Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
64 participants
INTERVENTIONAL
2023-03-01
2024-03-31
Brief Summary
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Detailed Description
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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)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
SFEE 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.
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.
Standard Dietary Advice
Routine nursing care, including dietary education, exercise planning, and self-monitoring for gestational diabetes management.
Interventions
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SFEE 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.
Standard Dietary Advice
Routine nursing care, including dietary education, exercise planning, and self-monitoring for gestational diabetes management.
Eligibility Criteria
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Inclusion 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
* 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).
18 Years
45 Years
FEMALE
No
Sponsors
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Ji Jing
OTHER
Responsible Party
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Ji Jing
Head of Nurse Department
Principal Investigators
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Li Jun, Doctorate
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Shanxi Medical University
Locations
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The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Countries
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Study Documents
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Document Type: Study Protocol
The study protocol includes detailed methods, intervention description, and outcome measures. It is available upon reasonable request from the corresponding author.
View DocumentRelated Links
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First Hospital of Shanxi Medical University Research
Other Identifiers
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2022-K205
Identifier Type: OTHER
Identifier Source: secondary_id
FirstShanxiMU2023
Identifier Type: -
Identifier Source: org_study_id