NCT03627156

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

Completed NA Last updated 6 June 2019

What this trial tests

NA trial testing guided counseling in Counseling in 712 participants. Completed in 31 May 2019.

Timeline

1 May 2018

Primary endpoint
20 August 2018

31 May 2019

Quick facts

Lead sponsor	Bahir Dar University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	712
Start date	1 May 2018
Primary completion	20 August 2018
Estimated completion	31 May 2019
Sites	1 location across Ethiopia

Drugs / interventions tested

• guided counseling

Conditions studied

• Counseling — all drugs for Counseling →

Sponsor

Bahir Dar University

Who can join

Eligibility, female only, with Counseling. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Dietary practices and associated factors among pregnant women in West Gojjam Zone, Northwest Ethiopia.
   Demilew YM, Alene GD, Belachew T. · · 2020 · cited 64× · PMID 31906981 · DOI 10.1186/s12884-019-2702-z
2. Effect of guided counseling on dietary practices of pregnant women in West Gojjam Zone, Ethiopia.
   Demilew YM, Alene GD, Belachew T. · · 2020 · cited 21× · PMID 32453774 · DOI 10.1371/journal.pone.0233429
3. Effect of guided counseling on nutritional status of pregnant women in West Gojjam zone, Ethiopia: a cluster-randomized controlled trial.
   Demilew YM, Alene GD, Belachew T. · · 2020 · cited 17× · PMID 32345286 · DOI 10.1186/s12937-020-00536-w
4. Effects of guided counseling during pregnancy on birth weight of newborns in West Gojjam Zone, Ethiopia: a cluster-randomized controlled trial.
   Demilew YM, Alene GD, Belachew T. · · 2020 · cited 14× · PMID 33023521 · DOI 10.1186/s12887-020-02363-8