Effectiveness of an Integrated Programme to Reduce Maternal and Child Malnutrition in Kenya: a Study in Pregnant Women and Their Offspring
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,199
- Locations
- 1
- Primary Endpoint
- Stunting and length/height-for-age z-score
Study Overview
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).
Detailed Description
Background/Introduction
In partnership with the Children's Investment Fund Foundation (CIFF), 1AF aims to introduce nutrition-sensitive and nutrition-specific components into the services offered to smallholder farmer households. The nutrition-specific interventions consist of providing LNS to pregnant women up to 6 months after delivery and LNS to their offspring from 6-24 months of age. These nutritional supplements are recommended by WHO in areas where micronutrient deficiencies and malnutrition are prevalent. As a nutrition-sensitive intervention, pregnant women will receive mebendazole as preventive anthelminthic treatment after the first trimester.
In order to increase protein consumption, chicken birds will be provided to households. Further, children older than 6 months will be provided with oral rehydration salts (ORS) and zinc supplements as recommended by WHO and UNICEF for the treatment of acute diarrhoea [9]. Lastly, some WASH related interventions will also be provided, such as training sessions, soap for hand washing and chlorine for drinking water treatment.
To test the incorporation of nutrition services in 1AF's agricultural programme, pilot projects in western Kenya will be conducted between 2017 and 2020.
The dietary diversity, food frequency and subsequently, a minimum acceptably dietary quality for young children are lower in the Western Province than for the national average.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Pregnant women (≥ 18 years of age) with gestational age ≤20 weeks
- •Written Informed Consent as documented by signature
Exclusion Criteria
- •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
Arms & Interventions
Intervention
Intervention (agriculture-focused package
+ nutrition-sensitive and nutrition-specific interventions=integrated package)
Intervention: Intervention (integrated package) (Dietary Supplement)
Control
(agriculture-focused package)
Intervention: Control (Other)
Outcomes
Primary Outcomes
Stunting and length/height-for-age z-score
Time Frame: 2 years
Change in length-for-age z-score (LAZ) between birth and 24 months of age
Length-for-age z-score at 24 months of age
Time Frame: 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.
Stunting and length/height-for-age z-score
Time Frame: 2 years
Change in length-for-age z-score (LAZ) between birth and 24 months of age
Length-for-age z-score at 24 months of age
Time Frame: 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.
Secondary Outcomes
- Maternal hemoglobin(8 months)
- Birth weight(7 months)
- Birth length(7 months)
- Head circumference at birth(7 months)
- Child hemoglobin(2 years)
- Child iron deficiency(18 months)
- Child vitamin A deficiency(18 months)
- Child diarrhea(18 months)
- Proportion of stunted children (length-for-age z-score <-2 SD) at 6 and 24 months of age(At 6 months and 24 months of age)
- Inflammation adjusted serum ferritin concentration at 6 and 24 months of age(At 6 and 24 months of age)
- Retinol-binding protein at 6 and 24 months of age(At 6 and 24 months of age)
- Child hemoglobin(2 years)
- Child iron deficiency(18 months)
- Maternal hemoglobin(8 months)
- Birth weight(7 months)
- Birth length(7 months)
- Head circumference at birth(7 months)
- Child vitamin A deficiency(18 months)
- Child diarrhea(18 months)
- Length-for-age z-score at birth and 6 months of age(At birth and 6 months of age)
- Proportion of stunted children (length-for-age z-score <-2 SD) at 6 and 24 months of age(At 6 months and 24 months of age)
- Inflammation adjusted serum ferritin concentration at 6 and 24 months of age(At 6 and 24 months of age)
- Retinol-binding protein at 6 and 24 months of age(At 6 and 24 months of age)
Investigators
Fabian Rohner
President
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