Infant Nutrition DisordersNCT02903602
Sharing Histories: Test of a Teaching Method for Community Health Workers
A study testing Sharing Histories training method for CHW and Standard training method for CHW in people with Infant Nutrition Disorders and Health Behavior, run by Future Generations Graduate School.
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. Read more about this study
- Who is it for?
- Ages Up to 23 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant Nutrition Disorders, Health Behavior
- What is being tested?
- Sharing Histories training method for CHW and Standard training method for CHW
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to Sep 2014
- Phase
- Interventional
- 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 Up to 23 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
About this study
Official title: Health in the Hands of Women: Test of a Community Health Worker Teaching Method "Sharing Histories"
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.
Read the detailed 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.
- Conditions
- Infant Nutrition Disorders, Health Behavior
- Being tested
- Sharing Histories training method for CHW, Standard training method for CHW
- Keywords
- sharing histories, autobiographical memory, health behavior, narrative communication, community health workers, global health, maternal and child health, stunting
- Medical subject headings
- Infant Nutrition Disorders, Health Behavior, Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sharing Histories training method for CHWBehavioural
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 CHWBehavioural
Female Community Health Workers were trained with standard participatory teaching method with three phases: identify knowledge, provide new knowledge, evaluate learning.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard training method for CHW |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startOct 2010
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant Nutrition DisordersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future Generations Graduate School
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Instituto de Investigacion Nutricional, Peru
- Responsible party
- Principal investigator, Laura C. Altobelli, Future Generations Graduate School
- Investigators
- Laura C. Altobelli, DrPH, Principal investigator, Future Generations Graduate School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02903602
- Sponsor's protocol ID
- FGGS-01
- Other IDs
- N° AID-OAA-A-10-00048
- Status last verified
- Sep 2016
- First submitted
- 31 Aug 2016
- Last updated
- 16 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data set available to researchers by contacting Principal Investigator
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health in the Hands of Women: Test of a Community Health Worker Teaching Method "Sharing Histories"
- ClinicalTrials.gov ID
- NCT02903602
- Acronym / sponsor ID
- FGGS-01
- Conditions
- Infant Nutrition Disorders, Health Behavior
- Keywords
- sharing histories, autobiographical memory, health behavior, narrative communication, community health workers, global health, maternal and child health, stunting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Future Generations Graduate SchoolUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Instituto de Investigacion Nutricional, Peru
- Study start
- Oct 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 16 Sep 2016 (estimated)
- 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 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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHW training method-Sharing Histories | Experimental | Behavioral: Sharing Histories training method for CHWExperimental 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. |
| CHW training method-Standard | Active comparator | Behavioral: Standard training method for CHWControl 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. |
Who may qualify
- Ages
- Up to 23 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Sharing Histories training method for CHWFemale 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. | Behavioural | CHW training method-Sharing Histories |
| Standard training method for CHWFemale Community Health Workers were trained with standard participatory teaching method with three phases: identify knowledge, provide new knowledge, evaluate learning. | Behavioural | CHW training method-Standard |
Primary outcome
Change in rate of stunting in children under two years of age (birth to 23.9 months of age)
Time frame: 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
Stunting is defined as low height-for-age less than -2 z-scores from the median on the World Health Organization growth standard, 2006.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2016.
- Individual participant dataSharing planned: Yes. Data set available to researchers by contacting Principal Investigator
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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.
Laura C. Altobelli, DrPH principal investigator
Future Generations Graduate School
Questions about this trial
What is this clinical trial studying?
A study testing Sharing Histories training method for CHW and Standard training method for CHW in people with Infant Nutrition Disorders and Health Behavior, run by Future Generations Graduate School.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 16 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in rate of stunting in children under two years of age (birth to 23.9 months of age) (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2016.