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NCT Number: NCT06707064

SFEE Diet Management for Gestational Diabetes Mellitus

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).

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Key information

Conditions

Gestational Diabetes Mellitus (GDM) Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The First Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Standard Dietary Advice

Behavioral

Routine nursing care, including dietary education, exercise planning, and self-monitoring for gestational diabetes management.

Primary outcomes

  1. Glycemic Control (Fasting Blood Glucose Levels)

    Time frame: 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.

  2. Glycemic Control (HbA1c Levels)

    Time frame: 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 outcomes

  1. Dietary Adherence

    Time frame: 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.

  2. GDM Knowledge

    Time frame: 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.

  3. Perceived Social Support

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ji Jing

Other

Registry information

Official study 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

Acronym: SFEE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 27, 2024
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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