SFEE Diet Management for Gestational Diabetes Mellitus

Not Applicable

Completed

• Conditions: Gestational Diabetes Mellitus (GDM)

• Registration Number: NCT06707064
• Lead Sponsor: Ji Jing

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)

Study Timeline

• Study Start: 2023-03-01
• Primary Completion: 2024-03-01
• Study Completion: 2024-03-31
• Status Verified: 2024-11
• Study First Submitted: 2024-11-23
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study First Posted: 2024-11-27
• Last Update Posted: 2024-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 64

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

The First Hospital of Shanxi Medical University; 🇨🇳 Taiyuan, Shanxi, China