Cluster Randomized, Parallel-group, Prospective, Follow-up Effectiveness Study in Kenyan Children 6-35 Months

NCT03448484 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1927

Last updated 2021-07-28

No results posted yet for this study

Summary

Malnutrition is a public health problem in Kenya, with 26% of children under-five years of age stunted, and 26% of pre-school children, 26% of women of reproductive age and 42% of pregnant women being anaemic, respectively. Agriculture is the main source of income, food and nutrients for the majority of rural families in Sub-Saharan Africa including Kenya. Most farmers are smallholders and are vulnerable to poor nutrition. Thus far, programmes have mostly focused on increasing yields and household income, but not on improving nutritional status. One Acre Fund (1AF) has over the past 10 years successfully introduced an agriculture programme to smallholder farmers in Western Kenya focusing on improving harvest. 1AF is therefore well placed to transform an existing and successful agriculture programme into the world's largest 'nutrition network' for farmers, and it is the hope that a partnership between Children's Investment Fund Foundation (CIFF) and 1AF will create a strong voice for nutrition within the agriculture sector. The project aims to use an integrated programme by introducing nutrition-sensitive (improved water, sanitation and hygiene (WASH): e.g. soap for hand washing) and nutrition-specific (e.g. micronutrient supplements) components to 1AF's agricultural programme.

The impact of such an integrated programme will be assessed in a cluster-randomized intervention study in children 6-35 months at recruitment comparing one group receiving the integrated intervention to another group receiving the agricultural intervention (already in place).

Conditions

  • Stunting

Interventions

DIETARY_SUPPLEMENT

Intervention (integrated package)

Provided to all intervention households: * Soap (for daily hand washing) * Chlorine solution (for daily drinking water treatment) * 8 birds of chicken (child consumes 1 egg/day) * Vegetable seeds (red onion, indigenous managu and sukuma) * Monthly trainings to all farmers on nutrition and WASH * Micronutrient powder (MixMe, 1g sachet every third day) * Oral rehydration solution (ORS) + zinc (to be used to treat acute diarrhoea: 20 mg zinc tablets; ORS sachets (10.3 g/sachet)) All families in the intervention group will receive the same agriculture-focused package (see section 'control intervention' below) as those in the control group.

OTHER

Control

Active control: The families living in the control clusters will receive the agriculture-focused package that is already in place in all participating clusters through the 1AF programme. The control intervention is the same for study 1 and study 2. This agriculture-focused package consists of: * Agricultural training (every 2 weeks on average) for all * Free to enrol for the following products on credit: * Compost boosters * Cook stoves * Seeds (onions, maize, indigenous greens, beans) * Maize storage bags * Drying tarps * Trees * Solar lights * Fertilizer * Actellic dust (insecticide) * Re-usable sanitary pads

Sponsors & Collaborators

  • One Acre Fund

    collaborator UNKNOWN
  • Children's Investment Fund Foundation

    collaborator OTHER
  • Fabian Rohner

    lead OTHER

Principal Investigators

  • Rita Wegmüller · GroundWork

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
35 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-12
Primary Completion
2020-07-01
Completion
2020-10-01

Countries

  • Kenya

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03448484 on ClinicalTrials.gov