Evaluation of NICHE Programme Activities in Kenya

April 25, 2018 updated by: Kimetrica LLC

Evaluation of NICHE (Nutritional Improvements Through Cash and Health Education) Programme Activities in Kitui and Machakos, Kenya

This study evaluates the impact of additional cash and nutritional counselling on nutrition outcomes in pregnant women and children up to the age of two years in CT-OVC (cash transfer- orphan and vulnerable children) households in Kitui and Machakos counties of Kenya. The control arm households will receive their normal CT-OVC cash payment and the intervention arm will receive an additional cash payment and nutritional counselling.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

800

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pregnant women and children aged up to 23 months of age in households receiving CT-OVC cash transfers in Kitui and Machakos counties of Kenya

Exclusion Criteria:

  • not residing in CT-OVC households

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Additional cash transfer and nutritional counselling
Other: Cash and counselling
Additional 500 Ksh per child per month and household visits by Community health Volunteers (CHVs)
No Intervention: Control
Existing cash transfer only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stunting
Time Frame: 8-15 months
HAZ (height for age z score) < -2 SDs of WHO median
8-15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kimetrica LLC

Collaborators

European Commission
UNICEF

Investigators

  • Principal Investigator: Helen Guyatt, PhD, Kimetrica LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Anticipated)

June 26, 2018

Study Completion (Anticipated)

June 26, 2018

Study Registration Dates

First Submitted

April 25, 2018

First Submitted That Met QC Criteria

April 25, 2018

First Posted (Actual)

May 8, 2018

Study Record Updates

Last Update Posted (Actual)

May 8, 2018

Last Update Submitted That Met QC Criteria

April 25, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UN-43203222

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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