search
Back to results

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
University of Saskatchewan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dietary Habits

Eligibility Criteria

6 Months - 15 Months (Child)All SexesAccepts Healthy Volunteers

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

    First Posted
    December 18, 2015
    Last Updated
    October 25, 2018
    Sponsor
    University of Saskatchewan
    Collaborators
    Hawassa University
    search

    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

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs