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Pregnancy RelatedNCT03188250

Chama Cha MamaToto: a Pilot Study of Peer Support Groups in Kenya

A study testing Chama cha Mamtoto in people with Pregnancy Related and Group, Peer, run by Moi University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Preventing maternal and newborn deaths remain high on the global agenda. To address this, the Academic Model Providing Access to Healthcare (AMPATH), in partnership with the Government of Kenya, launched Chama cha MamaToto, a community-led peer-support model that groups women together in pregnancy and infancy. Read more about this study

Who is it for?
Ages 15 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy Related, Group, Peer
What is being tested?
Chama cha Mamtoto
Could I receive a placebo?
No, everyone receives an active treatment
How many people
515 participants
Where
No sites listed yet
Study dates
Sep 2012to Jun 2016
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 15 to 70 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Pregnant women in communities where chamas were taking place
  • Any woman attending chama

Who cannot join

  • -

About this study

Official title: Increasing Pregnancy Health Services Uptake Through Integrated Peer Support Groups in Kenya: A Prospective Cohort Study

Preventing maternal and newborn deaths remain high on the global agenda. To address this, the Academic Model Providing Access to Healthcare (AMPATH), in partnership with the Government of Kenya, launched Chama cha MamaToto, a community-led peer-support model that groups women together in pregnancy and infancy. Central to the chama approach is the integration of health, social and financial literacy education with a savings/loans program.

Read the detailed description

To evaluate the feasibility of chamas, we analysed group attendance rates, GISE participation, membership retention, and continuation of the groups beyond the one year. To evaluate the effect of chamas, the investigators compared data from a prospective cohort of women in chamas with a group of controls who did not belong to a chama, matched for age, parity, and location of prenatal care. To evaluate the acceptability of chamas, FGDs were carried out with chama and non-chama participants, health providers and community health workers.

Being tested
Chama cha Mamtoto

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chama cha MamtotoBehavioural

    Chama cha Mamatoto is a community-based model of peer support group in pregnancy and infancy that combines health education, relationship building and a savings and loans program, led by community health workers

Study groups in NCT03188250
Study groupRoleWhat they receive
Chama cha MamaTotoExperimentalPregnant women in communities where chama cha mamatoto is taking place will be invited to join and participate in bi-weekly group meetings for a year
Receives: Behavioral: Chama cha Mamtoto
ReferentNo interventionPregnant women attending at least one prenatal visit in communities where chama cha mamatoto was implemented three months later served as the comparison

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Facility delivery

    Proportion of women giving birth in a health facility based on questionnaire

    Measured: 22 months

Secondary outcomes (3)

  1. 4 ANC visits

    attendance at 4 or more ANC visits in pregnancy based on questionnaire

    Measured: 22 months

  2. CHV homevisit

    CHW homevisit within 48 hours of birth based on questionnaire

    Measured: 22 months

  3. Exclusive breastfeeding

    Initiation of solids to the infant after 6 months based on questionnaire

    Measured: 22 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2017
  2. Study startSep 2012
  3. Primary completionJun 2014
  4. Study completionJun 2016

Resources

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
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
515 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03188250
Sponsor's protocol ID
UMoi3
Status last verified
Jun 2017
First submitted
31 May 2017
Last updated
15 Jun 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Maldonado LY, Songok JJ, Snelgrove JW, Ochieng CB, Chelagat S, Ikemeri JE, Okwanyi MA, Cole DC, Ruhl LJ, Christoffersen-Deb A. Promoting positive maternal, newborn, and child health behaviors through a group-based health education and microfinance program: a prospective matched cohort study in western Kenya. BMC Pregnancy Childbirth. 2020 May 12;20(1):288. doi: 10.1186/s12884-020-02978-w.

    PubMed 32398156

Questions about this trial

What is this clinical trial studying?

A study testing Chama cha Mamtoto in people with Pregnancy Related and Group, Peer, run by Moi University.

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 15 Jun 2017. 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?

Facility delivery (time frame: 22 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03188250, which also lists 1 linked publication.

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 15 Jun 2017.

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