Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05365698
Other study ID # 00001816
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 3, 2021
Est. completion date October 30, 2025

Study information

Verified date November 2023
Source Tufts University
Contact Shibani Ghosh, PhD
Phone 6176363771
Email shibani.ghosh@tufts.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1145
Est. completion date October 30, 2025
Est. primary completion date October 30, 2025
Accepts healthy volunteers
Gender Female
Age group 18 Years to 49 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Community Health and Nutrition Program
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.

Locations

Country Name City State
Jordan Mindset Amman

Sponsors (1)

Lead Sponsor Collaborator
Tufts University

Country where clinical trial is conducted

Jordan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diet Diversity in Pregnant and Lactating women Percentage of pregnant and lactating women meeting the minimum dietary diversity for women metric (MDDW) 2024
Primary Early initiation of breastfeeding Percentage of women who initiate breastfeeding within the first hour of birth 2024
Primary Exclusive breastfeeding Percentage of women who exclusively breastfeed their infants from birth to 6 months of age 2024
Primary Median duration of exclusive breastfeeding Increased median duration of exclusive breastfeeding (months) in infants aged 0-6 months 2024
Primary 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) 2021
Primary Improved post party family planning Percentage of women using modern contraceptive improved postpartum practice on the use of modern contraceptive methods 2024
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03964311 - Risk for Short-term Adverse Events in Older Emergency Department Users N/A
Recruiting NCT05381233 - Quality of Life and Functional Performance in Children With Spastic Cerebral Palsy N/A
Completed NCT03286660 - 3 Minutes Chair Rise Test (3CRT) in Patients With COPD N/A
Completed NCT03734042 - PRP Intrauterine Infusion in Thawed Embryo Cycles Phase 4