Effectiveness Study During the First 1,000 Days in Kenya

NCT03558464 | Completed DMC

• 1 other identifier: GW_1AF_KenEff_1000d
• Study Type: interventional
• Target: 1,199
• Locations: 1 country
• Sites: 1

Brief Summary

Malnutrition is a public health problem in Kenya, with 26% of children underfive 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 nutritionspecific (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 pregnant women and - after delivery - their offspring until they reach two years of age comparing one group receiving the integrated intervention to another group receiving the agricultural intervention (already in place).

Conditions

Stunting; Anemia; Micronutrient Deficiency

Outcome Measures

Primary Outcomes (2)

• Stunting and length/height-for-age z-score

  Change in length-for-age z-score (LAZ) between birth and 24 months of age

  2 years

• Length-for-age z-score at 24 months of age

  Update (October 2025): The outcome "Length-for-age z-score (LAZ) at 24 months of age" has been added to this record to correct an omission in the original registration. The trial's sample size calculation was based on this outcome (LAZ at 24 months), which was pre-specified as an outcome in the statistical analysis plan finalized before data analysis. The originally registered primary outcome, "change in LAZ between birth and 24 months," remains listed and is reported in the corresponding publication. This update represents a correction of a documentation error and does not constitute a post hoc change to the trial analysis. The length-for-age z-score (LAZ) is calculated using the WHO Child Growth Standards. It represents the number of standard deviations a child's length is from the median of healthy reference children of the same age and sex. Higher LAZ values indicate better linear growth. Typical biological ranges fall approximately between -6 and +6.

  24 months of age

Secondary Outcomes (12)

• Maternal hemoglobin

  8 months

• Birth weight

  7 months

• Birth length

  7 months

• Head circumference at birth

  7 months

• Child hemoglobin

  2 years

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention (agriculture-focused package \+ nutrition-sensitive and nutrition-specific interventions=integrated package)

Dietary Supplement: Intervention (integrated package)

Control

ACTIVE COMPARATOR

(agriculture-focused package)

Other: Control

Interventions

Intervention (integrated package) DIETARY_SUPPLEMENT

During whole study (pregnant women and offspring): * Soap (for daily hand washing) * Chlorine solution (for daily drinking water treatment) * Life stage-appropriate (pregnancy, lactation, IYCF) monthly nutrition and WASH trainings During pregnancy and up to when offspring turns 6 months old: * LNS (Enov' Mum, 20g sachet daily) * Anthelminthic treatment (single-dose mebendazole (500mg), once during second trimester of pregnancy) Children 6-24 months of age * MNP (MixMe, 1g sachet every three days) * ORS + zinc * 1 egg per day All families in the intervention group will receive the same agriculture-focused package (see section 'control intervention' below) as those in the control group. All women will follow regular antenatal care as provided by the Kenyan government as part of their routine health system (e.g. intermittent preventive malaria treatment and iron-folic acid-supplements).

Intervention

Control OTHER

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. This agriculture focused package consists of: - Agricultural training (every 2 weeks on average) for all - Free to enrol for the following products on credit: o Compost boosters * Cook stoves o Seeds (onions, maize, indigenous greens, beans) o Maize storage bags o Drying tarps * Trees o Solar lights o Fertilizer o Actellic dust (insecticide) o Re-usable sanitary pads

Control

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Pregnant women will be enrolled (gender-specific) but for their offspring, inclusion is gender-independent
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women (≥ 18 years of age) with gestational age ≤20 weeks
• Written Informed Consent as documented by signature

You may not qualify if:

• Family does not intend to stay within the study area for at least the following 30 months
• Known history of allergy towards peanut or milk products
• Visible severe disease

Sponsors & Collaborators

• Fabian Rohner: lead
• One Acre Fund: collaborator
• Children's Investment Fund Foundation: collaborator

Study Sites (1)

One Acre Fund

Kakamega, Kenya

Location

MeSH Terms

Conditions

Growth Disorders; Anemia

Interventions

Methods

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Rita Wegmüller, PhD

  GroundWork

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The nature of the intervention package compared to the control package prevents a double-blind study design and thus, only the outcome assessors (data collectors) and the study statistician can be blinded to the group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: President

Model Details: Cluster Randomized, Parallel-group, Prospective, Follow-up Effectiveness Study

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: June 15, 2018
• Study Start: June 8, 2018
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: November 20, 2025

Record last verified: 2025-11

Locations

KE (1)