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

NCT03448484 | Completed DMC

• 1 other identifier: GW_1AF_KenEff_U5
• Study Type: interventional
• Target: 1,927
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

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

  Change in length-for-age z-score (LAZ) over the course of the two years programme activity

  2 years

Secondary Outcomes (4)

• Nutrient density

  2 years

• Dietary diversity

  2 years

• Breastfeeding

  2 years

• WASH behaviour

  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

OTHER

Control (agriculture-focused package)

Other: Control

Interventions

Intervention (integrated package) DIETARY_SUPPLEMENT

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.

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. 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

Control

Eligibility Criteria

• Age: 6 Months - 35 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children 6-35 months of age at recruitment
• Caregiver providing written informed consent to participate

You may not qualify if:

• Family does not intend to stay within the study area for at least the following 24 months
• 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

Related Publications (4)

• Adu-Afarwuah S, Lartey A, Okronipa H, Ashorn P, Peerson JM, Arimond M, Ashorn U, Zeilani M, Vosti S, Dewey KG. Small-quantity, lipid-based nutrient supplements provided to women during pregnancy and 6 mo postpartum and to their infants from 6 mo of age increase the mean attained length of 18-mo-old children in semi-urban Ghana: a randomized controlled trial. Am J Clin Nutr. 2016 Sep;104(3):797-808. doi: 10.3945/ajcn.116.134692. Epub 2016 Aug 17.

  PMID: 27534634 BACKGROUND

• Ashorn P, Alho L, Ashorn U, Cheung YB, Dewey KG, Gondwe A, Harjunmaa U, Lartey A, Phiri N, Phiri TE, Vosti SA, Zeilani M, Maleta K. Supplementation of Maternal Diets during Pregnancy and for 6 Months Postpartum and Infant Diets Thereafter with Small-Quantity Lipid-Based Nutrient Supplements Does Not Promote Child Growth by 18 Months of Age in Rural Malawi: A Randomized Controlled Trial. J Nutr. 2015 Jun;145(6):1345-53. doi: 10.3945/jn.114.207225. Epub 2015 Apr 29.

  PMID: 25926413 BACKGROUND

• Matias SL, Mridha MK, Tofail F, Arnold CD, Khan MS, Siddiqui Z, Ullah MB, Dewey KG. Home fortification during the first 1000 d improves child development in Bangladesh: a cluster-randomized effectiveness trial. Am J Clin Nutr. 2017 Apr;105(4):958-969. doi: 10.3945/ajcn.116.150318. Epub 2017 Mar 8.

  PMID: 28275128 BACKGROUND

• Wegmuller R, Musau K, Vergari L, Custer E, Anyango H, Donkor WES, Kiprotich M, Siegal K, Petry N, Wirth JP, Lewycka S, Woodruff BA, Rohner F. Effectiveness of an integrated agriculture, nutrition-specific, and nutrition-sensitive program on child growth in Western Kenya: a cluster-randomized controlled trial. Am J Clin Nutr. 2022 Aug 4;116(2):446-459. doi: 10.1093/ajcn/nqac098.

  PMID: 35421217 DERIVED

MeSH Terms

Conditions

Growth Disorders

Interventions

Methods

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Rita Wegmüller

  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: February 22, 2018
• First Posted: February 28, 2018
• Study Start: March 12, 2018
• Primary Completion: July 1, 2020
• Study Completion: October 1, 2020
• Last Updated: July 28, 2021

Record last verified: 2021-07

Locations

KE (1)