SFEE Diet Management for Gestational Diabetes Mellitus

Ji Jing

Status: Completed

Conditions: Gestational Diabetes Mellitus (GDM)

Treatments: Behavioral: SFEE Diet Management Intervention; Behavioral: Standard Dietary Advice

Study type: Interventional

Funder types: Other

Identifiers

NCT06707064

FirstShanxiMU2023

2022-K205 (Other Identifier)

Details and patient eligibility

About

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).

Full 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)

Enrollment: 64 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups

SFEE Diet Management Group ( Experimental Arm)

Experimental group

Description:

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.

Treatment:

Behavioral: SFEE Diet Management Intervention

Control Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard Dietary Advice