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CompletedNCT02638571Updated May 8, 2024

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

An interventional study of enhanced education on pulse use in complementary foods in Dietary Habits, Health Knowledge, Attitudes, Practices and Wasting, sponsored by University of Saskatchewan. Completed. Open to participants aged 6 Months to 15 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-08.

Sponsored by University of Saskatchewan · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
772
Allocation
Randomized
Ages
6 Months to 15 Months
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Dietary Habits
  • Health Knowledge, Attitudes, Practices
  • Wasting
03

In context

Wasting Syndrome

196 studies on the registry are indexed under Wasting Syndrome; 22 are open to participants now.

This study's enrollment of 772 is above the median of 58 across 130 interventional studies indexed under Wasting Syndrome.

Browse Wasting Syndrome studies →

Lead sponsor

University of Saskatchewan is the lead sponsor of 237 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 15 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Infant undergoing treatment with supplemental foods for malnutrition
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
772 participants (actual)

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.

    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.

    Other: enhanced education on pulse use in complementary foods

Interventions

  • Otherenhanced education on pulse use in complementary foods

    Enhanced Nutrition education with sessions and counseling by health extension workers

06

What researchers measure

Primary outcomes

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

    Using validated questions on knowledge, attitude and practices

    Time frame: 9 months

Secondary outcomes

  1. Weight for height Z-score of children

    Change in z-score of measured weight and measured height (length) ratio at 9 months

    Time frame: 9 months

  2. Zinc status of children

    Measurement of serum zinc against WHO standards

    Time frame: 9 months

  3. Iron status

    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

07

Study locations

No study locations are listed for this record.

08

References and documents

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. PubMed 23237638 ↗
  • 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. PubMed 23746776 ↗
  • 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. doi: 10.1177/156482651403500409. PubMed 25639132 ↗
  • 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. PubMed 32962685 ↗

Individual participant data

Plan to share: No — Only mean (or median) data will be published. If there are correlations or regressions the r or r2 will be published

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02638571
Lead sponsor
University of Saskatchewan
Collaborators
Hawassa University
Responsible party
Carol J. Henry (Ph.D., University of Saskatchewan) — Principal investigator
First posted
Dec 23, 2015
Start date
Jan 19, 2016
Primary completion
Nov 22, 2016
Completion
Nov 22, 2016
Last update
May 8, 2024

Study contacts

Carol J Henry, PhD
principal investigator · University of Saskatchewan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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