Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02638571
Other study ID # PULSE-HEW
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 19, 2016
Est. completion date November 22, 2016

Study information

Verified date October 2018
Source University of Saskatchewan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 772
Est. completion date November 22, 2016
Est. primary completion date November 22, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months to 15 Months
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
enhanced education on pulse use in complementary foods
Enhanced Nutrition education with sessions and counseling by health extension workers

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Saskatchewan Hawassa University

References & Publications (8)

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. — View 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 ru

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. — View Citation

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. — View Citation

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

Outcome

Type Measure Description Time frame Safety issue
Primary Maternal knowledge, attitudes and practices towards pulse-cereal mix complementary food Using validated questions on knowledge, attitude and practices 9 months
Secondary Weight for height Z-score of children Change in z-score of measured weight and measured height (length) ratio at 9 months 9 months
Secondary Zinc status of children Measurement of serum zinc against WHO standards 9 months
Secondary Iron status iron status as determined by serum ferritin corrected for inflammation using markers, whole hemoglobin to define anemia status using WHO standards. 9 months
See also
  Status Clinical Trial Phase
Completed NCT04025099 - Internal Cues Versus External Cues for Eating and Activity N/A
Recruiting NCT06094049 - Acceptability of Folic Acid and Vitamin B12 Fortified Meals
Completed NCT03720314 - Microbiota Profiling in IBS
Completed NCT03334266 - Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal - 18 Months N/A
Recruiting NCT02894931 - Effects of Dietary Interventions on Serum and Macrophage Atherogenicity N/A
Completed NCT02559076 - The Eat Right Emirates Healthy Lifestyle Study N/A
Completed NCT05502445 - The Nutritionist's Educational Intervention on the Protein Intake in Hospitalized Elderly People N/A
Active, not recruiting NCT04308473 - Analysis of MicroBial Metabolites After Eating Refined Food N/A
Completed NCT04082247 - Healthy Children 2021 Study in Childcare Centers N/A
Recruiting NCT05157815 - Study to Investigate the Effect of Dietary Fibre Supplementation on Long-term Glucose Control in Prediabetic Subjects N/A
Active, not recruiting NCT05607745 - Dietary Counseling Coupled With FMT in the Treatment of Obesity and NAFLD - the DIFTOB Study N/A
Completed NCT06045845 - Effects of Beet Juice and Diet in Female Rowers N/A
Completed NCT03775889 - Engaging School and Family in Navajo Gardening for Health N/A
Not yet recruiting NCT02910128 - Childhood Obesity Prevention Trough Education Innovation in Primary School: A Quasi-experimental Trial N/A
Completed NCT03189979 - Club Fit: Physical Activity and Healthy Eating at an After School Program N/A
Completed NCT02572479 - Evaluating the Potential of the Diet as Disease Modifier in Amyotrophic Lateral Sclerosis (JERN_ALS)
Completed NCT02102763 - Greek Childhood Obesity (GRECO) Study N/A
Completed NCT04632771 - Nutritional Status and Bouillon Use in Northern Ghana
Recruiting NCT03500458 - Impact of Sleep Extension in Adolescents N/A
Completed NCT03673267 - Nutricity: A Pilot Study to Improve Parental Nutrition Literacy N/A