Back to resultsEvaluation of NICHE Programme Activities in Kenya
Primary Purpose
Growth Disorders, Malnutrition
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cash and counselling
Sponsored by
About this trial
This is an interventional other trial for Growth Disorders
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Additional cash transfer and nutritional counselling
Existing cash transfer only
Outcomes
Primary Outcome Measures
Stunting
HAZ (height for age z score) < -2 SDs of WHO median
Secondary Outcome Measures
Full Information
NCT ID
NCT03518593
First Posted
April 25, 2018
Last Updated
April 25, 2018
Sponsor
Kimetrica LLC
Collaborators
UNICEF, European Commission
1. Study Identification
Unique Protocol Identification Number
NCT03518593
Brief Title
Evaluation of NICHE Programme Activities in Kenya
Official Title
Evaluation of NICHE (Nutritional Improvements Through Cash and Health Education) Programme Activities in Kitui and Machakos, Kenya
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
June 26, 2018 (Anticipated)
Study Completion Date
June 26, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kimetrica LLC
Collaborators
UNICEF, European Commission
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth Disorders, Malnutrition
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Additional cash transfer and nutritional counselling
Arm Title
Control
Arm Type
No Intervention
Arm Description
Existing cash transfer only
Intervention Type
Other
Intervention Name(s)
Cash and counselling
Intervention Description
Additional 500 Ksh per child per month and household visits by Community health Volunteers (CHVs)
Primary Outcome Measure Information:
Title
Stunting
Description
HAZ (height for age z score) < -2 SDs of WHO median
Time Frame
8-15 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
23 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Guyatt, PhD
Organizational Affiliation
Kimetrica LLC
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Evaluation of NICHE Programme Activities in Kenya
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