Health-promoting Lifestyle Education on Women With Gestational Diabetes Mellitus

NCT ID: NCT03881956

Last Updated: 2019-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2016-06-23

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).

Conditions

Gestational Diabetes Mellitus in Pregnancy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Women with gestational diabetes

88 women with gestational diabetes (46 for the intervention group and 42 for the control group) were in the arm.

Group Type: OTHER

Health-promoting lifestyle education program

Intervention Type: BEHAVIORAL

The intervention group were included in the health-promoting lifestyle education program. 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. 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.

Interventions

Health-promoting lifestyle education program

The intervention group were included in the health-promoting lifestyle education program. 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. 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• In gestational period of 24 to 34 weeks
• Diagnosed with GDM
• Aged 18 years or older
• Volunteering to participate in the study

Exclusion Criteria

• Presence of a psychiatric disease
• Multiple pregnancy
• Risk of preterm labor, placenta previa or premature rupture of the membranes
• Not volunteering to participate in the study

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 43 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Aslı URAL

PhD Nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

443983

Identifier Type: -

Identifier Source: org_study_id