Evaluation of NICHE Programme Activities in Kenya
Sponsor
Kimetrica LLC (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03518593
Collaborator
UNICEF (Other), European Commission (Other)
800
2
17.8
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
800 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Evaluation of NICHE (Nutritional Improvements Through Cash and Health Education) Programme Activities in Kitui and Machakos, Kenya
Actual Study Start Date
:
Jan 1, 2017
Anticipated Primary Completion Date
:
Jun 26, 2018
Anticipated Study Completion Date
:
Jun 26, 2018
Arms and Interventions
| 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 |
Outcome Measures
Primary Outcome Measures
- Stunting [8-15 months]
HAZ (height for age z score) < -2 SDs of WHO median
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
to 23 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Kimetrica LLC
- UNICEF
- European Commission
Investigators
- Principal Investigator: Helen Guyatt, PhD, Kimetrica LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Kimetrica LLC
ClinicalTrials.gov Identifier:
NCT03518593
Other Study ID Numbers:
- UN-43203222
First Posted:
May 8, 2018
Last Update Posted:
May 8, 2018
Last Verified:
Apr 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: