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Trial record 1 of 7 for:    Bahir Dar, Ethiopia
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The Effect of Guided Counseling in Improving Dietary Practice, Nutritional Status and Birth Weight of Pregnant Women

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ClinicalTrials.gov Identifier: NCT03627156
Recruitment Status : Completed
First Posted : August 13, 2018
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Yeshalem Mulugeta Demilew, Bahir Dar University

Brief Summary:

Poor dietary intake affects maternal wellbeing, fetal growth, and development. However, many pregnant women in Ethiopia have poor dietary intake. To improve the dietary intake of pregnant women, nutrition education is often given at the community level during a home visit and at the health institution during antenatal care. Yet, there is no evidence on the effect of nutrition education on dietary intake, nutritional status, and birth weight in the study area. Hence, the objective of this study was to evaluate the effect of guided counseling in improving dietary practice, nutritional status and birth weight of pregnant women.

A two-arm parallel cluster randomized community trial was conducted among pregnant women in West Gojjam Zone, Amhara region, Ethiopia from May 2019 to May 2019. Baseline data on dietary practice and nutritional status of pregnant women were collected from May to August 2018 (13weeks). Endline data were collected from October 2018 to May 2019. Guided counseling using the health belief model and theory of planned behavior was given in the intervention arm (11 clusters) for 10 months.

Pregnant women were selected using a cluster sampling method. A validated interviewer-administered structured questionnaire was used for collecting data on the study subjects both at the baseline and after the intervention. Data were checked, coded and double entered into Epi-Info version 7.2.2 and exported to SPSS version 23 for statistical analysis. The outcome of the study finding could be useful for health and nutrition policymakers and other concerned bodies in decision making and to design effective intervention strategies to improve dietary practices of pregnant women as a result to prevent malnutrition. 19,553 US dollar was needed to conduct the study.


Condition or disease Intervention/treatment Phase
Counseling Behavioral: guided counseling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 712 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A two-arm parallel cluster randomized community trial
Masking: Single (Outcomes Assessor)
Masking Description: outcome assessors are not informed about the intervention and the group to which the intervention is assigned to avoid social desirability bias
Primary Purpose: Treatment
Official Title: The Effect of Guided Counseling in Improving Dietary Practice, Nutritional Status and Birth Weight of Pregnant Women in West Gojjam Zone, Amhara Region, Ethiopia: A Cluster Randomized Controlled Community Trial
Actual Study Start Date : May 1, 2018
Actual Primary Completion Date : August 20, 2018
Actual Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Intervention Arm is an arm to which community-based guided counseling using Health Belief Model and Theory of Planned Behavior will be given.
Behavioral: guided counseling
Community-based guided counseling using Health Belief Model and Theory of Planned Behavior is the intervention package for this study.

No Intervention: Control
Control Arm is an arm to which the intervention will not be implemented.



Primary Outcome Measures :
  1. Dietary practice (dietary intake) [ Time Frame: 10 month of intervention ]
    Improve dietary practice after intervention. Taking more than three meals daily plus the highest tercile of women's dietary diversity score from nine food groups plus the highest tercile of animal source food consumption plus food variety score above the mean


Secondary Outcome Measures :
  1. nutritional status [ Time Frame: 10 months of intervention ]
    Improve mid-upper arm circumference (cm) of the pregnant women after intervention.

  2. Birth weight [ Time Frame: 10 month of intervention ]
    Increase in birth weight (gram) after intervention

  3. Dietary practice [ Time Frame: 10 weeks (baseline) ]
    Baseline dietary practice of pregnant women before the implementation of intervention. Taking more than three meals daily plus the highest tercile of women's dietary diversity score from nine food groups plus the highest tercile of animal source food consumption plus food variety score above the mean



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • <16weeks of gestation
  • living in the Kebele at least for six months
  • has planned to give birth in the study area.

Exclusion criteria:

  • Diabetes millitus
  • Hypertension

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03627156


Locations
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Ethiopia
Bahir Dar University
Bahir Dar, Ethiopia
Sponsors and Collaborators
Bahir Dar University
Investigators
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Study Director: Getu Alene, Phd Bahir Dar University
Publications:
Kanadys WM. Maternal underweight and pregnancy outcome: prospective cohort study. Archives of Perinatal Medicine. 2007;13(3):23-6.
Rolfers SR, Pinna K, Whitney E. Understanding Normal and Clinical Nutrition,eighth edition. Wadsworth: Yolanda Cossio; 2009.
Smedley J, Jancey JM, Dhaliwal S, Zhao Y, Monteiro SM, Howat P. Women's reported health behaviours before and during pregnancy: A retrospective study. Health Education Journal. 2014;73(1):28-40.
Sun E, Sameera T, Mario M, Laura E. Whate are African Women Eating During Pregnancy? . FASEB Journal. 2011;25:592.
Sukhwinder K. Outcomes of prenatal nutrition counseling In developing countries, A Literature Review. 2010
Glanz K, Rimer BK, Viswanath K, editors. Health behavior and health education : theory, research, and practice / . 4th ed. San Francisco: Jossey-Bass; 2008.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yeshalem Mulugeta Demilew, Assistant professor, Bahir Dar University
ClinicalTrials.gov Identifier: NCT03627156    
Other Study ID Numbers: 092/18-04
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: I have no plan to share data for other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yeshalem Mulugeta Demilew, Bahir Dar University:
Guided counseling
nutrition outcome
Ethiopia
Community trial
Additional relevant MeSH terms:
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Birth Weight
Body Weight