The Effect of the Health-promoting Lifestyle Education Program Provided to Women With Gestational Diabetes on Maternal and Neonatal Health: A Randomized Controlled Trial
Phase: NA
Conditions: Gestational Diabetes Mellitus in Pregnancy
Sponsor: Istanbul University

The Effect of The Health-Promoting Lifestyle Education Program Provided to 
Women With Gestational Diabetes on Maternal and Neonatal Health: A 
Randomized Controlled Trial 
 
10.03.2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

The study 
This study has addressed topics of related to healthy lifestyle, in addition to nutrition 
and exercise. Topics of the Health-Promoting Lifestyle Education Program (HPLEP) 
were self-management of blood glucose, nutrition, physical activity, coping with 
stress, sleeping, smoking, self-care and breastfeeding. Within the scope of the 
HPLEP, one-to-one applied education and counseling were provided to the women 
using written and visual materials.  
Aim 
The aim of the study was to examine the effects of the HPLEP on maternal 
and neonatal health. 
Hypotheses of this study; 
H1: The HPLEP is effective for women with GDM in their adoption of a 
healthy lifestyle. 
H2: The HPLEP is effective in reducing the symptoms of depression in 
women with GDM. 
H3: The HPLEP is effective in improving the quality of life of women with 
GDM. 
H4: The HPLEP is effective in reducing postpartum neonatal complications. 
 
Desing 
The study was designed and conducted as a two group quasi-experimental study. 
Intervention group (n=46) and control group (n=42) were administered the data 
collecting tools in the first assessment. After first assessment, the intervention group 
were included in the educational program. Data collecting tools were re-administered 
four weeks after to the intervention group only. Than data collecting tools were re-
administered to the both groups in the postpartum 6th week. 
Sample 
This study was conducted in the perinatology clinic of the Istanbul Zeynep Kamil 
Hospital, Turkey in 2015. The records show 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.  
 
The inclusion criteria for participation in the study included a gestational 
period of 24 to 34 weeks, a diagnosis of GDM, an age of 18 years or older, and 
voluntary consent to participate in the study, while the exclusion criteria included the 
presence of a psychiatric disease, multiple pregnancy, the risk of preterm labor, 
placenta previa or premature rupture of the membranes, and failure to obtain 
voluntary consent to participate in the study.  
 
Data collection 
 
Data were collected by the first author (both control and intervention group). All data 
were collected with questionnaires conducted through face-to-face structured 
interviews with the data collector.  
 
Primary outcomes: 
• 
Primary outcome of women with GDM was their healthy lifestyle 
behaviours measured on the Health-Promoting Lifestyle Profile II (HPLP-II). 
This scale, developed by Walker et al. (1987) on the basis of Pender's health 
promotion model, measures the health-promoting behaviours associated with a 
health-promoting lifestyle. The scale was revised in 1996 and designated as 
HPLP-II (Walker et al. 1996). Bahar et al. (2008) tested the scale’s validity 
and reliability in Turkish. The Cronbach's alpha internal consistency 
coefficient of the scale was found to be 0.92. Higher scores on the scale 
indicate a higher performance level of the determined health-promoting 
behaviours. The scale consists of 52 items under the six subscales of spiritual 
growth, nutrition, physical activity, health responsibility, interpersonal 
relations and stress management. The lowest and highest possible scores on 
the scale are 52 and 208, respectively. 
 

• 
Center for Epidemiologic Studies Depression Scale (CES-D Scale) 
was used to assess symptoms of depression in women. This short scale, 
developed by Radloff (1977) to measure depressive symptoms, can be 
administered to both the general population and specially selected groups. The 
CES-D consists of 20 items, each item scored between 0 and 3. The total score 
ranges between 0 and 60, and a score of 16 and higher suggests the risk of 
depression, while lower scores on the CES-D Scale indicate decreased risks 
for depression. Yilmaz (2010) tested the scale’s validity and reliability in 
Turkish. The Cronbach's alpha value was found to be 0.85 for the entire scale.  
 
• 
Quality of life of the women was measured using the Short Form 36 
Health Survey (SF-36). This scale, developed by Ware in 1987, is globally 
referred to as SF-36, as this acronym has been commonly used in all studies 
since the development of the scale. SF-36 is a self-assessment scale, consisting 
of 36 questions under eight subscales: physical functioning, physical role 
limitation, social functioning, mental health, energy-vitality, bodily pain, 
general health perceptions and emotional role limitation (Ware & Sherbourne 
1992). Pınar (1995) tested the scale’s validity and reliability in Turkish. The 
Cronbach's alpha internal consistency value was found to be 0.91. 
 
• 
Women’s level of knowledge about GDM was measured using pre-test 
and post-test question form. This form, developed by the researcher in 
accordance with the literature, includes questions about GDM and healthy 
lifestyle.  
 
Secondary outcomes 
• 
Postpartum diabetes control of women with GDM was assessed 
through the postpartum 6th week information form that developed by the 
researchers on the basis of the literature. 
 
• 
Postpartum characteristics of neonates were assessed through the 
neonate’s information form that developed by the researchers on the basis of 
the literature. 

The flowchart of this study is shown in Figure 1. 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. 
The women in the both group were administered the introductory information form, 
the HPLP-II, the CES-D and the 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).  
Validity and reliability 
Women with GDM in the intervention and control group were divided into groups by 
randomization method. Women with GDM who were followed up in the perinatology 
clinic were divided into groups by means of a lottery method. In the clinic, women in 

the same room were not taken to different groups to avoid problems among GDM 
women. 
 
In this study reliability of the instruments was measured with Cronbach’s 
alpha. The Cronbach’s alpha value of the HPLP II was 0.90; the CES-D was 0.85 and 
the SF-36 was 0.85.  
Ethical considerations 
The required permissions were obtained from the Clinic Research Ethics Committee 
of Zeynep Kamil Women and Children Diseases Education and Research Hospital. 
All participants gave informed consent prior to inclusion in the study. Participants 
were informed that they could leave the study if they wanted. All contact numbers 
were given to the participants for any inquiries. 
 
Data analysis 
The data were analysed using the SPSS 21 package. The introductory information 
derived from the introductory form administered to the participants in the intervention 
and the control group were analysed using descriptive statistical methods and 
compared using the Chi-square (𝜒2) test and Mann-Whitney test. Pre-post test results 
of women in the intervention group were compared using the Wilcoxon Signed Rank 
Test. The first, second and third assessments of the intervention group were compared 
using the Wilcoxon Signed Rank Test, while the first and third (postpartum 6th 
month) assessments of the intervention and the control groups were compared using 
the Mann-Whitney test. Postpartum characteristics of the neonates were analysed 
using the Chi-square (𝜒2) test and Mann-Whitney test. Lastly, the postpartum diabetes 
controls of the intervention and control groups were compared using Fisher’s exact 
chi-square test.  
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 1. Flowchart of this study 
  Women with GDM in the Perinatology Service (N=350) 
Determination of the number of women with GDM (Power and Sample Size Program) 
The Inclusion Criteria 
- A gestational week of 24 to 34 
- Having a diagnosis of GDM    
- Voluntary participation in the study     
The Exclusion Criteria 
- Having a psychiatric disease 
- Having the risk of preterm labor, premature rupture of membranes, placenta previa etc. 
- Non-consent to voluntarily participate in the study 
Obtaining of the informed consent of the women with GDM 
Allocation of the women with GDM into groups using the randomization method (drawing of lots) 
Intervention group first assessment (n=50) 
- 
Introductory Information Form      
- 
HPLP II 
- 
SF-36 
- 
CES-D                                                                      
Control group first assessment (n=50) 
- 
Introductory Information Form      
- 
HPLP II 
- 
SF-36 
- 
CES-D                                                            
Intervention group (n=50) 
Health-Promoting Lifestyle Education Program 
(HPLEP) + Institution's GDM follow-up policy  
Control group (n=50) 
- 
HPLEP not provided 
- 
Institution's GDM follow-up policy  
Intervention group second assessment  
(4 weeks after receiving the education)                  
- 
HPLP II 
- 
SF-36 
- 
CES-D                                                                  
Control group 
- 
No second assessment 
Intervention group third assessment (postpartum 6th week)     
- 
HPLP II  
- 
SF-36 
- 
CES-D    
(Dropped from the intervention group (n=4): 1 preterm delivery,        
1 change of contact information, 2 withdrawal from the education 
program) 
Control group (In the postpartum 6th week) 
- 
HPLP II 
- 
SF-36 
- 
CES-D       
(Dropped from the control group (n=8): 2 preterm deliveries 
2 change of contact information, 4 withdrawal from the study)           
Intervention group (n=46) 
Control group (n=42) 
Assessment of the Results 
Follow-up via phone (after 2 weeks) 
Follow-up via phone (postpartum)