Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-30 @ 12:26 PM
Study NCT ID:
NCT03881956
Status:
COMPLETED
Last Update Posted:
2019-03-20
First Post:
2019-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Health-promoting Lifestyle Education on Women With Gestational Diabetes Mellitus
Sponsor:
Istanbul University
Organization:
Study Overview
Official Title:
The Effect of the Health-promoting Lifestyle Education Program Provided to Women With Gestational Diabetes on Maternal and Neonatal Health: A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study the effect of the Health-Promoting Lifestyle Education Program (HPLEP) provided to women with GDM on maternal and neonatal health was investigated. The education program and also usual care applied to the intervention group, only usual care applied to the control group.
Detailed Description:
The population of this study included women with GDM who received treatment in the perinatology clinic of the Istanbul Zeynep Kamil Hospital, Turkey in 2015. The records showed that 350 women with GDM were referred to the perinatology clinic in that period. The sample size was calculated using Power and Sample Size Program, with 80% power and a 0.05 margin of error, and it was determined that both the intervention and the control group should include at least 30 women with GDM. It was considered appropriate that 50 women with GDM be included in each group.
At the end of this study 46 women were in the intervention group and 42 women were in the control group.
The patients followed up in the perinatology clinic were assigned to groups through randomization (drawing lots by the clinic nurse). Data collector checked patients in the perinatology clinic daily. If there were more than one patient who met the inclusion criteria, it was determined which group to take with the lottery method. When there was only one woman with GDM in the clinic, it was determined which group to take with the lot but the next patient was taken directly to the opposite group. When two patients were in the same room, they were taken into the same group in order not to have any ethical problems. Detailed information was given to the women who met inclusion criteria and their consent was obtained using an Informed Voluntary Consent Form. The women in the both group were administered the introductory information form, the Health-Promoting Lifestyle Profile II (HPLP-II), the Center for Epidemiologic Studies Depression Scale (CES-D) and the Short Form 36 Health Survey (SF-36) in the first assessment.
The education program and also usual care applied to the intervention group. The education program consisted of three 45-min sessions, which included a face-to-face lecture with the dissemination and presentation of written and visual materials. Also each participant in the intervention group was given the Health-Promoting Lifestyle Booklet and the Diary of a Woman with GDM card. The booklet features all of the health-promoting practices (self-monitoring of blood glucose, nutrition, physical activity, stress, sleeping, smoking, self-care and breastfeeding). The Diary of a Woman with GDM card features the daily program that women should follow (the hours for main meals and snacks, insulin hours, etc.). The education and counseling were maintained through follow-up via phone for intervention group.
The women in the control group which receiving only usual care were followed according to the institution's routine diabetes follow-up protocol (monitoring blood glucose levels as frequently as indicated by the doctor, and patients are referred to dietitian and to diabetes nurse).
To assess the effectiveness of the educational program, the HPLP-II, CES-D and SF-36 were re-administered to the intervention group four weeks after the first assessment (second assessment). The HPLP-II, CES-D and SF-36 were re-administered to the both groups in the postpartum 6th week (third assessment).
At the end of this study 46 women were in the intervention group and 42 women were in the control group.
The patients followed up in the perinatology clinic were assigned to groups through randomization (drawing lots by the clinic nurse). Data collector checked patients in the perinatology clinic daily. If there were more than one patient who met the inclusion criteria, it was determined which group to take with the lottery method. When there was only one woman with GDM in the clinic, it was determined which group to take with the lot but the next patient was taken directly to the opposite group. When two patients were in the same room, they were taken into the same group in order not to have any ethical problems. Detailed information was given to the women who met inclusion criteria and their consent was obtained using an Informed Voluntary Consent Form. The women in the both group were administered the introductory information form, the Health-Promoting Lifestyle Profile II (HPLP-II), the Center for Epidemiologic Studies Depression Scale (CES-D) and the Short Form 36 Health Survey (SF-36) in the first assessment.
The education program and also usual care applied to the intervention group. The education program consisted of three 45-min sessions, which included a face-to-face lecture with the dissemination and presentation of written and visual materials. Also each participant in the intervention group was given the Health-Promoting Lifestyle Booklet and the Diary of a Woman with GDM card. The booklet features all of the health-promoting practices (self-monitoring of blood glucose, nutrition, physical activity, stress, sleeping, smoking, self-care and breastfeeding). The Diary of a Woman with GDM card features the daily program that women should follow (the hours for main meals and snacks, insulin hours, etc.). The education and counseling were maintained through follow-up via phone for intervention group.
The women in the control group which receiving only usual care were followed according to the institution's routine diabetes follow-up protocol (monitoring blood glucose levels as frequently as indicated by the doctor, and patients are referred to dietitian and to diabetes nurse).
To assess the effectiveness of the educational program, the HPLP-II, CES-D and SF-36 were re-administered to the intervention group four weeks after the first assessment (second assessment). The HPLP-II, CES-D and SF-36 were re-administered to the both groups in the postpartum 6th week (third assessment).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: