NCT03518593

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 8, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2018

Completed
Last Updated

May 8, 2018

Status Verified

April 1, 2018

Enrollment Period

1.5 years

First QC Date

April 25, 2018

Last Update Submit

April 25, 2018

Conditions

Growth DisordersMalnutrition

Outcome Measures

Primary Outcomes (1)

  • Stunting

    HAZ (height for age z score) \< -2 SDs of WHO median

    8-15 months

Study Arms (2)

Intervention

EXPERIMENTAL

Additional cash transfer and nutritional counselling

Other: Cash and counselling

Control

NO INTERVENTION

Existing cash transfer only

Interventions

Cash and counsellingOTHER

Additional 500 Ksh per child per month and household visits by Community health Volunteers (CHVs)

Intervention

Eligibility Criteria

AgeUp to 23 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • not residing in CT-OVC households

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Growth DisordersMalnutrition

Interventions

CASP8 and FADD-Like Apoptosis Regulating ProteinCounseling

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Death Domain Receptor Signaling Adaptor ProteinsAdaptor Proteins, Signal TransducingIntracellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsTumor Necrosis Factor Receptor-Associated Peptides and ProteinsApoptosis Regulatory ProteinsCarrier ProteinsProteinsMental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Helen Guyatt, PhD

    Kimetrica LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2018

First Posted

May 8, 2018

Study Start

January 1, 2017

Primary Completion

June 26, 2018

Study Completion

June 26, 2018

Last Updated

May 8, 2018

Record last verified: 2018-04