EvaluationsNCT05365698
Supporting Optimal Infant, Young Child and Maternal Nutrition and Health in Jordan: An Evaluation of the CHN Program
An observational study of Evaluations, run by Tufts University at 1 site in Jordan.
Trial summary
The purpose of the comprehensive evaluation is to assess USAID supported Community Health and Nutrition (CHN) program's ability to effect change, the comprehensive evaluation will assess the effectiveness of CHN in influencing the knowledge, attitudes, practices, motivation, and support of health care providers, as… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Evaluations
- What is being tested?
- Community Health and Nutrition Program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,145 participants
- Where
- 1 siteJordan
- Study dates
- 3 Oct 2021to 30 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Quantitative Evaluation of the Community Health and Nutrition (CHN) Program in Jordan
The purpose of the comprehensive evaluation is to assess USAID supported Community Health and Nutrition (CHN) program's ability to effect change, the comprehensive 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.
Read the 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.
- Conditions
- Evaluations
- Being tested
- Community Health and Nutrition Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Health and Nutrition ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort I | randomly assigned 12 health facilities (treatment/intervention group) that will have access to CHN program components Receives: Behavioral: Community Health and Nutrition Program | |
| 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 Receives: Behavioral: Community Health and Nutrition Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diet Diversity in Pregnant and Lactating women
Percentage of pregnant and lactating women meeting the minimum dietary diversity for women metric (MDDW)
Measured: 2024
Early initiation of breastfeeding
Percentage of women who initiate breastfeeding within the first hour of birth
Measured: 2024
Exclusive breastfeeding
Percentage of women who exclusively breastfeed their infants from birth to 6 months of age
Measured: 2024
Median duration of exclusive breastfeeding
Increased median duration of exclusive breastfeeding (months) in infants aged 0-6 months
Measured: 2024
Improved nutritionally adequate diet and safe complementary feeding in infants and young children 6-23 months
Percentage of children aged 6-23 months achieving a minimum acceptable diet (MAD)
Measured: 2021
Improved post party family planning
Percentage of women using modern contraceptive improved postpartum practice on the use of modern contraceptive methods
Measured: 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start3 Oct 2021
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EvaluationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shibani Ghosh, Tufts University
- Investigators
- Shibani Ghosh, PhD, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365698
- Sponsor's protocol ID
- 00001816
- Status last verified
- Nov 2023
- First submitted
- 25 Apr 2022
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers outside of Tufts requesting access to the study data will be required to enter into a data-sharing agreement (modeled after examples such as the AHRQ National Inpatient Sample http://www.ahcpr.gov/data/hcup/datause.htm.) This agreement will: (i) require requesters to protect participants' privacy and data confidentiality (and restrictions against attempting to identify study participants), (ii) prohibit the recipient from transferring the data to other users; (iii) require destruction of the data after the planned analyses are completed; (iv) require that the data be used for research purposes only; (v) requires proper acknowledgment of the data resource; and (vi) require IRB approval from the requester's institution.
Publications
Miller LC, Brown R, Safadi R, Ren Y, Alghanmi A, Moore IG, Shrestha R, Webb P, Ghosh S. Her Health Behavior, Her Choice? Decision-Making Power Over Key Health and Nutrition Behaviors Among Pregnant and Lactating Women in Jordan. Matern Child Nutr. 2026 Apr;22(2):e70184. doi: 10.1111/mcn.70184.
PubMed 42024673
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Quantitative Evaluation of the Community Health and Nutrition (CHN) Program in Jordan
- ClinicalTrials.gov ID
- NCT05365698
- Acronym / sponsor ID
- 00001816
- Conditions
- Evaluations
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,145 participants (estimated)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- 3 Oct 2021 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 9 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the comprehensive evaluation is to assess USAID supported Community Health and Nutrition (CHN) program's ability to effect change, the comprehensive 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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort I | – | Behavioral: Community Health and Nutrition Programrandomly assigned 12 health facilities (treatment/intervention group) that will have access to CHN program components |
| Cohort II | – | Behavioral: Community Health and Nutrition Programrandomly 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 |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Age groups
- Adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community Health and Nutrition ProgramThe "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. | Behavioural | Cohort I, Cohort II |
Primary outcome
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)
Early initiation of breastfeeding
Time frame: 2024
Percentage of women who initiate breastfeeding within the first hour of birth
Exclusive breastfeeding
Time frame: 2024
Percentage of women who exclusively breastfeed their infants from birth to 6 months of age
Median duration of exclusive breastfeeding
Time frame: 2024
Increased median duration of exclusive breastfeeding (months) in infants aged 0-6 months
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)
Improved post party family planning
Time frame: 2024
Percentage of women using modern contraceptive improved postpartum practice on the use of modern contraceptive methods
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Derived from this study: PubMed 42024673Miller LC, Brown R, Safadi R, Ren Y, Alghanmi A, Moore IG, Shrestha R, Webb P, Ghosh S. Her Health Behavior, Her Choice? Decision-Making Power Over Key Health and Nutrition Behaviors Among Pregnant and Lactating Women in Jordan. Matern Child Nutr. 2026 Apr;22(2):e70184. doi: 10.1111/mcn.70184.
- Individual participant dataSharing planned: Yes. Researchers outside of Tufts requesting access to the study data will be required to enter into a data-sharing agreement (modeled after examples such as the AHRQ National Inpatient Sample http://www.ahcpr.gov/data/hcup/datause.htm.) This agreement will: (i) require requesters to protect participants' privacy and data confidentiality (and restrictions against attempting to identify study participants), (ii) prohibit the recipient from transferring the data to other users; (iii) require destruction of the data after the planned analyses are completed; (iv) require that the data be used for research purposes only; (v) requires proper acknowledgment of the data resource; and (vi) require IRB approval from the requester's institution.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shibani Ghosh, PhD principal investigator
Tufts University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Evaluations, run by Tufts University at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shibani Ghosh, PhD (6176363771, shibani.ghosh@tufts.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diet Diversity in Pregnant and Lactating women (time frame: 2024). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05365698, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.