Protocol summary

Study aim
This study targeted evaluating the effect of BASNEF model-based educational intervention on gestational diabetes self-care behavior (GD-SCB) among pregnant women.
Design
A randomized clinical controlled trial
Settings and conduct
EL-Shatby hospital, Alexandria, Egypt
Participants/Inclusion and exclusion criteria
A convenient sample of pregnant women beyond 20 gestational weeks and diagnosed with GD will be included in the study. Women complaining of other chronic diseases or pregnancy-induced complications and missing more than two educational intervention sessions will be omitted from the study.
Intervention groups
The BASNEF model-based empowerment educational intervention will be carried out in four sequential phases. Needs assessment: A pre-test will be carried out to assess the participants' knowledge, PB, attitude, SN, BI, EF, and GD-SCB. The needs assessment phase's objectives will address the participants' educational needs and collect basic data for subsequent comparison. Planning: Based on the needs assessment results, an educational intervention using the BASNEF model will be designed in view of the current literature. The intervention will be composed of five sessions. Implementation: The educational session will be conducted for 3 to 4 women at each time. At the beginning of each session, a summary of the previous content will be done. Numerous printed materials will be used to stimulate knowledge retention and make concepts reinforcement to support desired changes. The participants will be accessed through phones to arrange for the sessions. Evaluation: Two months after intervention, the post-test will be done to evaluate the women's knowledge, PB, attitude, SN, BI, EF, and GD-SCB. If the women cannot attend the antenatal clinic, a telephone interview will be conducted to complete the post-test.
Main outcome variables
gestational diabetes self-care

General information

Reason for update
Acronym
BASNEF, GD-SCB
IRCT registration information
IRCT registration number: IRCT20210131050192N1
Registration date: 2021-02-10, 1399/11/22
Registration timing: prospective

Last update: 2021-02-10, 1399/11/22
Update count: 0
Registration date
2021-02-10, 1399/11/22
Registrant information
Name
Wafaa Elgzar
Name of organization / entity
Damanhour University
Country
Egypt
Phone
+20 13 2265261
Email address
wafaa.elgzar@nur.dmu.edu.eg
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-15, 1399/11/27
Expected recruitment end date
2021-06-20, 1400/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Gestational Diabetes Self-Care Behavior: An Empowerment Educational Intervention Based on BASNEF Model
Public title
Effect of BASNEF- based education on gestational diabetes self-care
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
A convenient sample of pregnant women beyond 20 gestational weeks Diagnosed with GD will be included in the study.
Exclusion criteria:
Women complaining of other chronic diseases or pregnancy-induced complications missing more than two educational intervention sessions
Age
From 20 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 180
Randomization (investigator's opinion)
Randomized
Randomization description
A convenience sample of 220 pregnant women will be incorporated to compensate for the expected participants' loss. They will randomly assigned to either intervention or control group using the randomization block technique, which will be performed according to five sequential steps. First, a numbers’ list will be prepared in advance, from 1 to 220. Second, these numbers will be written on small pieces of paper and rolled to hide the numbers, then mixed in a ball. Third, a random division of the 220 paper pieces into 22 blocks will be performed, where each one contains ten pieces of paper. Fourth, five papers will be randomly picked from each block to be assigned to the intervention group, and the remaining five papers will be assigned to the control group. Fifth, in front of each number in the previously prepared list, the researchers will write the word "intervention" or " control" according to the randomization block technique results. The prepared list will be kept in a closed envelope to be considered at the time of data collection. A total of 110 participants will be assigned to each group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Nursing College, Damanhour University
Street address
18, Ataa Elithy street
City
Damanhour
Postal code
55461
Approval date
2019-01-13, 1397/10/23
Ethics committee reference number
13-01-02-2019 EC

Health conditions studied

1

Description of health condition studied
Gestational diabetes
ICD-10 code
O24419
ICD-10 code description
Gestational diabetes mellitus in pregnancy, unspecified control

Primary outcomes

1

Description
Diabetes Self-Care Behavior
Timepoint
Two months after intervention
Method of measurement
interviewing schedule involving three parts: socio-demographic characteristics and obstetrics/medical history, BASNEF model questionnaire, and gestational diabetes self-care behavior scale.

Secondary outcomes

empty

Intervention groups

1

Description
For the intervention group: (The BASNEF model-based empowerment educational intervention will be carried out in four sequential phases) Needs assessment: A pre-test will be carried out to assess the participants' knowledge, PB, attitude, SN, BI, EF, and GD-SCB. The latter included diet, physical activities, insulin regimen, antenatal follow-up, glucose monitoring, and hypo/hyperglycemia management. The needs assessment phase's objectives is to address the participants' educational needs and collect basic data for subsequent comparison. Planning: Based on the needs assessment results, an educational intervention using the BASNEF model will be designed in view of the current literature. The intervention will be composed of five sessions. The first session will be designed to increase the participants’ knowledge about GD pathophysiology, sign and symptoms, risk factors, diagnostic criteria, complications, management strategies, and lifestyle modifications. The second session will explain GD-SCB, including diabetic diet, physical activities, insulin regimen, antenatal follow-up, glucose monitoring, and hypo/hyperglycemia management. The third session will be concerned with correcting any misinformation about GD to foster positive attitude and beliefs among women about GD and SCB. The fourth session will address the SN and EF that affect the women's intention for SCB. The fifth session will discuss the participants’ questions and addressing their individual needs and problems. PowerPoint presentations, printed booklets, and audiovisual aids will be prepared for the intervention. Implementation: The educational sessions will be conducted in a private room in the outpatient department, with the nursing staff's cooperation. The educational session will be conducted for 3 to 4 women at each time. The teaching strategies will include lecture, group discussion, and brainstorming. Each educational session assumed to last from 30 to 45 minutes. At the end of each session, a summary of the content will be provided, and questions to ensure understanding. At the beginning of each session, a summary of the previous content will be done. Numerous printed materials will be used to stimulate knowledge retention and make concepts reinforcement to support desired changes. The participants will be accessed through phones to arrange for the sessions. Evaluation: Two months after intervention, the post-test will be done to evaluate the women's knowledge, PB, attitude, SN, BI, EF, and GD-SCB. If the women cannot attend the antenatal clinic, a telephone interview will be conducted to complete the post-test.
Category
Lifestyle

2

Description
For the control group: A pre-test will be conducted, then they left for the routine hospital care, and revaluation will be done after two months from the pre-test. The printed materials will be provided to the control group after finishing the evaluation phase to maximize the educational intervention benefits.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
El Shatby hospital
Full name of responsible person
Heba Abdelftah
Street address
Elshatby street
City
Alexandria
Postal code
55461
Phone
+20 13 2465461
Email
heba_esmael18@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Damanhour University
Full name of responsible person
Wafaa Taha Elgzar
Street address
Ataa Elithy
City
Damanhour
Postal code
55461
Phone
+20 13 2465461
Email
wafaa.elgzar@nur.dmu.edu.eg
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Damanhour University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Damanhour University
Full name of responsible person
Wafaa Taha Elgzar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Obstetrics and gynecology nursing
Street address
Alfaisalia
City
Damanhour
Province
Elbehira
Postal code
55461
Phone
002013465461
Email
wafaa.elgzar@nur.dmu.edu.eg

Person responsible for scientific inquiries

Contact
Name of organization / entity
Damanhour University
Full name of responsible person
Wafaa Taha Elgzar
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
obstetrics and gynecology nursing
Street address
Alfaisalia
City
Damanhour
Province
Elbehira
Postal code
55461
Phone
002013465461
Email
wafaa.elgzar@nur.dmu.edu.eg

Person responsible for updating data

Contact
Name of organization / entity
Damanhour University
Full name of responsible person
Wafaa Taha Elgzar
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
obstetrics and gynecology nursing
Street address
Alfaisalia
City
Najran
Province
Elbehira
Postal code
55461
Phone
002013465461
Email
wafaa.elgzar@nur.dmu.edu.eg

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...