Investigating the effect of non-pharmacological lifestyle modification intervention on self-efficacy, health-promoting lifestyle behaviors, and life satisfaction in women with gestational diabetes: A randomized clinical trial study

Studying the effect of non-pharmacological lifestyle modification intervention on self-efficacy, health-promoting lifestyle behaviors, and life satisfaction in women with gestational diabetes

This study is a randomized controlled clinical trial with a parallel design, single-blinded, conducted in phase II. After meeting the inclusion criteria, participants were randomly assigned to either the intervention or control group using block randomization with variable block sizes (4 and 6). The total sample size was 60 participants (30 in each group). The random sequence was generated using SPSS software, and allocation concealment was ensured through the use of sealed, opaque envelopes.

This study will be conducted in Kowsar hospitals in Qazvin. Before implementing the intervention, the level of self-efficacy, health-promoting lifestyle behaviors, and life satisfaction will be assessed. Then, the intervention will be carried out in the intervention group, and immediately after the end of the intervention, and again 3 months after the intervention, the questionnaires will be completed again in both groups.

Inclusion: confirmed gestational diabetes, 24–28 weeks gestation, age 18–40, literate, informed consent, access to communication, local residency. Exclusion: chronic debilitating diseases, severe psychiatric history, use of psychotropic or lifestyle-affecting drugs, participation in other interventions.

The intervention consisted of a lifestyle modification program in the areas of nutrition, physical activity, stress management, sleep, and social support, which was implemented in person and virtually over a period of 6 weeks. The control group received only routine prenatal care.

Self-efficacy, health-promoting lifestyle behaviors, and life satisfaction

In this study, a block randomization method with variable block sizes (4 and 6) was used to maintain a uniform distribution of participants in the two intervention and control groups. The randomization unit was the individual; each participant was independently assigned to one of the two groups. Stratified randomization was used to increase the balance between the groups in terms of age (under 30 years and 30 years and older) and education level (diploma and below, higher than diploma). The random sequence generation tool was SPSS statistical software version 26, which was implemented by an independent researcher (not involved in the data collection process or analysis of the results). The random sequence was first generated completely by the software and then the group allocation was concealed using serial numbering and opaque, unpredictable, and sealed envelopes. Allocation concealment was performed in such a way that the person responsible for registering and entering participants into the study was not aware of the allocation sequence, and the envelopes were opened sequentially only when the participant entered and confirmed the entry conditions.

This study is a single-blind clinical trial. Therefore, blinding will be implemented in the assessors who will analyze the study data. For this purpose, the questionnaires that will be completed by the researchers in all two groups will be identified by an agreement between the researchers with one of the English letters at the top, indicating which of the study groups the questionnaire was completed by the participants; however, the assessors analyzing the data will not be aware of the agreement between the researchers that has been assigned to each group.

Only a portion of the data, such as information related to the main outcome and general demographic information, can be shared.

Access period starts 3 months after results are published.

Doctors, nurses, midwives, researchers working in universities, medical centers and hospitals, clinical psychologists

For use for scientific purposes, with reference to the source used and request for the journal in which the article will be published.

Communication via email (if sharing information is legally and ethically possible, such as sharing the primary outcome of the study) To receive information, contact the following email address: Corresponding author's email: leiladehghankar66@gmail.com

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