children under the age of two years in the target areas of the Hashemite Kingdom of Jordan.
The program will fulfill this goal by implementing activities to support improvements in IYCF practices, increase adoption of optimal family planning practices and maternal, infant and young child nutrition (MIYCN) practices, and by improving health care provider support for proper IYCF practices and use of modern contraceptive methods.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diet Diversity in Pregnant and Lactating women
Time Frame: 2024
|
Percentage of pregnant and lactating women meeting the minimum dietary diversity for women metric (MDDW)
|
2024
|
Early initiation of breastfeeding
Time Frame: 2024
|
Percentage of women who initiate breastfeeding within the first hour of birth
|
2024
|
Exclusive breastfeeding
Time Frame: 2024
|
Percentage of women who exclusively breastfeed their infants from birth to 6 months of age
|
2024
|
Median duration of exclusive breastfeeding
Time Frame: 2024
|
Increased median duration of exclusive breastfeeding (months) in infants aged 0-6 months
|
2024
|
Improved nutritionally adequate diet and safe complementary feeding in infants and young children 6-23 months
Time Frame: 2021
|
Percentage of children aged 6-23 months achieving a minimum acceptable diet (MAD)
|
2021
|
Improved post party family planning
Time Frame: 2024
|
Percentage of women using modern contraceptive improved postpartum practice on the use of modern contraceptive methods
|
2024
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shibani Ghosh, PhD, Tufts University
Study record dates
Study Major Dates
Study Start (Actual)
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
Other Study ID Numbers
- 00001816
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
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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