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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02903602
Other study ID # FGGS-01
Secondary ID N° AID-OAA-A-10-
Status Completed
Phase N/A
First received August 31, 2016
Last updated September 15, 2016
Start date October 2010
Est. completion date September 2014

Study information

Verified date September 2016
Source Future Generations Graduate School
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the effectiveness of an innovative methodology for training Community Health Workers that will improve their effectiveness in educating mothers to adopt best practice health behaviors in the home.


Description:

Objective: Training of community health workers (CHW) is a growing priority to close the gap between health services and mothers/families in resource poor communities. To address research needs on how to improve effectiveness of CHW training, the investigators tested an innovative CHW teaching methodology called "Sharing Histories" hypothesizing that this would empower and enable CHW to better teach mothers to improve health knowledge and behaviors that contribute to improved child growth.

Method: The study was a cluster-randomized controlled trial: 22 health facility jurisdictions were matched and randomly assigned as experimental or control. Health personnel Tutors and female CHW were trained using either the "Sharing Histories" methodology (experimental) or a standard but still participatory teaching method (control). Training content, materials, and other interventions were held constant between study groups. Impact on maternal knowledge and practices, and child growth and morbidity were measured in representative household surveys at baseline, midterm, and final evaluation, with 600 mothers interviewed - 300 in each study group - at each point in time.


Recruitment information / eligibility

Status Completed
Enrollment 600
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 23 Months
Eligibility Inclusion Criteria:

- Adult interviewed must be mother or guardian of a child under two years of age.

- Child from birth (0.1 months-old) to under two years of age (23.9 months-old).

Exclusion Criteria:

- If a mother selected for interview had more than one child under age two years, only the younger child was considered for the interview and anthropometry measurements.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention


Intervention

Behavioral:
Sharing Histories training method for CHW
Female Community Health Worker training participants were led through a guided process of recalling and sharing their autobiographical memories of their personal experiences in the first 1000 days of each of their children (pregnancy, childbirth, postpartum, newborn, breastfeeding, complementary feeding, infant diarrhea and hygiene, pneumonia). On the basis of memories, cultural beliefs and practices are identified and training content is built.
Standard training method for CHW
Female Community Health Workers were trained with standard participatory teaching method with three phases: identify knowledge, provide new knowledge, evaluate learning.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Future Generations Graduate School Instituto de Investigacion Nutricional, Peru, United States Agency for International Development (USAID)

Outcome

Type Measure Description Time frame Safety issue
Primary Change in rate of stunting in children under two years of age (birth to 23.9 months of age) Stunting is defined as low height-for-age less than -2 z-scores from the median on the World Health Organization growth standard, 2006. Chidren born up to 24 months prior to the baseline survey in 2010. Children born up to 24 months prior to the final survey in 2014 No
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