The Effect of Guided Counseling in Improving Dietary Practice, Nutritional Status and Birth Weight of Pregnant Women

NCT03627156 | Completed DMC

• 1 other identifier: 092/18-04
• Study Type: interventional
• Target: 712
• Locations: 1 country
• Sites: 1

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.

Conditions

Counseling

Keywords

Guided counseling; nutrition outcome; Ethiopia; Community trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• nutritional status

  10 months of intervention

• Birth weight

  10 month of intervention

• Dietary practice

  10 weeks (baseline)

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

Control Arm is an arm to which the intervention will not be implemented.

Interventions

guided counseling BEHAVIORAL

Community-based guided counseling using Health Belief Model and Theory of Planned Behavior is the intervention package for this study.

Intervention

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Diabetes millitus
• Hypertension

Sponsors & Collaborators

• Bahir Dar University: lead

Study Sites (1)

Bahir Dar University

Bahir Dar, Ethiopia

Location

Related Publications (17)

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  BACKGROUND

• 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. doi: 10.1177/156482651403500106.

  PMID: 24791578 BACKGROUND

• Rolfers SR, Pinna K, Whitney E. Understanding Normal and Clinical Nutrition,eighth edition. Wadsworth: Yolanda Cossio; 2009.

  BACKGROUND

• WHO Recommendations on Antenatal Care for a Positive Pregnancy Experience. Geneva: World Health Organization; 2016. Available from http://www.ncbi.nlm.nih.gov/books/NBK409108/

  PMID: 28079998 BACKGROUND

• Santiago SE, Park GH, Huffman KJ. Consumption habits of pregnant women and implications for developmental biology: a survey of predominantly Hispanic women in California. Nutr J. 2013 Jul 1;12:91. doi: 10.1186/1475-2891-12-91.

  PMID: 23815874 BACKGROUND

• 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.

  BACKGROUND

• Lee SE, Talegawkar SA, Merialdi M, Caulfield LE. Dietary intakes of women during pregnancy in low- and middle-income countries. Public Health Nutr. 2013 Aug;16(8):1340-53. doi: 10.1017/S1368980012004417. Epub 2012 Oct 9.

  PMID: 23046556 BACKGROUND

• Sun E, Sameera T, Mario M, Laura E. Whate are African Women Eating During Pregnancy? . FASEB Journal. 2011;25:592.

  BACKGROUND

• 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):e12343. doi: 10.1111/mcn.12343. Epub 2016 Jul 3.

  PMID: 27373896 BACKGROUND

• Fall C. Maternal nutrition: effects on health in the next generation. Indian J Med Res. 2009 Nov;130(5):593-9.

  PMID: 20090113 BACKGROUND

• 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.

  PMID: 20237078 BACKGROUND

• Sukhwinder K. Outcomes of prenatal nutrition counseling In developing countries, A Literature Review. 2010

  BACKGROUND

• Glanz K, Rimer BK, Viswanath K, editors. Health behavior and health education : theory, research, and practice / . 4th ed. San Francisco: Jossey-Bass; 2008.

  BACKGROUND

• Verbeke W. Impact of communication on consumers' food choices. Proc Nutr Soc. 2008 Aug;67(3):281-8. doi: 10.1017/S0029665108007179. Epub 2008 May 23.

  PMID: 18498672 BACKGROUND

• Demilew YM, Alene GD, Belachew T. Effects of guided counseling during pregnancy on birth weight of newborns in West Gojjam Zone, Ethiopia: a cluster-randomized controlled trial. BMC Pediatr. 2020 Oct 6;20(1):466. doi: 10.1186/s12887-020-02363-8.

  PMID: 33023521 DERIVED

• Demilew YM, Alene GD, Belachew T. Effect of guided counseling on dietary practices of pregnant women in West Gojjam Zone, Ethiopia. PLoS One. 2020 May 26;15(5):e0233429. doi: 10.1371/journal.pone.0233429. eCollection 2020.

  PMID: 32453774 DERIVED

• Demilew YM, Alene GD, Belachew T. Effect of guided counseling on nutritional status of pregnant women in West Gojjam zone, Ethiopia: a cluster-randomized controlled trial. Nutr J. 2020 Apr 28;19(1):38. doi: 10.1186/s12937-020-00536-w.

  PMID: 32345286 DERIVED

Study Officials

• Getu Alene, Phd

  Bahir Dar University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: outcome assessors are not informed about the intervention and the group to which the intervention is assigned to avoid social desirability bias
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: A two-arm parallel cluster randomized community trial

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: August 13, 2018
• Study Start: May 1, 2018
• Primary Completion: August 20, 2018
• Study Completion: May 31, 2019
• Last Updated: June 6, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

ET (1)