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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

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.

Condition or disease Intervention/treatment Phase
Dietary Habits Health Knowledge, Attitudes, Practices Wasting Other: enhanced education on pulse use in complementary foods Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 772 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : January 19, 2016
Actual Primary Completion Date : November 22, 2016
Actual Study Completion Date : November 22, 2016

Arm Intervention/treatment
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.
Other: enhanced education on pulse use in complementary foods
Enhanced Nutrition education with sessions and counseling by health extension workers

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.
Other: enhanced education on pulse use in complementary foods
Enhanced Nutrition education with sessions and counseling by health extension workers




Primary Outcome Measures :
  1. Maternal knowledge, attitudes and practices towards pulse-cereal mix complementary food [ Time Frame: 9 months ]
    Using validated questions on knowledge, attitude and practices


Secondary Outcome Measures :
  1. 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

  2. Zinc status of children [ Time Frame: 9 months ]
    Measurement of serum zinc against WHO standards

  3. 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.



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Ages Eligible for Study:   6 Months to 15 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638571


Sponsors and Collaborators
University of Saskatchewan
Hawassa University
Investigators
Principal Investigator: Carol J Henry, PhD University of Saskatchewan

Publications of Results:
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).

Other Publications:
Bhutta AZ, Das KD, Rizvi A, Gaffey FM, Walker N, Horton S, ....Black ER. Evidence-based interventions for improvement of maternal and child nutrition: What can be done and at what cost? The Lancet 2013 retrieved fro http://dx.doi.org/10.1016 on September 2015.
Hirvone K, & Hoddinot J. Agricultural production and children's diets: Evidence from rural Ethiopia. EDRI & IFPRI, working paper 69.
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.
Kuma T. Analysis of changes in Food Consumption Pattern in Urban Ethiopia. EDRI. 2010.
Tefera T. Determinants of smallholder pulse producers market orientation in Southern Ethiopia. Asian Journal of Business Management. 2014; 6(2); 97-103.

Responsible Party: Carol J. Henry, Ph.D., University of Saskatchewan
ClinicalTrials.gov Identifier: NCT02638571     History of Changes
Other Study ID Numbers: PULSE-HEW
First Posted: December 23, 2015    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
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