Gestational Diabetes Mellitus in Pregnancy Clinical Trial
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
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.
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).
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