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CompletedNCT03176914Updated Apr 1, 2019

Testing the Effectiveness of a Modified Community Model in Improving Child Health Outcomes in Mashonaland East, Zimbabwe

An interventional study of prevention and management of childhood illnesses at community level and conventional community interventions in Pneumonia, Diarrhea and Malnutrition, sponsored by University of Zimbabwe. Completed at 1 site in Zimbabwe. Open to female participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-01.

Sponsored by University of Zimbabwe · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jan 2017, registered May 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
765
Allocation
Randomized
Ages
18 Years to 49 Years
Sex
Female
01

Study summary

This study modified and contextualized a community mobilization approach in a bid to find a solution to reduce the high incidence and prevalence of child morbidity and mortality in Zimbabwe.The developed model will be tested for its effectiveness in reducing child morbidity and mortality at community level by comparing the effect of the intervention to that of the conventional community interventions.

Read the detailed description

In Zimbabwe the Neonatal and infant mortality rate are 31/1000 and 57/1000 respectively (ZDHS, 2011). Seventy -four percent of these death occur at community level due to the delay in deciding to seek care . The government of Zimbabwe has intensified facility based health systems though very little has been done in community health system strengthening yet there is glaring evidence from recent studies that the burden of infant and child morbidity and mortality is largely at community level. The effect of social mobilization approaches in reducing socio-cultural causes of morbidity and mortality is not known. Evidence base for participatory models and their effectiveness remains scanty and in-country, there is no approved , integrated community mobilization model that achieves saturation coverage in addressing all facets of community maternal newborn and child health along the continuum of care. Community immersion with health services is in line with the Alma Ata Declaration of the Primary Health Care approach that seeks to decentralize health services to the marginalized people. The study will test the effectiveness of the contextualized model in improving child health outcomes.

A cluster randomized controlled design will be used in 2 randomly selected districts of Mashonaland East , Zimbabwe. Women 18- 49 years with children 0-48 months in the selected districts will be recruited and followed up for 9-12 months . Stratified randomization will be used to select 11 pairs of participating villages . Central randomization will be employed for allocation concealment . The sample size was calculated in STATA 13. assuming a morbidity prevalence of 50% with a margin error of 5%. The assumed intra-cluster correlation coefficient (ICC) of 0.05 with a level of significance of 5% , design effect of 2.45 and power of 0.9. The sample size per arm will be 330 mother-child pairs and each arm will have 11 clusters.

Data will be collected monthly using monthly data collection tools. The study will require participants to commit at most 2 hours once in every two weeks. The main intervention is provision of critical health education and targeted promotion services to the participants in their locality. Participatory approaches will be employed in the intervention arm for learning and sharing of good community IMNCI practices for the prevention and management of childhood illnesses. Participants will be motivated through learning exchange visits and provision of promotional materials as incentives for successful completion and practice of recommended behaviors and child care practices.

02

Conditions studied

  • Pneumonia
  • Diarrhea
  • Malnutrition
  • Fever

Keywords

  • Community mobilisation
03

In context

Malnutrition

1,588 studies on the registry are indexed under Malnutrition; 237 are open to participants now.

This study's enrollment of 765 is above the median of 90 across 1,135 interventional studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

University of Zimbabwe is the lead sponsor of 18 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

Pregnant and lactating women staying in the study area with children below 4 years

Exclusion criteria

Exclusion Criteria:

  1. Women of child bearing age who do not dwell permanently in the study area
  2. Women who are very ill and mentally challenged
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
765 participants (actual)

Study arms

  • Experimental
    Intervention arm

    Eleven clusters (Villages) will be randomly selected. A cluster will comprises of 10-15 volunteers selected from a cohort 10-15 households. Educative sessions will be held in each cluster once every fortnight using a participatory methods by a trained Village Health Worker (VHW). A session will focus on one thematic area running for 1-2 hours. Trained volunteers will in turn replicate the session(s) in their cohorts and do home visits to monitor care practices and screen children for various ailment. Health information is collated from each cluster and consolidated by the VHW who reports monthly at the clinic.

    Behavioral: prevention and management of childhood illnesses at community level

  • Active comparator
    Conventional Intervention arm

    In the conventional mobilization system, a Village Health Worker facilitates community health programs as the sole source of health education for the entire villages. She does home visits, child growth monitoring and the various components primary health care at village level inclusive of disease surveillance and community case management using the 'supermarket approach' , whereby 3 or more themes are covered in a space of 10- 30 minutes in functions like funerals, village gatherings and other opportune moments. The Village Health worker prepares village monthly reports on all the indicators on community health and submits to the local health centre.

    Behavioral: conventional community interventions

Interventions

  • Behavioralprevention and management of childhood illnesses at community level

    provision of critical health education and targeted promotion services to the participants in their locality

  • Behavioralconventional community interventions

    community health programs as the sole source of health education

06

What researchers measure

Primary outcomes

  1. Reduction in child morbidity

    Incidence of childhood illnesses

    Time frame: 9- 12 months

Secondary outcomes

  1. Early ANC uptake

    Number of women who booked in the first trimester

    Time frame: 3 Months

  2. Institutional deliveries

    Proportion of women with children 0-48 months who delivered at a health facility

    Time frame: 3 months

  3. Postnatal care uptake

    Proportion of women with a child 0 -48 months who received post-natal care in their last delivery

    Time frame: 3 months

  4. Knowledge levels on child care

    Proportion of women with a child 0-48 months who have basic knowledge on dangers signs and management of childhood illnesses

    Time frame: 3 months

07

Study locations

1 site
  • College of Health Sciences
    Harare, 00263, Zimbabwe
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03176914
Lead sponsor
University of Zimbabwe
Collaborators
NORHED
Responsible party
Maxwell Mhlanga (Principal Investigator, University of Zimbabwe) — Principal investigator
First posted
Jun 6, 2017
Start date
Jan 19, 2017
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018
Last update
Apr 1, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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