Clinical trial NCT06707064: SFEE Diet Management for Gestational Diabetes Mellitus
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes Mellitus (GDM)
Keywords: Gestational Diabetes Mellitus, SFEE Diet Management, Glycemic Control, Maternal Outcomes, Dietary Adherence
Lead sponsor: The First Affiliated Hospital of Shanxi Medical University
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were assigned to either the SFEE intervention group or a control group receiving standard dietary advice in a 1:1 allocation ratio.
Primary purpose: TREATMENT

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)

Eligibility criteria: 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).

Primary outcomes:
measure: Glycemic Control (Fasting Blood Glucose Levels)
timeFrame: Baseline and 3 months post-intervention
measure: Glycemic Control (HbA1c Levels)
timeFrame: Baseline and 3 months post-intervention
Secondary outcomes:
measure: Dietary Adherence
timeFrame: Baseline and 3 months post-intervention
measure: GDM Knowledge
timeFrame: Baseline and 3 months post-intervention
measure: Perceived Social Support
timeFrame: Baseline and 3 months post-intervention
Other outcomes:
Locations:
city: Taiyuan
country: China
facility: The First Hospital of Shanxi Medical University
state: Shanxi
Study officials:
affiliation: The First Affiliated Hospital of Shanxi Medical University
name: Li Jun, Doctorate
role: PRINCIPAL_INVESTIGATOR
References: