Counseling Clinical Trial
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
NCT number | NCT03627156 |
Other study ID # | 092/18-04 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2018 |
Est. completion date | May 31, 2019 |
Verified date | June 2019 |
Source | Bahir Dar University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 712 |
Est. completion date | May 31, 2019 |
Est. primary completion date | August 20, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Ethiopia | Bahir Dar University | Bahir Dar |
Lead Sponsor | Collaborator |
---|---|
Bahir Dar University |
Ethiopia,
Abu-Saad K, Fraser D. Maternal nutrition and birth outcomes. Epidemiol Rev. 2010;32:5-25. doi: 10.1093/epirev/mxq001. Epub 2010 Mar 17. Review. — View Citation
Asayehu TT, Lachat C, Henauw S, Gebreyesus SH. Dietary behaviour, food and nutrient intake of women do not change during pregnancy in Southern Ethiopia. Matern Child Nutr. 2017 Apr;13(2). doi: 10.1111/mcn.12343. Epub 2016 Jul 3. — View Citation
Changamire FT, Mwiru RS, Msamanga GI, Spiegelman D, Urassa W, Hertzmark E, Fawzi WW, Peterson KE. Macronutrient and sociodemographic determinants of gestational weight gain among HIV-negative women in Tanzania. Food Nutr Bull. 2014 Mar;35(1):43-50. — View Citation
Fall C. Maternal nutrition: effects on health in the next generation. Indian J Med Res. 2009 Nov;130(5):593-9. Review. — View Citation
Glanz K, Rimer BK, Viswanath K, editors. Health behavior and health education : theory, research, and practice / . 4th ed. San Francisco: Jossey-Bass; 2008.
Kanadys WM. Maternal underweight and pregnancy outcome: prospective cohort study. Archives of Perinatal Medicine. 2007;13(3):23-6.
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WHO Recommendations on Antenatal Care for a Positive Pregnancy Experience. Geneva: World Health Organization; 2016. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dietary practice (dietary intake) | 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 | 10 month of intervention | |
Secondary | nutritional status | Improve mid-upper arm circumference (cm) of the pregnant women after intervention. | 10 months of intervention | |
Secondary | Birth weight | Increase in birth weight (gram) after intervention | 10 month of intervention | |
Secondary | Dietary practice | 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 | 10 weeks (baseline) |
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