Evaluation Nutrition Education Intervention on Pulse and Cereal Mix for Complementary Food in Southern Ethiopia
Primary Purpose
Dietary Habits, Health Knowledge, Attitudes, Practices, Wasting
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
enhanced education on pulse use in complementary foods
Sponsored by
About this trial
This is an interventional prevention trial for Dietary Habits
Eligibility Criteria
Inclusion Criteria:
- Age 6-15 months
- Apparently healthy
- Being breastfed at time of recruitment
- The mothers are permanent residents of the kebele
Exclusion Criteria:
- Infant undergoing treatment with supplemental foods for malnutrition
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Usual education
Enhanced Education
Arm Description
Households in the control clusters (kebeles) will receive usual nutrition education from Health extension workers, about complementary foods, over 9 months.
Additional education sessions from Health extension workers (HEWs) trained on use of pulses for complementary foods (CF). HEWs provide nutrition education programs and counseling about pulse-cereal mix complementary foods, over 9 months.
Outcomes
Primary Outcome Measures
Maternal knowledge, attitudes and practices towards pulse-cereal mix complementary food
Using validated questions on knowledge, attitude and practices
Secondary Outcome Measures
Weight for height Z-score of children
Change in z-score of measured weight and measured height (length) ratio at 9 months
Zinc status of children
Measurement of serum zinc against WHO standards
Iron status
iron status as determined by serum ferritin corrected for inflammation using markers, whole hemoglobin to define anemia status using WHO standards.
Full Information
NCT ID
NCT02638571
First Posted
December 18, 2015
Last Updated
October 25, 2018
Sponsor
University of Saskatchewan
Collaborators
Hawassa University
1. Study Identification
Unique Protocol Identification Number
NCT02638571
Brief Title
Evaluation Nutrition Education Intervention on Pulse and Cereal Mix for Complementary Food in Southern Ethiopia
Official Title
Evaluation of the Effectiveness of Nutrition Education Intervention Among Rural Mothers on Pulse and Cereal Mix Complementary Food and Nutritional Status of Children Age 6-24 Months in Sidama Zone, Southern Ethiopia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
January 19, 2016 (Actual)
Primary Completion Date
November 22, 2016 (Actual)
Study Completion Date
November 22, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan
Collaborators
Hawassa University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The overall purpose of the study is to evaluate nutrition education interventions to promote pulse incorporated complementary food to the wider rural community through the government system to improve maternal knowledge, attitude and practice (KAP) and nutritional status of young children (6 to 24 months). The hypothesis is that nutrition education improves mothers knowledge, attitude and practice of pulse incorporated complementary food and improves dietary intake of iron and zinc and nutritional status of young children.
Detailed Description
Only 9% of the population in Southern Ethiopia consumes pulse and pulse total contribution of the diet is less than 4.9% for women and less than 3.3% for children.Young children are at risk of developing malnutrition because of dietary inadequacy. Educational interventions can improve feeding practices and growth of young children. The overall purpose of the study is to evaluate nutrition education interventions to promote pulse incorporated complementary food to the wider rural community through the government system to improve maternal knowledge, attitude and practice (KAP) and nutritional status of young children (6 to 24 months). The hypothesis is that nutrition education improves mothers knowledge, attitude and practice of pulse incorporated complementary food and improves dietary intake of iron and zinc and nutritional status of young children. Before, at midline and end of the intervention we will assess the KAP of mothers, dietary intake of iron and zinc and nutritional status of young children. The nutrition education intervention will be given for 9 months. Serum ferritin, serum zinc, C-Reactive protein and hemoglobin and dietary intake of iron and zinc of young children will be measured at the beginning and ending of the intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dietary Habits, Health Knowledge, Attitudes, Practices, Wasting
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
772 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual education
Arm Type
Sham Comparator
Arm Description
Households in the control clusters (kebeles) will receive usual nutrition education from Health extension workers, about complementary foods, over 9 months.
Arm Title
Enhanced Education
Arm Type
Experimental
Arm Description
Additional education sessions from Health extension workers (HEWs) trained on use of pulses for complementary foods (CF). HEWs provide nutrition education programs and counseling about pulse-cereal mix complementary foods, over 9 months.
Intervention Type
Other
Intervention Name(s)
enhanced education on pulse use in complementary foods
Intervention Description
Enhanced Nutrition education with sessions and counseling by health extension workers
Primary Outcome Measure Information:
Title
Maternal knowledge, attitudes and practices towards pulse-cereal mix complementary food
Description
Using validated questions on knowledge, attitude and practices
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Weight for height Z-score of children
Description
Change in z-score of measured weight and measured height (length) ratio at 9 months
Time Frame
9 months
Title
Zinc status of children
Description
Measurement of serum zinc against WHO standards
Time Frame
9 months
Title
Iron status
Description
iron status as determined by serum ferritin corrected for inflammation using markers, whole hemoglobin to define anemia status using WHO standards.
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
15 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 6-15 months
Apparently healthy
Being breastfed at time of recruitment
The mothers are permanent residents of the kebele
Exclusion Criteria:
Infant undergoing treatment with supplemental foods for malnutrition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol J Henry, PhD
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Only mean (or median) data will be published. If there are correlations or regressions the r or r2 will be published
Citations:
PubMed Identifier
23237638
Citation
Amare B, Moges B, Fantahun B, Tafess K, Woldeyohannes D, Yismaw G, Ayane T, Yabutani T, Mulu A, Ota F, Kassu A. Micronutrient levels and nutritional status of school children living in Northwest Ethiopia. Nutr J. 2012 Dec 13;11:108. doi: 10.1186/1475-2891-11-108.
Results Reference
background
PubMed Identifier
23746776
Citation
Bhutta ZA, Das JK, Rizvi A, Gaffey MF, Walker N, Horton S, Webb P, Lartey A, Black RE; Lancet Nutrition Interventions Review Group, the Maternal and Child Nutrition Study Group. Evidence-based interventions for improvement of maternal and child nutrition: what can be done and at what cost? Lancet. 2013 Aug 3;382(9890):452-477. doi: 10.1016/S0140-6736(13)60996-4. Epub 2013 Jun 6. Erratum In: Lancet. 2013 Aug 3;382(9890):396.
Results Reference
background
Citation
Hirvone K, & Hoddinot J. Agricultural production and children's diets: Evidence from rural Ethiopia. EDRI & IFPRI, working paper 69.
Results Reference
background
Citation
Kebebu A, Whiting S, & Henry C. Formulation of a complementary food fortified with broad beans (vicia faba) in Southern Ethiopia. African Journal of Food, Agriculture, Nutrition and Development. 2013; 13(3): 7789-7803.
Results Reference
background
Citation
Kuma T. Analysis of changes in Food Consumption Pattern in Urban Ethiopia. EDRI. 2010.
Results Reference
background
PubMed Identifier
25639132
Citation
Negash C, Belachew T, Henry CJ, Kebebu A, Abegaz K, Whiting SJ. Nutrition education and introduction of broad bean-based complementary food improves knowledge and dietary practices of caregivers and nutritional status of their young children in Hula, Ethiopia. Food Nutr Bull. 2014 Dec;35(4):480-6. doi: 10.1177/156482651403500409.
Results Reference
background
Citation
Tefera T. Determinants of smallholder pulse producers market orientation in Southern Ethiopia. Asian Journal of Business Management. 2014; 6(2); 97-103.
Results Reference
background
Citation
Berhanu G, Henry CJ, Whiting SJ, Green TJ. 2017 Assessment of knowledge, attitude and practice of mothers on pulse incorporated complementary food and its correlations with diet diversity and nutritional status of their children aged 6-15 months in two rural districts of Sidama, South Ethiopia. International Journal of Nutritional Sciences (Special Issue on Malnutrition). 2(1): id1017 (2017).
Results Reference
result
PubMed Identifier
32962685
Citation
Teshome GB, Whiting SJ, Green TJ, Mulualem D, Henry CJ. Scaled-up nutrition education on pulse-cereal complementary food practice in Ethiopia: a cluster-randomized trial. BMC Public Health. 2020 Sep 22;20(1):1437. doi: 10.1186/s12889-020-09262-8.
Results Reference
derived
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Evaluation Nutrition Education Intervention on Pulse and Cereal Mix for Complementary Food in Southern Ethiopia
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