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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-K205 | Other Identifier | Ethics Committee of the First Affiliated Hospital of Shanxi Medical University |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SFEE Diet Management Group ( Experimental Arm) | Experimental | 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. |
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| Control Group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SFEE Diet Management Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline and 3 months post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 3 months post-intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Li Jun, Doctorate | The First Affiliated Hospital of Shanxi Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Shanxi Medical University | Taiyuan | Shanxi | 030001 | China |
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| Label | URL |
|---|---|
| First Hospital of Shanxi Medical University Research | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 2022-K205 | Study Protocol | View IPD |
Individual participant data (IPD) will not be shared as there is no provision for data sharing in the current study design, and ethical approval for data sharing has not been obtained. Researchers requiring data can contact the corresponding author for potential collaboration or data access requests in compliance with institutional and ethical guidelines
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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Participants were assigned to either the SFEE intervention group or a control group receiving standard dietary advice in a 1:1 allocation ratio.
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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.
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| Standard Dietary Advice | Behavioral | Routine nursing care, including dietary education, exercise planning, and self-monitoring for gestational diabetes management. |
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| 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. |
| 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. | Baseline and 3 months post-intervention |
The study protocol includes detailed methods, intervention description, and outcome measures. It is available upon reasonable request from the corresponding author. |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |