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

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

Tracking Information

• First Submitted Date: December 18, 2015
• First Posted Date: December 23, 2015
• Last Update Posted Date: October 29, 2018
• Actual Study Start Date: January 19, 2016
• Actual Primary Completion Date: November 22, 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Dietary Habits
• Health Knowledge, Attitudes, Practices
• Wasting

Intervention

Other: enhanced education on pulse use in complementary foods

Enhanced Nutrition education with sessions and counseling by health extension workers

Study Arms

• 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 *

• 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.
• 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.
• 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.
• Tefera T. Determinants of smallholder pulse producers market orientation in Southern Ethiopia. Asian Journal of Business Management. 2014; 6(2); 97-103.
• 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).
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 24, 2017): 772
• Original Estimated Enrollment (submitted: December 18, 2015): 766
• Actual Study Completion Date: November 22, 2016
• Actual Primary Completion Date: November 22, 2016 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Months to 15 Months (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02638571
• Other Study ID Numbers: PULSE-HEW
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

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

• Responsible Party: Carol J. Henry, University of Saskatchewan
• Study Sponsor: University of Saskatchewan
• Collaborators: Hawassa University

Investigators

• Principal Investigator: Carol J Henry, PhD; University of Saskatchewan

• PRS Account: University of Saskatchewan
• Verification Date: October 2018