NCT02903602

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2010

Longer than P75 for not_applicable

Status
completed

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 1, 2010

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 16, 2016

Completed
Last Updated

September 16, 2016

Status Verified

September 1, 2016

Enrollment Period

3.9 years

First QC Date

August 31, 2016

Last Update Submit

September 15, 2016

Conditions

Keywords

sharing historiesautobiographical memoryhealth behaviornarrative communicationcommunity health workersglobal healthmaternal and child healthstunting

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

CHW training method-Sharing Histories

EXPERIMENTAL

Experimental clusters of primary health care facilities provided training to Community Health Workers (CHW) from their communities utilizing the experimental teaching methodology, "Sharing Histories". CHW in both study groups made home visits to pregnant women and mothers of children under two years of age to teach mothers, monitor behaviors and danger signs in pregnant women, newborns, and children, and refer cases when needed for preventive and curative care.

Behavioral: Sharing Histories training method for CHW

CHW training method-Standard

ACTIVE COMPARATOR

Control clusters of primary health care facilities provided training to Community Health Workers (CHW) from their communities utilizing a standard CHW teaching methodology. CHW in both study groups made home visits to pregnant women and mothers of children under two years of age to teach mothers, monitor behaviors and danger signs in pregnant women, newborns, and children, and refer cases when needed for preventive and curative care.

Behavioral: Standard training method for CHW

Interventions

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.

CHW training method-Sharing Histories

Female Community Health Workers were trained with standard participatory teaching method with three phases: identify knowledge, provide new knowledge, evaluate learning.

CHW training method-Standard

Eligibility Criteria

AgeUp to 23 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infant Nutrition DisordersHealth BehaviorGrowth Disorders

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesBehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Laura C. Altobelli, DrPH

    Future Generations Graduate School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor - Principal Investigator

Study Record Dates

First Submitted

August 31, 2016

First Posted

September 16, 2016

Study Start

October 1, 2010

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

September 16, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will share

Data set available to researchers by contacting Principal Investigator