StuntingNCT03558464
Effectiveness Study During the First 1,000 Days in Kenya
A study testing Intervention (integrated package) in people with Stunting and Anemia, run by Fabian Rohner at 1 site in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stunting, Anemia, Micronutrient Deficiency
- What is being tested?
- Intervention (integrated package)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,199 participants
- Where
- 1 siteKenya
- Study dates
- 8 Jun 2018to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women (≥ 18 years of age) with gestational age ≤20 weeks
- Written Informed Consent as documented by signature
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of an Integrated Programme to Reduce Maternal and Child Malnutrition in Kenya: a Study in Pregnant Women and Their Offspring
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).
Read the 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.
In order to monitor and evaluate 1AF's programmes, a cluster-randomized, parallel-group, prospective, follow-up effectiveness study that will span over the "1,000 days window", the period from conception until the child's second birthday will be conducted in the Western Province of Kenya.
Clusters will be randomly assigned to either have the regular 1AF agricultural intervention package (already in place in all clusters participating in the study and therefore called control) or the integrated intervention package that on top of the agricultural package consists of nutrition-specific (such as providing additional micronutrients) and nutrition-sensitive (such as providing soap for hand washing) interventions. The impact on malnutrition and programmatic 'success' will be evaluated.
Objective/hypothesis:
While the primary purpose is to longitudinally compare the changes of biological indicators such as growth, anemia and micronutrient status between the intervention and control group, the programmatic aspects such as adherence to and coverage of the intervention package and trying to link this to changes in dietary patterns and ultimately linear growth will also be evaluated.
As such, the research hypothesis is as follows: Linear growth in children during their first 24 months of life will improve after the provision of agricultural services, nutritionally enhanced and WASH products as well as nutrition and WASH training over the period of the 1,000 days window of opportunity when compared to the control group provided only with agricultural services.
Study design:
The general study design is a cluster-randomized, parallel-group, prospective, follow-up effectiveness study over a period of 1000 days comparing 2 groups:
- Intervention group: Pregnant women will be given LNS (1 sachet/day) and an anthelminthic drug (mebendazole) in the second trimester of pregnancy, as well as soap and chlorine solution for the woman and the household. After delivery these products will be continued until the child reaches 6 months of age. Thereafter, LNS and anthelmintic drugs for mothers will be discontinued and instead, the child will receive MNP (1 sachet every three days), 1 egg per day, and Oral Rehydration Salts (ORS) along with zinc tablets (20 mg/day) for treatment in case of acute diarrhoea. These products will be given until the child reaches 2 years of age. The products will be accompanied by life stage-appropriate nutrition and WASH trainings (pregnancy, lactation, infant and young child feeding), as well as SMS reminders to highlight certain messages on antenatal care and nutrition. All products and trainings will be provided free of charge. The households in the intervention group will also have the same agricultural intervention as the control group.
- Control group: All households will be provided with agricultural training (every 2 weeks on average) for free. In addition, households can also enrol for the following products on credit: compost booster, cook stoves, seeds (onions, maize, indigenous greens, beans), maize storage bags, drying tarps, trees, solar lights, fertilizer, actellic dust (insecticide), re-usable sanitary pads.
It is anticipated to enroll 1200 (600 in each group) pregnant women into the study; this is expected to yield a sufficiently large sample of children later in the study. Women will be recruited from 140 clusters (randomly assigned to intervention or control) that will be drawn from from Kimilili, Webuye, Bumula, Sirisia and Kabuchai districts in Bungoma County in Western Province of Kenya.
The communities will be informed about the study in village meetings by CHVs and by conducting outreach within their catchment area to identify pregnant women. Pregnant women will then be screened by 1AF enumerators. During screening, a few questions on health status and pregnancy will be asked. If the woman is prior or equal to 20 weeks of gestation (according to last menstrual period), has no visible severe disease and no allergy to peanuts or milk products, and confirms anticipated residence in the area for the coming 30 months, written informed consent for her and her offspring will be sought from her. She will then be asked to provide a urine sample to confirm pregnancy and she will be enrolled if pregnancy is confirmed. Following the screening, 5 assessment rounds (baseline and 4 follow-up assessments during the intervention) will be conducted at the participant's homes (rounds 1-3) or at a central place (rounds 4 and 5) within walking distance from their homes. Assessment round 3 (immediately) after delivery will be conducted as home visits or clinic visits in case of delivery at a clinic. Details of assessment procedures for each round are illustrated below:
Round 1 (Enrolment, ≤20 wk of gestation):
On the day of enrollment the round 1 assessment will be done. As part of this, the following information will be collected: household demographics and characteristics, maternal education; knowledge, attitude and practices (KAP) of specific dietary and nutrition practices during pregnancy; individual dietary diversity; antenatal care; WASH practices; height, weight and mid-upper arm circumference; maternal haemoglobin concentration and malaria parasitaemia from a capillary blood sample. After round 1, participants randomly allocated to the intervention group will start receiving the intervention package.
Round 2 (Gestational age of 34±1 wk):
In round 2, interview questions related to diet and nutrition KAP during pregnancy, dietary diversity, antenatal care, and WASH will be asked. Additionally, MUAC (mid-upper arm circumference) will be measured and a capillary blood sample for measurement of haemoglobin concentration, malaria parasitaemia and micronutrient status will be provided.
Round 3 (Within 24-48 hours after delivery):
The mother-child pair will be visited within 24-48 hours after delivery. The following information will be recorded: delivery date and time, delivery method, recent antenatal care, and early initiation of breastfeeding. The mother will be assessed for MUAC but no blood sampling will be conducted. For the newborn, head circumference, birth weight and birth length, and haemoglobin concentration (from a heelprick) will be measured.
Round 4 (At 6.5 mo ± 1 mo of age of offspring):
This assessment will be conducted when the child turns 6.5 months old. Breastfeeding and other infant and young child feeding indicators, child morbidity, maternal dietary diversity, postnatal care, and WASH information will be gathered. In mothers, MUAC and weight will be measured and haemoglobin concentration and malaria parasitaemia from a capillary sample will be assessed. In children, length, weight and head circumference will be measured and a capillary blood sample for haemoglobin concentration, malaria parasitaemia and micronutrient status will be provided.
Round 5 (At 24 ± 1mo of age of offspring):
This assessment will be conducted when the child turns 24 months old. Questionnaire-based information on child feeding, child dietary diversity, child morbidity and WASH will be collected. As in round 4, child length, weight and head circumference will be measured and a fingerprick blood sample will be provided for the measurement of haemoglobin concentration, malaria parasitaemia, and micronutrient status. No maternal biomarkers will be collected at this point.
As part of the monthly visits to the participants' households, the 1AF health field officers will also collect data on intervention adherence and recent morbidity.
- Conditions
- Stunting, Anemia, Micronutrient Deficiency
- Being tested
- Intervention (integrated package), Control
- Medical subject headings
- Growth Disorders, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
ControlOther
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention (agriculture-focused package
+ nutrition-sensitive and nutrition-specific interventions=integrated package) Receives: Dietary Supplement: Intervention (integrated package) |
| Control | Active comparator | (agriculture-focused package) Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months of age
Stunting and length/height-for-age z-score
Change in length-for-age z-score (LAZ) between birth and 24 months of age
Measured: 2 years
Secondary outcomes (12)
Maternal hemoglobin
Change in haemoglobin concentration between 34 weeks gestation and 6 months post-partum
Measured: 8 months
Birth weight
Differences in birth weight between intervention and control group
Measured: 7 months
Birth length
Differences in birth length between intervention and control group
Measured: 7 months
Head circumference at birth
Differences in head circumference between intervention and control group
Measured: 7 months
Child hemoglobin
Change in hemoglobin concentration between at birth, 6 and 24 months of age
Measured: 2 years
Child iron deficiency
Change in proportion with inflammation-adjusted iron deficiency between 6 and 24 months of age
Measured: 18 months
Child vitamin A deficiency
Change in proportion with inflammation-adjusted vitamin A deficiency between 6 and 24 months of age
Measured: 18 months
Child diarrhea
Diarrhea incidence rate between 6 and 24 months of age
Measured: 18 months
Length-for-age z-score at birth and 6 months of age
Update (October 2025): This outcome was pre-specified in the data analysis plan (https://osf.io/rufmd) but was not originally listed in the ClinicalTrials.gov registration. This update reflects a correction of the registry to include the main planned secondary outcomes. This does not represent a post hoc addition to the initially planned statistical analyses (pre-specified in the data analysis plan).
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.
Measured: 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
Update (October 2025): This outcome was pre-specified in the data analysis plan (https://osf.io/rufmd) but was not originally listed in the ClinicalTrials.gov registration. This update reflects a correction of the registry to include the main planned secondary outcomes. This does not represent a post hoc addition to the initially planned statistical analyses (pre-specified in the data analysis plan).
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. A value below -2 SD is indicative for stunting and a value of below -3 SD for severe stunting.
Measured: At 6 months and 24 months of age
Inflammation adjusted serum ferritin concentration at 6 and 24 months of age
Update (October 2025): This outcome was pre-specified in the data analysis plan (https://osf.io/rufmd) but was not originally listed in the ClinicalTrials.gov registration. This update reflects a correction of the registry to include the main planned secondary outcomes. This does not represent a post hoc addition to the initially planned statistical analyses (pre-specified in the data analysis plan).
Measured: At 6 and 24 months of age
Retinol-binding protein at 6 and 24 months of age
Update (October 2025): This outcome was pre-specified in the data analysis plan (https://osf.io/rufmd) but was not originally listed in the ClinicalTrials.gov registration. This update reflects a correction of the registry to include the main planned secondary outcomes. This does not represent a post hoc addition to the initially planned statistical analyses (pre-specified in the data analysis plan).
Measured: At 6 and 24 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start8 Jun 2018
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StuntingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster Randomized, Parallel-group, Prospective, Follow-up Effectiveness Study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fabian Rohner
- Sponsor type
- University, hospital or other
- Collaborators
- One Acre Fund, Children's Investment Fund Foundation
- Responsible party
- Sponsor-investigator, Fabian Rohner, GroundWork
- Investigators
- Rita Wegmüller, PhD, Principal investigator, GroundWork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558464
- Sponsor's protocol ID
- GW_1AF_KenEff_1000d
- Status last verified
- Sep 2026
- First submitted
- 4 Jun 2018
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wegmuller R, Musau K, Lewycka S, Vergari L, Custer E, Anyango H, Donkor WE, Kiprotich M, Siegal K, Petry N, Wirth JP, Woodruff BA, Rohner F. Impact of an Integrated Agricultural, Nutrition, and Water, Sanitation and Hygiene Intervention during the First 1000 Days on Child Growth and Micronutrient Status in Western Kenya: A Cluster-Randomized Controlled Trial. J Nutr. 2026 Jul;156(7):101583. doi: 10.1016/j.tjnut.2026.101583. Epub 2026 May 6.
PubMed 42103157
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Integrated Programme to Reduce Maternal and Child Malnutrition in Kenya: a Study in Pregnant Women and Their Offspring
- ClinicalTrials.gov ID
- NCT03558464
- Acronym / sponsor ID
- GW_1AF_KenEff_1000d
- Conditions
- Stunting, Anemia, Micronutrient Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,199 participants (actual)
- Lead sponsor
- Fabian RohnerUniversity, hospital or other
- Collaborators
- One Acre Fund, Children's Investment Fund Foundation
- Study start
- 8 Jun 2018 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 15 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
In order to monitor and evaluate 1AF's programmes, a cluster-randomized, parallel-group, prospective, follow-up effectiveness study that will span over the "1,000 days window", the period from conception until the child's second birthday will be conducted in the Western Province of Kenya.
Clusters will be randomly assigned to either have the regular 1AF agricultural intervention package (already in place in all clusters participating in the study and therefore called control) or the integrated intervention package that on top of the agricultural package consists of nutrition-specific (such as providing additional micronutrients) and nutrition-sensitive (such as providing soap for hand washing) interventions. The impact on malnutrition and programmatic 'success' will be evaluated.
Objective/hypothesis:
While the primary purpose is to longitudinally compare the changes of biological indicators such as growth, anemia and micronutrient status between the intervention and control group, the programmatic aspects such as adherence to and coverage of the intervention package and trying to link this to changes in dietary patterns and ultimately linear growth will also be evaluated.
As such, the research hypothesis is as follows: Linear growth in children during their first 24 months of life will improve after the provision of agricultural services, nutritionally enhanced and WASH products as well as nutrition and WASH training over the period of the 1,000 days window of opportunity when compared to the control group provided only with agricultural services.
Study design:
The general study design is a cluster-randomized, parallel-group, prospective, follow-up effectiveness study over a period of 1000 days comparing 2 groups:
- Intervention group: Pregnant women will be given LNS (1 sachet/day) and an anthelminthic drug (mebendazole) in the second trimester of pregnancy, as well as soap and chlorine solution for the woman and the household. After delivery these products will be continued until the child reaches 6 months of age. Thereafter, LNS and anthelmintic drugs for mothers will be discontinued and instead, the child will receive MNP (1 sachet every three days), 1 egg per day, and Oral Rehydration Salts (ORS) along with zinc tablets (20 mg/day) for treatment in case of acute diarrhoea. These products will be given until the child reaches 2 years of age. The products will be accompanied by life stage-appropriate nutrition and WASH trainings (pregnancy, lactation, infant and young child feeding), as well as SMS reminders to highlight certain messages on antenatal care and nutrition. All products and trainings will be provided free of charge. The households in the intervention group will also have the same agricultural intervention as the control group.
- Control group: All households will be provided with agricultural training (every 2 weeks on average) for free. In addition, households can also enrol for the following products on credit: compost booster, cook stoves, seeds (onions, maize, indigenous greens, beans), maize storage bags, drying tarps, trees, solar lights, fertilizer, actellic dust (insecticide), re-usable sanitary pads.
It is anticipated to enroll 1200 (600 in each group) pregnant women into the study; this is expected to yield a sufficiently large sample of children later in the study. Women will be recruited from 140 clusters (randomly assigned to intervention or control) that will be drawn from from Kimilili, Webuye, Bumula, Sirisia and Kabuchai districts in Bungoma County in Western Province of Kenya.
The communities will be informed about the study in village meetings by CHVs and by conducting outreach within their catchment area to identify pregnant women. Pregnant women will then be screened by 1AF enumerators. During screening, a few questions on health status and pregnancy will be asked. If the woman is prior or equal to 20 weeks of gestation (according to last menstrual period), has no visible severe disease and no allergy to peanuts or milk products, and confirms anticipated residence in the area for the coming 30 months, written informed consent for her and her offspring will be sought from her. She will then be asked to provide a urine sample to confirm pregnancy and she will be enrolled if pregnancy is confirmed. Following the screening, 5 assessment rounds (baseline and 4 follow-up assessments during the intervention) will be conducted at the participant's homes (rounds 1-3) or at a central place (rounds 4 and 5) within walking distance from their homes. Assessment round 3 (immediately) after delivery will be conducted as home visits or clinic visits in case of delivery at a clinic. Details of assessment procedures for each round are illustrated below:
Round 1 (Enrolment, ≤20 wk of gestation):
On the day of enrollment the round 1 assessment will be done. As part of this, the following information will be collected: household demographics and characteristics, maternal education; knowledge, attitude and practices (KAP) of specific dietary and nutrition practices during pregnancy; individual dietary diversity; antenatal care; WASH practices; height, weight and mid-upper arm circumference; maternal haemoglobin concentration and malaria parasitaemia from a capillary blood sample. After round 1, participants randomly allocated to the intervention group will start receiving the intervention package.
Round 2 (Gestational age of 34±1 wk):
In round 2, interview questions related to diet and nutrition KAP during pregnancy, dietary diversity, antenatal care, and WASH will be asked. Additionally, MUAC (mid-upper arm circumference) will be measured and a capillary blood sample for measurement of haemoglobin concentration, malaria parasitaemia and micronutrient status will be provided.
Round 3 (Within 24-48 hours after delivery):
The mother-child pair will be visited within 24-48 hours after delivery. The following information will be recorded: delivery date and time, delivery method, recent antenatal care, and early initiation of breastfeeding. The mother will be assessed for MUAC but no blood sampling will be conducted. For the newborn, head circumference, birth weight and birth length, and haemoglobin concentration (from a heelprick) will be measured.
Round 4 (At 6.5 mo ± 1 mo of age of offspring):
This assessment will be conducted when the child turns 6.5 months old. Breastfeeding and other infant and young child feeding indicators, child morbidity, maternal dietary diversity, postnatal care, and WASH information will be gathered. In mothers, MUAC and weight will be measured and haemoglobin concentration and malaria parasitaemia from a capillary sample will be assessed. In children, length, weight and head circumference will be measured and a capillary blood sample for haemoglobin concentration, malaria parasitaemia and micronutrient status will be provided.
Round 5 (At 24 ± 1mo of age of offspring):
This assessment will be conducted when the child turns 24 months old. Questionnaire-based information on child feeding, child dietary diversity, child morbidity and WASH will be collected. As in round 4, child length, weight and head circumference will be measured and a fingerprick blood sample will be provided for the measurement of haemoglobin concentration, malaria parasitaemia, and micronutrient status. No maternal biomarkers will be collected at this point.
As part of the monthly visits to the participants' households, the 1AF health field officers will also collect data on intervention adherence and recent morbidity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster Randomized, Parallel-group, Prospective, Follow-up Effectiveness Study
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Intervention (integrated package)Intervention (agriculture-focused package + nutrition-sensitive and nutrition-specific interventions=integrated package) |
| Control | Active comparator | Other: Control(agriculture-focused package) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnant women (≥ 18 years of age) with gestational age ≤20 weeks
- Written Informed Consent as documented by signature
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 * 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). | Dietary supplement | Intervention |
| ControlActive 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 | Other | Control |
Primary outcome
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
12 secondary outcomes
Maternal hemoglobin
Time frame: 8 months
Birth weight
Time frame: 7 months
Birth length
Time frame: 7 months
Head circumference at birth
Time frame: 7 months
Child hemoglobin
Time frame: 2 years
Child iron deficiency
Time frame: 18 months
Child vitamin A deficiency
Time frame: 18 months
Child diarrhea
Time frame: 18 months
Length-for-age z-score at birth and 6 months of age
Time frame: 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
Time frame: At 6 months and 24 months of age
Inflammation adjusted serum ferritin concentration at 6 and 24 months of age
Time frame: At 6 and 24 months of age
Retinol-binding protein at 6 and 24 months of age
Time frame: At 6 and 24 months of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Derived from this study: PubMed 42103157Wegmuller R, Musau K, Lewycka S, Vergari L, Custer E, Anyango H, Donkor WE, Kiprotich M, Siegal K, Petry N, Wirth JP, Woodruff BA, Rohner F. Impact of an Integrated Agricultural, Nutrition, and Water, Sanitation and Hygiene Intervention during the First 1000 Days on Child Growth and Micronutrient Status in Western Kenya: A Cluster-Randomized Controlled Trial. J Nutr. 2026 Jul;156(7):101583. doi: 10.1016/j.tjnut.2026.101583. Epub 2026 May 6.
- Individual participant dataSharing planned: Undecided
Related trials for Stunting
RecruitingPhase 3
Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children
Growth Disorders, Growth Failure
RecruitingObservational study
Evaluation of Children With Endocrine and Metabolic-Related Conditions
Adrenal Insufficiency, Growth Disorder
Not yet recruiting
Pilot Study of a Modified Therapeutic Food Compared With a Standard Nutrient Supplement in Young Children in Rural Guatemala
Stunting of Growth, Chronic Malnutrition
RecruitingPhase 2
Statin Intervention for Severe Early-Onset Placental Insufficiency. (STATIN-PRE Trial)
Preeclampsia (PE), Intrauterine Growth Restriction (IUGR)
RecruitingPhase 3
Micronutrient Enhancement for Development and Health in Adolescents - The MEDHA Study
Neurodevelopment Outcome, Linear Growth
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rita Wegmüller, PhD principal investigator
GroundWork
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention (integrated package) in people with Stunting and Anemia, run by Fabian Rohner at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length-for-age z-score at 24 months of age (time frame: 24 months of age). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03558464, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.