NCT02620943

Brief Summary

Background: Maternal and child under-nutrition is the underlying cause of death for millions across the globe. Anemia during pregnancy is among the leading nutritional disorders with serious short and long term consequences to both the mother and fetus. Objective: Examine the effect of dietary diversity on maternal anemia, nutritional status and key pregnancy outcomes of pregnancy. Methods: A prospective cohort study design, involving a total of 432 eligible pregnant women, in their second antenatal care visit was conducted between August 2014 to March, 2015. The individual dietary diversity Score (IDDS) was used as the exposure variable to select, enroll and follow the mothers. Epi-data, SPSS and STATA software are used to enter and analyze the data. Chi-square test, independent 't'-test, and GLM are used to calculate risk, association and differences between key variables at P \< 0.05

Trial Health

87
On Track

Trial Health Score

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

Enrollment
374

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

August 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 3, 2015

Completed
Last Updated

December 3, 2015

Status Verified

November 1, 2015

Enrollment Period

7 months

First QC Date

November 25, 2015

Last Update Submit

December 2, 2015

Conditions

Keywords

AnemiaPregnancy OutcomePregnancyDietary DiversityBirth Weight

Outcome Measures

Primary Outcomes (4)

  • Change in Anemia during pregnancy

    Hemoglobin levels has been taken at each visit and were used for classification of outcomes

    Change from baseline (24- 28 weeks ) to 9 month of gestation).

  • Low birth weight

    Birth weight was recorded immediately after delivery in gms at the center by attending

    Immediately at delivery

  • Pre-term birth

    Gestational age was recorded in weeks at birth

    Immediately at delivery

  • Still Birth

    Survival and living status of the baby was recorded at birth by midwives attending the labour

    Immediately at delivery

Study Arms (2)

Exposed Group

Pregnant mothers reporting inadequate (\<4) dietary diversity during pregnancy

Unexposed group

Pregnant mothers reporting adequate (\>=4) dietary diversity during pregnancy

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Pregnant women in rural Ethiopia

You may qualify if:

  • Pregnant women who are :
  • Willing to stay in the study throughout the study
  • Visit same health center for the antenatal and delivery care services
  • pregnant mother has lived for at least six months in the study area

You may not qualify if:

  • Pregnant women who have known medical, surgical or obstetric problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Addis Ababa University, Center for FDSC and Nutrition

Addis Ababa, Select State, 1196, Ethiopia

Location

Related Publications (3)

  • 1. Ruel MT. Is Dietary Diversity an Indicator of Food Security or Dietary Quality? A Review of Measurement Issues and Research Needs: Discussion Paper. Washington, DC 2006 USA; 2006. 2. UN Standing Committee on Nutrition. Fact sheets on Food and Nutrition Security Indicators/Measures: Dietary Diversity (DD). 2008. 3. Moges T, Birks KA, Samuel A, Kebede A, Zerfu D, Abera A, et al. Diet diversity is negatively associated with stunting among Ethiopian children 6-23 months of age. Addis Ababa, Ethiopia; 2013. 4. Arimond M, Ruel MT. Dietary Diversity, Dietary Quality, and Child Nutritional Status: Evidence from Eleven Demographic and Health Surveys. Am Soc Nutr Sci. 2004; 5. Acham H, Oldewage-theron WH, Egal AA. Dietary diversity , micronutrient intake and their variation among black women in informal settlements in South Africa : A cross-sectional study. 2012;4(February):24-39. 6. Papadaki A, Vardavas C, Hatzis C, Kafatos A. Calcium , nutrient and food intake of Greek Orthodox Christian monks during a fasting and non-fasting week. Public Health Nutr. 2007;11(10):1022-9. 7. Nevin S Scri nshat' and JPS. Synergism of nutrition , an overview13 and immunity. Am J Cli,, Nutr. 1997;66:464S - 77S. 8. Nutrition and Consumer Protection Division, FAO U. Guidelines for measuring household and individual dietary diversity. Rome, Italy; 2011. 9. Bilinsky AS and P. Household Dietary Diversity Score (HDDS) for Measurement of Household Food Access: Indicator Guide. 2006;Version 2. 10. Steyn NP, Nel JH, Nantel G, Kennedy G, Labadarios D. Food variety and dietary diversity scores in children : are they good indicators of dietary adequacy ? Public Health Nutr. 2006;9(5):644-50.

    RESULT
  • Zerfu TA, Baye K, Faber M. Dietary diversity cutoff values predicting anemia varied between mid and term of pregnancy: a prospective cohort study. J Health Popul Nutr. 2019 Dec 13;38(1):44. doi: 10.1186/s41043-019-0196-y.

  • Zerfu TA, Umeta M, Baye K. Dietary diversity during pregnancy is associated with reduced risk of maternal anemia, preterm delivery, and low birth weight in a prospective cohort study in rural Ethiopia. Am J Clin Nutr. 2016 Jun;103(6):1482-8. doi: 10.3945/ajcn.115.116798. Epub 2016 May 11.

MeSH Terms

Conditions

AnemiaStillbirthBirth Weight

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesFetal DeathPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDeathPathologic ProcessesPathological Conditions, Signs and SymptomsBody WeightSigns and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2015

First Posted

December 3, 2015

Study Start

August 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

December 3, 2015

Record last verified: 2015-11

Locations