SFEE Diet Management for Gestational Diabetes Mellitus (SFEE)

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

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).

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes Mellitus (GDM)
• Intervention / Treatment: Behavioral: SFEE Diet Management Intervention; Behavioral: Standard Dietary Advice

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanxi
    • Taiyuan, Shanxi, China, 030001
      • The First Hospital of Shanxi Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Active Comparator: 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.	Behavioral: Standard Dietary Advice; Routine nursing care, including dietary education, exercise planning, and self-monitoring for gestational diabetes management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic Control (Fasting Blood Glucose Levels)	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.	Baseline and 3 months post-intervention
Glycemic Control (HbA1c Levels)	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.	Baseline and 3 months post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary Adherence	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.	Baseline and 3 months post-intervention
GDM Knowledge	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.	Baseline and 3 months post-intervention
Perceived Social Support	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.	Baseline and 3 months post-intervention

Collaborators and Investigators

• Sponsor: Ji Jing
• Investigators: Principal Investigator: Li Jun, Doctorate, The First Affiliated Hospital of Shanxi Medical University

Publications and helpful links

Helpful Links

• First Hospital of Shanxi Medical University Research

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): March 1, 2024
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: November 23, 2024
• First Submitted That Met QC Criteria: November 26, 2024
• First Posted (Estimated): November 27, 2024

Study Record Updates

• Last Update Posted (Estimated): November 27, 2024
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Gestational Diabetes Mellitus, SFEE Diet Management, Glycemic Control, Maternal Outcomes, Dietary Adherence
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Pregnancy Complications; Glucose Metabolism Disorders; Diabetes, Gestational; Diabetes Mellitus
• Other Study ID Numbers: FirstShanxiMU2023; 2022-K205 (Other Identifier: Ethics Committee of the First Affiliated Hospital of Shanxi Medical University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared as there is no provision for data sharing in the current study design, and ethical approval for data sharing has not been obtained. Researchers requiring data can contact the corresponding author for potential collaboration or data access requests in compliance with institutional and ethical guidelines

Study Data/Documents

1. Study Protocol
   Information identifier: 2022-K205
   Information comments: The study protocol includes detailed methods, intervention description, and outcome measures. It is available upon reasonable request from the corresponding author.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No