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

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.

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Sponsors and Collaborators

University of Saskatchewan

Hawassa University

Investigators

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

More Information

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:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Carol J. Henry, Ph.D., University of Saskatchewan
• ClinicalTrials.gov Identifier: NCT02638571
• Other Study ID Numbers: PULSE-HEW
• First Posted: December 23, 2015
• 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

Additional relevant MeSH terms:

Wasting Syndrome; Cachexia; Emaciation; Weight Loss; Body Weight Changes; Body Weight; Metabolic Diseases; Nutrition Disorders