NCT02638571

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
772

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 23, 2015

Completed
27 days until next milestone

Study Start

First participant enrolled

January 19, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2016

Completed
Last Updated

May 8, 2024

Status Verified

October 1, 2018

Enrollment Period

10 months

First QC Date

December 18, 2015

Last Update Submit

May 7, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Maternal knowledge, attitudes and practices towards pulse-cereal mix complementary food

    Using validated questions on knowledge, attitude and practices

    9 months

Secondary Outcomes (3)

  • Weight for height Z-score of children

    9 months

  • Zinc status of children

    9 months

  • Iron status

    9 months

Study Arms (2)

Usual education

SHAM COMPARATOR

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 Education

EXPERIMENTAL

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

Interventions

Enhanced Nutrition education with sessions and counseling by health extension workers

Enhanced EducationUsual education

Eligibility Criteria

Age6 Months - 15 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age 6-15 months
  • Apparently healthy
  • Being breastfed at time of recruitment
  • The mothers are permanent residents of the kebele

You may not qualify if:

  • Infant undergoing treatment with supplemental foods for malnutrition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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.

    PMID: 23237638BACKGROUND
  • 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.

    PMID: 23746776BACKGROUND
  • Hirvone K, & Hoddinot J. Agricultural production and children's diets: Evidence from rural Ethiopia. EDRI & IFPRI, working paper 69.

    BACKGROUND
  • 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.

    BACKGROUND
  • Kuma T. Analysis of changes in Food Consumption Pattern in Urban Ethiopia. EDRI. 2010.

    BACKGROUND
  • 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.

    PMID: 25639132BACKGROUND
  • Tefera T. Determinants of smallholder pulse producers market orientation in Southern Ethiopia. Asian Journal of Business Management. 2014; 6(2); 97-103.

    BACKGROUND
  • 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).

    RESULT
  • 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.

MeSH Terms

Conditions

Feeding BehaviorBehaviorCachexia

Condition Hierarchy (Ancestors)

Behavior, AnimalWeight LossBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsThinness

Study Officials

  • Carol J Henry, PhD

    University of Saskatchewan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

December 18, 2015

First Posted

December 23, 2015

Study Start

January 19, 2016

Primary Completion

November 22, 2016

Study Completion

November 22, 2016

Last Updated

May 8, 2024

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Only mean (or median) data will be published. If there are correlations or regressions the r or r2 will be published