The WinFood Intervention Study: the effect of improved complementary foods on nutrition and health among infants in Western Kenya
| ISRCTN | ISRCTN30012997 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30012997 |
| Secondary identifying numbers | N/A |
- Submission date
- 30/03/2012
- Registration date
- 11/05/2012
- Last edited
- 17/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims:
The World Health Organization recommends that infants be exclusively breastfed with no other food or liquid given until the age of 6 months. At 6 months, other foods need to be introduced to complement breast milk. In developing countries, including Kenya, such foods introduced at the age of 6 months or earlier mainly comprise thin porridges made exclusively from plant based foodstuffs. It is likely that the sharp growth faltering observed from 6 months onto 2 years and beyond is associated with consumption of foods that provide inadequate energy and sub-optimal amounts of essential nutrients such as iron and zinc. The Winfood Project is a collaboration between University of Copenhagen and University of Nairobi aiming to improve the quality of complementary foods fed to infants and young children in Kenya so as to improve growth and health via utilisation of often neglected traditional foodstuffs such as small fish, edible insects and grains and processing them in a way that nutrient and energy density is enhanced.
The trial aims to test the effect of three foods:
Winfood Classic with maize, grain amaranth, edible termites and fish
Winfood Lite maize, grain amaranth and premix of vitamins and minerals
Corn soy blend plus (CSB+) with mineral and vitamin premix
The effect on growth, lean and body fat composition, gross psychomotor milestones, zinc and iron status of Kenyan infants and young children supplemented for 9 months from 6-15 months of age will be measured.
Who can participate?
Normal infants living in rural Western Kenya - all non-malnourished, non-severely anaemic 6-month old infants. In total 500 infants will take part for 9 months.
What does the study involve?
Six-month old infants are randomly allocated to one of the three study foods, listed above. In order to monitor growth, weight, length, head circumference, and mid upper arm circumferences are measured monthly. Haemoglobin, is measured by finger prick and venous blood is drawn to measure iron and zinc status at 6 months and 15 months of age. In order to determine lean mass and body fat composition in the infants, saliva samples are drawn and analysed.
What are the possible benefits and risks of participating?
The benefits include receiving food rations for 9 months. Additionally, we expect improved growth and health among infants receiving food supplementation. There may be discomfort to children due to pain during drawing of blood. Otherwise there are no direct risks that may be associated with this study.
Where is the study run from?
This study is based in three rural health centres in Mumias District, Western Province, Kenya.
When is study starting and how long is it expected to run for?
The study commenced in January 2012 and is expected to run until January 2013.
Who is funding the study?
Danish International Development Agency (DANIDA)
Who is the main contact?
Prof Henrik Friis
hfr@life.ku.dk
Contact information
Scientific
University of Copenhagen
Rolighedsvej 30
Frederiksberg
1958
Denmark
| hfr@life.ku.dk |
Study information
| Study design | Randomised double-blind study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The WinFood Intervention Study: randomised controlled trial of the effect of improved complementary foods on infant growth, body composition and gross motor development in Western Kenya |
| Study acronym | WinFood |
| Study hypothesis | Improved complementary foods based on locally available traditional ingredients will improve the nutritional and health status of Kenyan infants |
| Ethics approval(s) | Kenyatta National Hospital and University of Nairobi Ethics Committee, Kenya 07 April 2011 |
| Condition | Infants at risk of undernutrition |
| Intervention | Three different pre-cooked complementary food supplements given as a porridge daily from 6-15 months of age (6-8 months: 50 g, 9-12 months: 75 g, 13-15 months: 125 g) 1. WinFood CF: amaranth grain, maize and one highly-nutritious fish and one edible termite species 2. WinFood Light: amaranth grain, maize plus vitamin-mineral premix 3. Corn-Soy-Blend Plus (CSB+) Food class (1 & 2) are the experimental and food class (3) is the control intervention |
| Intervention type | Other |
| Primary outcome measure | Changes in linear growth (stunting), fat-free body mass (deuterium dilution), iron status (serum ferritin and transferrin receptors) from baseline (age 6 months) until the end of the 9 month intervention |
| Secondary outcome measures | Changes in: 1. Physical activity (using an accelerometer, actigraph) 2. Motor milestones (questionnaire, clinic visits) 3. Morbidity 4. Haemoglobin concentration (using Haemocue) 5. Serum concentrations of acute phase proteins [C-reactive protein (CRP) and a-acid glycoprotein(AGP)], insulin-like growth factor (IGF)-1 and zinc 6. Whole blood fatty acid composition Measured from baseline (age 6 months) until the end of the 9 month intervention |
| Overall study start date | 15/01/2012 |
| Overall study end date | 30/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 450 |
| Total final enrolment | 499 |
| Participant inclusion criteria | Children who are 6 months old and have a weight-for-height z-score > -3 |
| Participant exclusion criteria | 1. Weight-for-height z-score < -3 2. Bilateral pitting oedema 3. Haemoglobin (Hb) < 80 g/L 4. Clinical signs of vitamin A deficiency (xerosis or Bitot spots). These children will be referred for treatment |
| Recruitment start date | 15/01/2012 |
| Recruitment end date | 30/12/2012 |
Locations
Countries of recruitment
- Denmark
- Kenya
Study participating centre
1958
Denmark
Sponsor information
University/education
Rolighedsvej 30
Frederiksberg
1958
Denmark
| Website | http://www.ku.dk/english/ |
|---|---|
"ROR" |
https://ror.org/035b05819 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2019 | 07/05/2019 | Yes | No |
| Results article | 14/02/2023 | 17/02/2023 | Yes | No |
Editorial Notes
17/02/2023: Publication reference added.
07/05/2019: Publication reference added.
