Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202002810799672 Date of Approval: 26/02/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness of a 3-group food guide in improving the caregivers' feeding practices and nutritional status of their children
Official scientific title Dietary Guidance to Enhance Caregivers' Food Selection Practices and their Children's Nutritional Status: A Randomized Study
Brief summary describing the background and objectives of the trial Child-caregivers’ food choices and child-feeding patterns are central to the dietary intake and nutritional status of young children under their care. Caregivers in Uganda are known to engage in inappropriate feeding practices which contributes to the high level of undernutrition especially in rural areas. Hence, this calls for interventions to improve understanding of how best to influence caregivers to engage them to engage in appropriate child-feeding practices. Between 2003 and 2006, we developed a food guide plate to help rural caregivers conceptualize the concepts of a balanced diet and dietary diversity within and across the three food groups. These studies showed that caregivers had improved knowledge and practices on what constitutes an adequate diet, feed their children better, and their children tended to have better weights than children whose caregivers were not introduced to the food guide plate. Although Infant and Young Child Feeding national counseling cards for community volunteers (which are commonly called IYCF cards) are the standard training packaged used in health centres in Uganda to educate caregivers about appropriate feeding practices, the effectiveness of these cards have not been studied. We wanted to determine if the effectiveness of the food guide was comparable to the IYCF cards. This was based on fact that IYCF cards emphasize age-appropriate infant and young child feeding, they do not include a food guide graphic to help caregivers visualize acceptable food selection patterns. Hence, this study sought to compare the effectiveness of the IYCF cards against an education program that is centered on using the food plate graphic, which is known to enhance caregivers understanding of the concepts of food variety and dietary balance.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 29/08/2014
Actual trial start date 08/11/2014
Anticipated date of last follow up 28/08/2015
Actual Last follow-up date 20/03/2015
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 118
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
HDREC 228 Makerere University College of Health Sciences IRB
SS 3465 Uganda National Council of Science and Technology
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Food guide or FG group Participants met once every week for nutrition education sessions. At each meeting, they had about one hour of theory and 3-4 hours of cooking sessions. Met once in each week for five (5) consecutive weeks. The 3-food group guide was used to guide the caregivers in food selection and understanding the need to have varied diets. The educator used both theory and cooking sessions to improve caregivers' ability to plan for and prepare balanced diets and complementary meals for their children. 40
Experimental Group IYCF Group Participants met once every week for nutrition education sessions. At each meeting, they had about one hour of theory and 3-4 hours of cooking sessions. Five weeks. The "IYCF national counseling cards for community volunteers" were used to guide the caregivers to select and prepare age appropriate complementary meals for their children. The educator used both theory and cooking sessions to improve caregivers' ability to plan for and prepare balanced diets and complementary meals for their children. 40
Control Group Hair Plaiting Group Participants met once every week for 3 to 4 hours. 5 weeks. Participants learnt how to plait different styles of hair. 38 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-All healthy children that were aged 6-14 months during the recruitment period were eligible for the study if they lived in the selected household. -All caregivers in selected households that agreed to participate. - Children born with congenital problems that affect food intake and/or growth - Caregivers that refused to take part in any of the study components Infant: 1 Month-23 Month 6 Month(s) 18 Month(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/08/2014 Makerere University School of Public Health REC
Ethics Committee Address
Street address City Postal code Country
College of Health Sciences Kampala 7072 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome - Caregivers child-feeding practices based on Child Feeding Index score. At baseline and at 8 weeks after the interventions
Primary Outcome Nutrition status of children based on weight-for-age and Mid-upper arm circumference for age At baseline and at 8 weeks after the interventions
Secondary Outcome Children dietary intake At baseline and at 8 weeks after the interventions
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kikyusa subcounty Luwero district Luwero Uganda
Bamunanika Subcounty Luwero district Luwero Uganda
Kalagala Subcounty Luwero district Luwero Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Nutrition Innovations Lab Africa Tuskeege Univeristy Department of Food and Nutritional Sciences 1200 W. Montgomery Road Room 203 Mary Starke Harper Hall Tuskegee, AL 36088, USA Tuskegee 36088 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Prof. Eunice Bonsi Department of Food and Nutritional Sciences, 1200 W. Montgomery Road, Room 203 Mary Starke Harper Hall Tuskegee 36088 United States of America Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
Prof Eunice Bonsi Department of Food and Nutritional Sciences, 1200 W. Montgomery Road, Room 203 Mary Starke Harper Hall Tuskegee 36088 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Edward Kansiime ekansiime@cees.mak.ac.ug +256704774718 Department of Science, Technical and Vocational Education Makerere University
City Postal code Country Position/Affiliation
Kampala 7062 Uganda Assistant Lecturer
Role Name Email Phone Street address
Scientific Enquiries Margaret Kabahenda mkabahenda@caes.mak.ac.ug +256781527680 Department of Food Technology and Nutrition, Food Science Building Rm 3.09
City Postal code Country Position/Affiliation
Kampala 7062 Uganda Senior Lecturer
Role Name Email Phone Street address
Public Enquiries Eunice Bonsi ebonsi@tuskegee.edu +13347278816 Department of Food and Nutritional Sciences, 1200 W. Montgomery Road, Room 203 Mary Starke Harper Hall
City Postal code Country Position/Affiliation
Tuskegee United States of America Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after de-identification Informed Consent Form,Study Protocol Immediately following publication, No end date. Data will be available for download by anyone that wishes to use on a website which will be availed to publisher (Link to be included)
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not available yet No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information