Gestational Diabetes Mellitus (GDM)
Conditions
Keywords
Gestational Diabetes Mellitus, SFEE Diet Management, Glycemic Control, Maternal Outcomes, Dietary Adherence
Brief summary
This study aims to evaluate the impact of the Self-Family-Environment Empowerment (SFEE) diet management intervention on glycemic control, maternal outcomes, and dietary adherence in pregnant women with gestational diabetes mellitus (GDM).
Detailed description
Gestational diabetes mellitus (GDM) is a common complication of pregnancy, posing risks to maternal and fetal health. Effective management of GDM is critical to improving outcomes. This study aims to evaluate the potential of the Self-Family-Environment Empowerment (SFEE) diet management intervention in empowering pregnant women with GDM to improve glycemic control, dietary adherence, and maternal outcomes. The study is conducted as a parallel-group controlled trial at the First Affiliated Hospital of Shanxi Medical University. Participants are allocated to two groups: an intervention group receiving routine care combined with the SFEE program and a control group receiving routine care only. The SFEE intervention integrates self-management strategies, family empowerment, and community learning, designed to support adherence to dietary recommendations and enhance participants' understanding of GDM management. Primary outcomes include fasting blood glucose, postprandial glucose, and HbA1c levels measured after a 3-month intervention. Secondary outcomes include dietary adherence (assessed via a validated scale), GDM knowledge (measured using a questionnaire), and perceived social support (measured using the Perceived Social Support Scale)
Interventions
BEHAVIORALSFEE Diet Management Intervention
A structured diet management program designed to improve glycemic control, dietary adherence, and maternal outcomes. It includes: Self-empowerment: Goal-setting, dietary planning, and evaluation. Family empowerment: Emotional support and supervision. Environmental empowerment: Peer group interaction and education via WeChat groups and in-person meetings.
BEHAVIORALStandard Dietary Advice
Routine nursing care, including dietary education, exercise planning, and self-monitoring for gestational diabetes management.
Sponsors
Ji Jing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors were blinded to minimize bias during data collection and analysis. Participants and care providers were not masked due to the nature of the intervention.
Intervention model description
Participants were assigned to either the SFEE intervention group or a control group receiving standard dietary advice in a 1:1 allocation ratio.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with gestational diabetes mellitus (GDM) based on the International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria. * Aged 18-45 years. * Pregnant women between 24-28 weeks of gestation at the time of enrollment. * Able to provide informed consent. * Access to a mobile phone and internet for study communication and follow-up.
Exclusion criteria
* Pregnant women with complications such as placental abruption, miscarriage, or induced abortion during the study period. * Those unable to give informed consent or adhere to the intervention due to medical or personal reasons. * History of severe medical conditions or other factors that might interfere with study participation (e.g., severe mental health conditions).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic Control (Fasting Blood Glucose Levels) | Baseline and 3 months post-intervention | Change in fasting blood glucose levels (measured in mmol/L) from baseline to the end of the 3-month intervention period. This measure evaluates the effectiveness of the SFEE diet management intervention in improving blood glucose regulation in gestational diabetes mellitus. |
| Glycemic Control (HbA1c Levels) | Baseline and 3 months post-intervention | Change in HbA1c levels (measured in %) from baseline to the end of the 3-month intervention period. This measure assesses the long-term blood sugar control improvements resulting from the SFEE diet management intervention compared to standard dietary advice. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dietary Adherence | Baseline and 3 months post-intervention | Change in dietary adherence scores, measured using a validated adherence scale (range: 13-65, with higher scores indicating better adherence). This measure evaluates the participants' compliance with recommended dietary practices after the intervention. |
| GDM Knowledge | Baseline and 3 months post-intervention | Change in gestational diabetes knowledge scores, measured using a validated questionnaire (range: 0-80, with higher scores indicating greater knowledge). This measure assesses the participants' understanding of gestational diabetes management, including diet and exercise. |
| Perceived Social Support | Baseline and 3 months post-intervention | Change in perceived social support scores, measured using the Perceived Social Support Scale (range: 12-84, with higher scores indicating more support). This measure evaluates the impact of the intervention on participants' perceived emotional and social support. |
Countries
China
Outcome results
None listed