A Parallel-Group Controlled Clinical Study to Evaluate the Efficacy of Self-Family-Environment Empowerment (SFEE) Diet Management Intervention in Improving Outcomes for Pregnant Women With Gestational Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Glycemic Control (HbA1c Levels)
研究概览
简要总结
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).
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
SFEE Diet Management Group ( Experimental Arm)
Participants in this group received the Self-Family-Environment Empowerment (SFEE) diet management intervention, which included:
Self-empowerment: Goal-setting, dietary planning, and evaluation. Family empowerment: Emotional support and supervision of dietary practices. Environmental empowerment: Peer group interaction, education, and support through WeChat groups.
Routine nursing care was also provided alongside the intervention.
干预措施: SFEE Diet Management Intervention (Behavioral)
Control Group
Participants in this group received routine nursing care for gestational diabetes management, including:
Medication guidance, dietary education using guidance charts, exercise plans, and self-monitoring.
Dietary plans were customized based on individual patient needs, but no additional empowerment strategies (e.g., SFEE) were implemented.
干预措施: Standard Dietary Advice (Behavioral)
结局指标
主要结局
Glycemic Control (HbA1c Levels)
时间窗: 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.
Glycemic Control (Fasting Blood Glucose Levels)
时间窗: 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.
次要结局
- GDM Knowledge(Baseline and 3 months post-intervention)
- Dietary Adherence(Baseline and 3 months post-intervention)
- Perceived Social Support(Baseline and 3 months post-intervention)
研究者
Ji Jing
Head of Nurse Department
The First Affiliated Hospital of Shanxi Medical University