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).
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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
64
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.
Routine nursing care, including dietary education, exercise planning, and self-monitoring for gestational diabetes management.
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Glycemic Control (Fasting Blood Glucose Levels)
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.
Time frame: Baseline and 3 months post-intervention
Glycemic Control (HbA1c Levels)
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.
Time frame: Baseline and 3 months post-intervention
Dietary Adherence
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.
Time frame: Baseline and 3 months post-intervention
GDM Knowledge
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.
Time frame: Baseline and 3 months post-intervention
Perceived Social Support
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.
Time frame: Baseline and 3 months post-intervention
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