Growth DisordersNCT03518593
Evaluation of NICHE Programme Activities in Kenya
A study testing Cash and counselling in people with Growth Disorders and Malnutrition, run by Kimetrica LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 23 monthsHealthy volunteers can take part
- Conditions the study is for
- Growth Disorders, Malnutrition
- What is being tested?
- Cash and counselling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 26 Jun 2018
- 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 Up to 23 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- not residing in CT-OVC households
About this study
Official title: 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.
- Conditions
- Growth Disorders, Malnutrition
- Being tested
- Cash and counselling
- Medical subject headings
- Growth Disorders, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cash and counsellingOther
Additional 500 Ksh per child per month and household visits by Community health Volunteers (CHVs)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Additional cash transfer and nutritional counselling Receives: Other: Cash and counselling |
| Control | No intervention | Existing cash transfer only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stunting
HAZ (height for age z score) < -2 SDs of WHO median
Measured: 8-15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start1 Jan 2017
- Primary completion26 Jun 2018 (estimated)
- Study completion26 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kimetrica LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- UNICEF, European Commission
- Responsible party
- Sponsor
- Investigators
- Helen Guyatt, PhD, Principal investigator, Kimetrica LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518593
- Sponsor's protocol ID
- UN-43203222
- Status last verified
- Apr 2018
- First submitted
- 25 Apr 2018
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of NICHE (Nutritional Improvements Through Cash and Health Education) Programme Activities in Kitui and Machakos, Kenya
- ClinicalTrials.gov ID
- NCT03518593
- Acronym / sponsor ID
- UN-43203222
- Conditions
- Growth Disorders, Malnutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Kimetrica LLCIndustry (pharma, biotech, devices)
- Collaborators
- UNICEF, European Commission
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 26 Jun 2018 (estimated)
- Study completion
- 26 Jun 2018 (estimated)
- First posted
- 8 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Cash and counsellingAdditional cash transfer and nutritional counselling |
| Control | No intervention | –Existing cash transfer only |
Who may qualify
- Ages
- Up to 23 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- not residing in CT-OVC households
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cash and counsellingAdditional 500 Ksh per child per month and household visits by Community health Volunteers (CHVs) | Other | Intervention |
Primary outcome
Stunting
Time frame: 8-15 months
HAZ (height for age z score) < -2 SDs of WHO median
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen Guyatt, PhD principal investigator
Kimetrica LLC
Questions about this trial
What is this clinical trial studying?
A study testing Cash and counselling in people with Growth Disorders and Malnutrition, run by Kimetrica LLC.
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 1 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: status not confirmed, as of the sponsor's last update on 8 May 2018. 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?
Results are not available in the source record.
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?
Stunting (time frame: 8-15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2018.