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Evaluation Nutrition Education Intervention on Pulse and Cereal Mix for Complementary Food in Southern Ethiopia

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ClinicalTrials.gov Identifier: NCT02638571
Recruitment Status : Completed
First Posted : December 23, 2015
Last Update Posted : October 29, 2018
Sponsor:
Collaborator:
Hawassa University
Information provided by (Responsible Party):
Carol J. Henry, University of Saskatchewan

Tracking Information
First Submitted Date  ICMJE December 18, 2015
First Posted Date  ICMJE December 23, 2015
Last Update Posted Date October 29, 2018
Actual Study Start Date  ICMJE January 19, 2016
Actual Primary Completion Date November 22, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2015)
Maternal knowledge, attitudes and practices towards pulse-cereal mix complementary food [ Time Frame: 9 months ]
Using validated questions on knowledge, attitude and practices
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2015)
  • Weight for height Z-score of children [ Time Frame: 9 months ]
    Change in z-score of measured weight and measured height (length) ratio at 9 months
  • Zinc status of children [ Time Frame: 9 months ]
    Measurement of serum zinc against WHO standards
  • Iron status [ Time Frame: 9 months ]
    iron status as determined by serum ferritin corrected for inflammation using markers, whole hemoglobin to define anemia status using WHO standards.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation Nutrition Education Intervention on Pulse and Cereal Mix for Complementary Food in Southern Ethiopia
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Dietary Habits
  • Health Knowledge, Attitudes, Practices
  • Wasting
Intervention  ICMJE Other: enhanced education on pulse use in complementary foods
Enhanced Nutrition education with sessions and counseling by health extension workers
Study Arms  ICMJE
  • Sham Comparator: Usual education
    Households in the control clusters (kebeles) will receive usual nutrition education from Health extension workers, about complementary foods, over 9 months.
    Intervention: Other: enhanced education on pulse use in complementary foods
  • Experimental: Enhanced Education
    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: Other: enhanced education on pulse use in complementary foods
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 24, 2017)
772
Original Estimated Enrollment  ICMJE
 (submitted: December 18, 2015)
766
Actual Study Completion Date  ICMJE November 22, 2016
Actual Primary Completion Date November 22, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 15 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02638571
Other Study ID Numbers  ICMJE PULSE-HEW
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Only mean (or median) data will be published. If there are correlations or regressions the r or r2 will be published
Responsible Party Carol J. Henry, University of Saskatchewan
Study Sponsor  ICMJE University of Saskatchewan
Collaborators  ICMJE Hawassa University
Investigators  ICMJE
Principal Investigator: Carol J Henry, PhD University of Saskatchewan
PRS Account University of Saskatchewan
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP