Clinical trial NCT03881956: Health-promoting Lifestyle Education on Women With Gestational Diabetes Mellitus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes Mellitus in Pregnancy
Keywords: gestational diabetes
health-promoting lifestyle
maternal and neonatal health
education
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2019-03-20
Enrollment: 88
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study sample included 88 women (46 for the intervention and 42 for the control group) diagnosed with GDM. The control group received only usual care and they were followed according to the institution's diabetes follow-up protocol. In addition to the usual care, the intervention group was provided with an education program that consisted of three 45 min sessions.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. After the education program, the HPLP-II, CES-D and SF-36 were re-administered to the intervention group four weeks after the first assessment. The HPLP-II, CES-D and SF-36 were re-administered to the both groups in the postpartum 6th week.
Primary purpose: OTHER

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).

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

Primary outcomes:
measure: Change of Health-Promoting Lifestyle Profile II (HPLP II) scores
timeFrame: Four weeks after randomization and within postpartum 6th week
measure: Change of Short Form 36 Health Survey (SF-36) scores
timeFrame: Four weeks after randomization and within postpartum 6th week
measure: Change of Center for Epidemiologic Studies Depression Scale (CES-D) scores
timeFrame: Four weeks after randomization and within postpartum 6th week
measure: Pre-test and post-test scores
timeFrame: After randomization up to one week
Secondary outcomes:
measure: Postpartum diabetes control of women
timeFrame: within postpartum 6th week
measure: Postpartum characteristics of neonates
timeFrame: in postpartum first day
Other outcomes:
Locations:
Study officials:
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