Effectiveness Study During the First 1,000 Days in Kenya

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03558464
Recruitment Status : Recruiting
First Posted : June 15, 2018
Last Update Posted : June 25, 2018
One Acre Fund
Information provided by (Responsible Party):
Fabian Rohner, GroundWork

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).

Condition or disease Intervention/treatment Phase
Stunting Anemia Micronutrient Deficiency Dietary Supplement: Intervention (integrated package) Other: Control Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster Randomized, Parallel-group, Prospective, Follow-up Effectiveness Study
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.
Primary Purpose: Prevention
Official Title: Programme Effectiveness of an Integrated Programme to Reduce Maternal and Child Malnutrition in Kenya: Cluster-randomized Controlled Trial in Pregnant Women and Their Offspring Comparing an Agricultural Intervention Alone to a Combined Agricultural, Nutrition and WASH Intervention
Actual Study Start Date : June 8, 2018
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

Arm Intervention/treatment
Experimental: Intervention

Intervention (agriculture-focused package

+ nutrition-sensitive and nutrition-specific interventions=integrated package)

Dietary Supplement: Intervention (integrated package)

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

  • LNS (Enov'Nutributter, 20g sachet daily)
  • ORS + zinc
  • Birds of chicken (to increase egg consumption)

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).

Active Comparator: Control
(agriculture-focused package)
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. 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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Maternal hemoglobin [ Time Frame: 8 months ]
    Change in haemoglobin concentration between 34 weeks gestation and 6 months post-partum

  2. Birth weight [ Time Frame: 7 months ]
    Differences in birth weight between intervention and control group

  3. Birth length [ Time Frame: 7 months ]
    Differences in birth length between intervention and control group

  4. Head circumference at birth [ Time Frame: 7 months ]
    Differences in head circumference between intervention and control group

  5. Child hemoglobin [ Time Frame: 2 years ]
    Change in hemoglobin concentration between at birth, 6 and 24 months of age

  6. Child iron deficiency [ Time Frame: 18 months ]
    Change in proportion with inflammation-adjusted iron deficiency between 6 and 24 months of age

  7. Child vitamin A deficiency [ Time Frame: 18 months ]
    Change in proportion with inflammation-adjusted vitamin A deficiency between 6 and 24 months of age

  8. Child diarrhea [ Time Frame: 18 months ]
    Diarrhea incidence rate between 6 and 24 months of age

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women will be enrolled (gender-specific) but for their offspring, inclusion is gender-independent
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03558464

Contact: Rita Wegmüller, PhD +41792720203
Contact: Fabian Rohner, PhD +84915136944

One Acre Fund Recruiting
Kakamega, Kenya
Contact: Kelvin Musau, MSc    +254711534867   
Principal Investigator: Kelvin Musau, MSc         
Sub-Investigator: Haley Kawaja, MSc         
Sub-Investigator: Marion Kiprotich, MSc         
Sponsors and Collaborators
Fabian Rohner
One Acre Fund
Principal Investigator: Rita Wegmüller, PhD GroundWork

Responsible Party: Fabian Rohner, President, GroundWork Identifier: NCT03558464     History of Changes
Other Study ID Numbers: GW_1AF_KenEff_1000d
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No