SFEE Diet Management for Gestational Diabetes Mellitus

NCT06707064 | Completed

• 2 other identifiers: FirstShanxiMU20232022-K205
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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).

Conditions

Gestational Diabetes Mellitus (GDM)

Keywords

Gestational Diabetes Mellitus, SFEE Diet Management, Glycemic Control, Maternal Outcomes, Dietary Adherence

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Dietary Adherence

  Baseline and 3 months post-intervention

• GDM Knowledge

  Baseline and 3 months post-intervention

• Perceived Social Support

  Baseline and 3 months post-intervention

Study Arms (2)

SFEE Diet Management Group ( Experimental Arm)

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Interventions

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.

SFEE Diet Management Group ( Experimental Arm)

Standard Dietary Advice BEHAVIORAL

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

Control Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ji Jing: lead

Study Sites (1)

The First Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

Location

Related Links

• First Hospital of Shanxi Medical University Research

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Li Jun, Doctorate

  The First Affiliated Hospital of Shanxi Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors were blinded to minimize bias during data collection and analysis. Participants and care providers were not masked due to the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Nurse Department

Model Details: Participants were assigned to either the SFEE intervention group or a control group receiving standard dietary advice in a 1:1 allocation ratio.

Study Record Dates

• First Submitted: November 23, 2024
• First Posted: November 27, 2024
• Study Start: March 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 31, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)