The effect of a health literacy approach to counselling on the lifestyle of women with gestational diabetes: A clinical trial

Background: Gestational diabetes is a common pregnancy disorder that affects the mother’s and neonate’s health. The present study was conducted to investigate the effect of a health literacy approach to counselling on the lifestyle of women with gestational diabetes. The present randomized controlled clinical trial was conducted in 2017 using a parallel design. The subjects included 84 eligible women presenting to Alborz and Kamali Hospitals, Karaj, Iran. Methods: Convenience sampling was first used to select the subjects. They were then assigned to an intervention or control group based on randomized blocks of four. Both groups attended counselling sessions. The mothers in the intervention group attended six sessions of counselling with a health literacy approach in addition to counselling on routine pregnancy care. The control group attended counselling sessions on safe pregnancy care and received a training package containing all the subjects discussed in the intervention group. The Lifestyle Questionnaire and the Iranian Health Literacy Questionnaire were completed by the mothers at the beginning and at the end of the sessions as well as three weeks after the sessions. The data obtained were analyzed in SPSS-19. Results: According to the study findings, the scores of lifestyle (P=0.8) and health literacy (P=0.423) showed no significant differences between the intervention and control groups before the intervention. Significant differences were, however, observed in the mean scores of lifestyle and health literacy between the two groups immediately and three weeks after the intervention. Comparing the means showed a higher increase in the mean scores in the intervention group (P<0.001). Conclusions: Providing counselling services by midwives can significantly help modify mothers’ unhealthy lifestyle choices and increase their health literacy; therefore, reducing maternal and neonatal consequences, especially in high-risk pregnancies. Trial registration number: IRCT2017021427728N3 Trial registry: Iranian Registry of Clinical Trials Trial registration date: 5th April 2017


Introduction
Although pregnancy is a normal physiologic phenomenon, it can deviate from its normal path and cause disability, or even maternal and fetal mortality 1 . Gestational diabetes is a major disorder that causes numerous complications in the mother and her baby. Gestational diabetes is a metabolic disorder that emerges or is diagnosed for the first time with carbohydrate intolerance during pregnancy and is considered the most common gestational complication 2 . The prevalence of gestational diabetes differs in different regions, which can be explained by factors, such as ethnic diversity, differences in lifestyle and nutrition and different screening protocols 3 . This disease influences maternal and fetal health and causes the emergence of numerous undesirable outcomes 4 . These complications include hypertension, preeclampsia, urinary tract infections, hydramnios, surgical interventions, the risk of developing type 2 diabetes in mothers in the future, and macrosomia followed by an increased risk of birth trauma, congenital anomalies, childhood obesity and growth disorders in neonates 5 .
Many factors are associated with gestational diabetes, including social determinants of health 6 . Lifestyle is one of the main factors that can play a key role in preventing or treating gestational diabetes. Research suggests serious relationships between developing diabetes and lifestyle risk factors, such as smoking, inappropriate nutrition, drinking, obesity and limited physical activity 7,8 . Nowadays, more than 70% of diseases are believed to be somewhat related to people's lifestyle and many illnesses appear to be directly or indirectly caused by lifestyle or at least be exacerbated or sustained by lifestyle 9,10 . Gestational diabetes prevention strategies have recently focused on promoting healthy lifestyles in patients by encouraging physical activity and promoting healthy nutrition 11 . Nevertheless, modifying lifestyle requires adequate information in this regard 12 . In fact, the decisions made by people and their performance regarding lifestyle behaviors depends on their level of literacy, which exerts a key effect on preventing and controlling chronic diseases such as diabetes 13 . Today, health literacy improves health behaviors, creates a healthy lifestyle and promotes the quality of life 14-16 . Health literacy refers to one's capacity for acquiring, interpreting and understanding primary health information and services required for proper health decision making 17 . Enhancing the awareness and preparedness during pregnancy helps the mother pass this stage of life with fewer complications. As a result, pregnancy provides a good opportunity for teaching and counseling pregnant women and making them aware of the advantages of having a healthy lifestyle 18 . Given the importance of pregnant women as a vulnerable social class, the fifth goal of United Nations Millennium Development Goals, i.e. a 75% reduction in maternal mortality through improving mothers' health 19 , and the significance of gestational diabetes as the most common pregnancy complication and a threat to the mother's and baby's health, the present study was performed to examine the effect of a health literacy approach to counselling on the lifestyle of women with high-risk pregnancy and gestational diabetes.

Methods
The present randomized controlled clinical trial was conducted using a parallel design. The study population comprised pregnant women with gestational diabetes presenting to Alborz and Kamali hospitals in Karaj, Iran in April 2017.

Subjects
Inclusion criteria: The eligible candidates comprised 18-35-yearold Iranian women with gestational diabetes, whose disease was first diagnosed using the FBS, OGTT or GCT tests, as per the criteria of the World Health Organization 20 . The exclusion criteria consisted of being absent from, at most, two counseling sessions, having other physical or mental co-morbidities, such as cardiac, renal and thyroid disorders, and unwillingness to participate in the study.
After going to prenatal clinics of Alborz and Kamali Hospitals for routine check-ups, the researcher (MG) identified eligible mothers and explained the study objectives to them and asked them to sign an informed consent form if they were willing to participate. Convenience sampling was first used to select the subjects. They were then assigned to the intervention and control groups based on randomized blocks of four. Each "block" had a specified number of randomly ordered treatment assignments.

Sample size calculation
Based on the formula for calculating the difference between two ratios and given a probability of proper lifestyle in 10% of the subjects in the intervention group (with gestational diabetes) and its improvement to 30%, the sample size was calculated as 84, i.e. n=42 in each group. 2 1 α=5 % β=20 % P1=10% P 2=3% n1/n2=1 n=42

Intervention
The intervention group received counselling on routine pregnancy care and a health literacy approach to counselling for modifying lifestyle. The control group received counselling on routine pregnancy care as per the safe national maternal protocol of Ministry of Health and Medical Education of Iran as well as a training package containing all the subjects discussed in the intervention group. The sessions were taken by MG, MT. More information about the training sessions are included in Supplementary File 2.
Both groups attended six 1.5-hour sessions, once a week. To prevent cross talk by participants, the counselling sessions for the control and intervention groups were held on different days. The researcher followed up the mothers by phone.
The content of sessions in the intervention group was presented using a health literacy approach according to the protocol for the care of mothers with gestational diabetes approved by Ministry of Health and Medical Education of Iran as follows: Session one: Introducing the members of the group to one another and the group leader, establishing a positive relationship, stating the group rules and creating motivations for the active participation and timely attendance in the sessions, explaining gestational diabetes and attitudes towards it and the role of a proper lifestyle in coping with gestational diabetes.

Session two:
Counselling on self-awareness skills, understanding the status quo, explaining the suffering and difficulties they experienced, introducing and learning how to use insulin, injection-associated problems, attitudes towards insulin treatment and the ways of coping with these attitudes and illustrating a favorable status.
Session three: Counselling on health-related skills, including understanding basic information about nutrition, essential diets, understanding the effects of nutrition on improving the status, understanding basic information about physical exercise and its effects on improving maternal and fetal status, and explaining the capacity of performing exercises and the types of exercise allowed during pregnancy.
Session four: Counselling on the concepts associated with emotional skills, including understanding the fear and stress caused by the effect of the disease on the fetus and the body, the subject's appearance and the disease survival after pregnancy and the ways of coping with it.
Session five: Understanding and counselling on the concepts associated with communication skills, understanding the effect of family and social supports, comprehending basic information about incorrect health behaviors and their effects on the mother and the fetus, understanding the effect of the support provided by the spouse, family and society on these behaviors and introducing services associated with pregnancy and screening.
Session six: Summarizing the presented subjects, practicing the counseled skills, responding to questions and receiving feedback on the classes held.
At the beginning, the end and three weeks after the sessions, Iranian Health Literacy Questionnaire (IHLQ) and Lifestyle Questionnaire (LSQ) were distributed among both groups and they were asked to complete them. If the patient was illiterate, the researcher completed the questionnaire by an interview.

Data collection
The data collection tools comprised the IHLQ, the LSQ and a sociodemographic checklist (Supplementary File 3).
The 53-item IHLQ contains 9 subscales, including access to health information access, health information use, reading skills, comprehension skills, assessment and judgment skills, decision-making

Data analysis
The data collected were analyzed in SPSS-19 using independent ttest, Mann-Whitney test, Fisher's exact test and Chi-square test.

Results
A total of 100 subjects were initially recruited, and 16 were excluded during the study: 8 subjects were excluded in the intervention group, including 2 for failing to complete the questionnaires, 4 for being absent for more than two sessions, and 2 for preterm delivery at a 25-week and 29-week gestational age; 8 subjects were also excluded from the control group, including 4 for failing to complete the questionnaires, 3 for failing to attend the sessions and 1 for abortion at 16 weeks of pregnancy. Therefore, the study ended with 84 subjects (Figure 1).
The present study investigated 84 mothers with gestational diabetes in two groups, who were examined until the end of the study. After examining the normality of the study variables, no significant differences were observed between the two groups in terms of mean age, level of education, body mass index (BMI), occupational status and gestational age, and the two groups were therefore matched in terms of the cited variables (Table 1).
According to the study findings, no significant differences were observed between the two groups in terms of the mean score of lifestyle before the intervention. Therefore, the two groups were matched before the intervention in terms of lifestyle. The two groups exhibited significant differences in the mean score of lifestyle after the intervention. This mean score showed a significant increase immediately and three weeks after the intervention, and this increase was higher in the intervention group (Table 2).
No significant differences were observed between the two groups in terms of the mean score of health literacy before the intervention, and the two groups were therefore matched in this regard. The two groups exhibited significant differences in the mean score of health literacy immediately and three weeks after the intervention, and this increase was significant in the intervention group (Table 3).  *P-values are comparing the difference in scores of lifestyle in three phases, before, immediately after and 3 weeks after intervention, between the intervention and the control groups.

Health literacy Before intervention After intervention 3 weeks after intervention
Intervention group 9.95±2.52 14.44±1.29 13.17±1.77 F=278.69 P<0.001* Control group 10.36±2.14 11.66±1.89 11.34±1.98 *P-value is comparing the difference in scores of health literacy in three phases, before, immediately after and 3 weeks after intervention, between the intervention and the control groups.

Discussion
Gestational diabetes is a common disorder during pregnancy, which can negatively affect prenatal outcomes and is associated with lifestyle risk factors. Modern prevention methods of gestational diabetes emphasize modifying lifestyle risk factors 18,22 .
The present study findings suggest no significant differences between the two groups before counselling in terms of the score of lifestyle. In other words, the two groups presented the same level of lifestyle upon entering the study; however, immediately after and three weeks after the intervention, a higher increase was observed in the mean scores of variables, such as physical health, sports and fitness, weight management and nutrition, disease prevention, mental health, avoidance of drugs, alcohol and opiates, accident prevention and the overall lifestyle of the mothers, in the intervention group compared to those in the control group, although no significant differences were observed between the two groups in spiritual health and environmental health. Before the intervention, no significant differences were observed between the two groups in the score of health literacy, and the two groups were matched in terms of the level of health literacy. The mean score of health literacy, however, showed a higher increase immediately and three weeks after the intervention in the intervention group compared to that in the controls. Given that the two groups were matched in terms of demographic characteristics and level of health literacy, the findings suggest the effect and role of counseling and the counselor midwife in improving the level of health literacy in mothers with gestational diabetes. This finding is consistent with the results of the studies conducted by Tol et al. 28 and Kandula et al. 29 . These researchers found that education and counselling increase the score of health literacy in diabetics with any levels of health literacy. Luoto et al. reported that interventions at the level of patient communication skills can improve the awareness, literacy and clinical indicators of diabetics 23 . Today, many health problems and human social needs can be solved using advisors as facilitators for knowledge based on useful relationships. 30 .
The strength of the present study was the fact that the intervention and control groups matched in terms of some confounding demographic variables affecting the results, including age, level of education, BMI and gestational age, and the results obtained were not therefore affected by these variables. The researchers made efforts to use random allocation and match the subjects in both groups; however, the subjects' lifestyle was impossible to be completely controlled and this was a limitation of the present research.

Conclusion
The findings obtained from the present research showed that both routine pregnancy counselling and a health literacy approach to counselling causes an increase in the overall score of lifestyle and health literacy. As members of the health system and the main supervisors of pregnant women, midwives have the closest relationship with these women and are in charge of providing them with care services and necessary recommendations during pregnancy. They can therefore take more effective steps towards improving mothers' health and pregnancy outcomes by applying correct counselling principles for resolving mothers' problems.

Ethical statement
The present research was approved by the Ethics Committee of Alborz University of Medical Sciences and Health Services on 4 March 2017 (Abzums.Rec.1395.146). Written informed consent was obtained from all subjects for participation in the study.

Data availability
Dataset 1: Sociodemographic characteristics, and results from the IHLQ and LSQ questionnaires, before, immediately after and 3 weeks after intervention for control and intervention groups. DOI, 10.5256/f1000research.13838.d195054 31

Competing interests
No competing interests were disclosed.

Grant information
The author(s) declared that no grants were involved in funding this work.

Supplementary material
Supplementary The problem statements agreed with the title and seemed to be significance. Several appropriate references were used in the introduction section, but the literature was not clearly visible to the reader, and it required several conflicting findings about the effect of Health literacy on life style.
The aim of this study is clearly stated, however, it is better to remove "high risk pregnancy "in the last sentences of the introduction section.
In methodology section, the instruments were explained, and their reliability and validity were stated. The population used was adequate. The counselling sessions were explained clearly. It is better to clarify the number of participants in intervention and control groups from each hospital. The statistical techniques were stated but no discussion was given in this particular section.
In the results section, the findings were presented by appropriate figure and tables according to aim of the study.
In the discussion section, the findings of other studies supported the results of the present study but the conflicting findings were not stated.
The conclusion section was stated clearly that included summary of the main findings and recommendation but the recommendation for further researches was not given.
In the Socio Demographic check list it was better "weight gain" written instead of increase weight.

Shirin Djalalinia
Noncommunicable Diseases Research Center, Endocrinology and Metabolism Population Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran Gharachourlo et al performed an interesting clinical trial about the effect of a health literacy approach to counselling on the lifestyle of women with gestational diabetes, enrolled 42 eligible 18-35-yearold Iranian women with gestational diabetes in each groups. They concluded that providing counselling services by midwives can significantly promote the lifestyle patterns and increase their health literacy, especially in high-risk pregnancies.
The field of gestational diabetes consider as one of the most important priorities of maternal health and designing and development of the manuscript are interesting.
I think the paper may therefore be suitable for publication after some minor changes that I suggested below: Please rename 'subjects' to 'participant'. In the Introduction section; please provide the gap of related evidence and briefly point to justification of conduction of present study in these regards. In the Methods section; refer to your approaches in data analyzing even used soft wares. The strengths aspects of investigation could be discussed in more details. Further subjects could be providing for more complementary researches in related domains.

Is the work clearly and accurately presented and does it cite the current literature? Yes
Is the study design appropriate and is the work technically sound? Yes

If applicable, is the statistical analysis and its interpretation appropriate? Yes
Are all the source data underlying the results available to ensure full reproducibility? Yes

Are the conclusions drawn adequately supported by the results? Partly
No competing interests were disclosed.

Competing Interests:
I have read this submission. I believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.