NCT05365698

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,145

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 3, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 9, 2022

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

4.1 years

First QC Date

April 25, 2022

Last Update Submit

November 21, 2023

Conditions

Outcome Measures

Primary Outcomes (6)

  • Diet Diversity in Pregnant and Lactating women

    Percentage of pregnant and lactating women meeting the minimum dietary diversity for women metric (MDDW)

    2024

  • Early initiation of breastfeeding

    Percentage of women who initiate breastfeeding within the first hour of birth

    2024

  • Exclusive breastfeeding

    Percentage of women who exclusively breastfeed their infants from birth to 6 months of age

    2024

  • Median duration of exclusive breastfeeding

    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

    Percentage of children aged 6-23 months achieving a minimum acceptable diet (MAD)

    2021

  • Improved post party family planning

    Percentage of women using modern contraceptive improved postpartum practice on the use of modern contraceptive methods

    2024

Study Arms (2)

Cohort I

randomly assigned 12 health facilities (treatment/intervention group) that will have access to CHN program components

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

Behavioral: Community Health and Nutrition Program

Interventions

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 ICohort II

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant and Lactating Women with child under 2 years Not willing to participate or provide informed consent Not living in the study area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mindset

Amman, Jordan

RECRUITING

MeSH Terms

Interventions

Public Health

Intervention Hierarchy (Ancestors)

HealthPopulation CharacteristicsEnvironment and Public Health

Study Officials

  • Shibani Ghosh, PhD

    Tufts University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shibani Ghosh, PhD

CONTACT

Robin Shrestha, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate Professor

Study Record Dates

First Submitted

April 25, 2022

First Posted

May 9, 2022

Study Start

October 3, 2021

Primary Completion

October 30, 2025

Study Completion

October 30, 2025

Last Updated

November 22, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
publicly accessible in 2027-28
Access Criteria
Anyone who wishes to have access to the de-identified dataset for any research purpose will have access to the data. Data will be publicly available in the United States Agency for International Development's (USAID) Development Data Library (DDL), and Tufts Research Data Management platform.URLs will be added later once the data is successfully uploaded and data-sharing URLs have been generated.

Locations