Gestational Diabetes Mellitus (GDM)SFEENCT06707064
SFEE Diet Management for Gestational Diabetes Mellitus
A study testing SFEE Diet Management Intervention and Standard Dietary Advice in people with Gestational Diabetes Mellitus (GDM), run by Ji Jing at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus (GDM)
- What is being tested?
- SFEE Diet Management Intervention and Standard Dietary Advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
About this study
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
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).
Read the 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)
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Being tested
- SFEE Diet Management Intervention, Standard Dietary Advice
- Keywords
- Gestational Diabetes Mellitus, SFEE Diet Management, Glycemic Control, Maternal Outcomes, Dietary Adherence
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SFEE Diet Management InterventionBehavioural
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 AdviceBehavioural
Routine nursing care, including dietary education, exercise planning, and self-monitoring for gestational diabetes management.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard Dietary Advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 3 months post-intervention
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline and 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start1 Mar 2023
- Primary completion1 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus (GDM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ji Jing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ji Jing, The First Affiliated Hospital of Shanxi Medical University
- Investigators
- Li Jun, Doctorate, Principal investigator, The First Affiliated Hospital of Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707064
- Sponsor's protocol ID
- FirstShanxiMU2023
- Other IDs
- 2022-K205
- Acronym
- SFEE
- Status last verified
- Nov 2024
- First submitted
- 23 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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 at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06707064
- Acronym / sponsor ID
- SFEE / FirstShanxiMU2023
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Keywords
- Gestational Diabetes Mellitus, SFEE Diet Management, Glycemic Control, Maternal Outcomes, Dietary Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Ji JingUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 27 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| SFEE Diet Management Group ( Experimental Arm) | Experimental | Behavioral: SFEE Diet Management InterventionParticipants 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. |
| Control Group | Active comparator | Behavioral: Standard Dietary AdviceParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SFEE Diet Management InterventionA 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. | Behavioural | SFEE Diet Management Group ( Experimental Arm) |
| Standard Dietary AdviceRoutine nursing care, including dietary education, exercise planning, and self-monitoring for gestational diabetes management. | Behavioural | Control Group |
Primary outcome
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.
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.
3 secondary outcomes
Dietary Adherence
Time frame: Baseline and 3 months post-intervention
GDM Knowledge
Time frame: Baseline and 3 months post-intervention
Perceived Social Support
Time frame: Baseline and 3 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- First Hospital of Shanxi Medical University ResearchLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Jun, Doctorate principal investigator
The First Affiliated Hospital of Shanxi Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SFEE Diet Management Intervention and Standard Dietary Advice in people with Gestational Diabetes Mellitus (GDM), run by Ji Jing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic Control (Fasting Blood Glucose Levels) (time frame: Baseline and 3 months post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.