PreDiabetesNCT04256460
Shanghai Community Prediabetes Standardized Management Project
A study testing Healthy diet, regular exercises and peer support in people with PreDiabetes, run by Shanghai 6th People's Hospital at 53 sites in China.
Trial summary
Participants with prediabetes is the key targets for diabetes prevention. So, in order to further strengthen and standardize the management of participants with prediabetes in the communities, the investigators start this project of standardized management of participants with prediabetes in communities of Shanghai. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- PreDiabetes
- What is being tested?
- Healthy diet, regular exercises and peer support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 53 sitesChina
- Study dates
- 1 Dec 2019to 1 Dec 2023
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chinese residents
- Adult age ≥ 18 years old, 35-75 years old preferred
- Participants receiving prediabetes management of the basic public health services package in community health centers
- BMI≥24 kg/m2 or central obesity (Waist circumference≥90 cm in males，Waist circumference≥85 cm in females) or Hypertension (SBP≥140 mmHg and/or DBP≥90 mmHg) preferred
- Signed informed consents and willing to participate
Who cannot join
- With serious chronic diseases, tumors, acute and chronic infectious diseases, limb movement disorders, and any mental illnesses
- Women during pregnancy or breastfeeding
- With excessive drinking or illicit drug use
- Unwilling to participate in the project
- Histories of severe cardiovascular events (myocardial infarction, stroke, acute coronary syndrome, or transient ischemic attack (TIA))
Trial locations and contacts
53 sites in 1 country.
53 sites in 1 country
China53 sites
Anting community health service center
Shanghai, Shanghai Municipality
Baihe community health service center
Shanghai, Shanghai Municipality
Beiwaitan community health service center
Shanghai, Shanghai Municipality
Caoyang community health service center
Shanghai, Shanghai Municipality
Changfeng baiyu community health service center
Shanghai, Shanghai Municipality
Changfeng changfeng community health service center
Shanghai, Shanghai Municipality
Changqiao community health service center
Shanghai, Shanghai Municipality
Changshou community health service center
Shanghai, Shanghai Municipality
Changzhengzhen community health service center
Shanghai, Shanghai Municipality
Chendun community health service center
Shanghai, Shanghai Municipality
Chonggu community health service center
Shanghai, Shanghai Municipality
Dahua community health service center
Shanghai, Shanghai Municipality
Dongjing community health service center
Shanghai, Shanghai Municipality
Fangsong community health service center
Shanghai, Shanghai Municipality
Fenglin community health service center
Shanghai, Shanghai Municipality
Ganquan community health service center
Shanghai, Shanghai Municipality
Hongmei community health service center
Shanghai, Shanghai Municipality
Huamu community health service center
Shanghai, Shanghai Municipality
Huangdu community health service center
Shanghai, Shanghai Municipality
Huinan community health service center
Shanghai, Shanghai Municipality
Jiangwan community health service center
Shanghai, Shanghai Municipality
Jinqiao community health service center
Shanghai, Shanghai Municipality
Jinyang community health service center
Shanghai, Shanghai Municipality
Juyuanxinqu community health service center
Shanghai, Shanghai Municipality
Kangjian community health service center
Shanghai, Shanghai Municipality
Liantang community health service center
Shanghai, Shanghai Municipality
Longhua community health service center
Shanghai, Shanghai Municipality
Luodian community health service center
Shanghai, Shanghai Municipality
Luojing community health service center
Shanghai, Shanghai Municipality
Malu community health service center
Shanghai, Shanghai Municipality
Miaohang community health service center
Shanghai, Shanghai Municipality
Nanjingxi Road community health service center
Shanghai, Shanghai Municipality
Nanxiang community health service center
Shanghai, Shanghai Municipality
Nicheng community health service center
Shanghai, Shanghai Municipality
Puxing community health service center
Shanghai, Shanghai Municipality
Qilian community health service center
Shanghai, Shanghai Municipality
Quyang community health service center
Shanghai, Shanghai Municipality
Sheshan community health service center
Shanghai, Shanghai Municipality
Shiquan community health service center
Shanghai, Shanghai Municipality
Songnan community health service center
Shanghai, Shanghai Municipality
Tangzhen community health service center
Shanghai, Shanghai Municipality
Taopuzhen community health service center
Shanghai, Shanghai Municipality
Taopuzhen No.2 community health service center
Shanghai, Shanghai Municipality
Tianlin community health service center
Shanghai, Shanghai Municipality
Waigang community health service center
Shanghai, Shanghai Municipality
Xianghuaqiao community health service center
Shanghai, Shanghai Municipality
Xiaokunshan community health service center
Shanghai, Shanghai Municipality
Yichuan community health service center
Shanghai, Shanghai Municipality
Yuepu community health service center
Shanghai, Shanghai Municipality
Zhaoxiang community health service center
Shanghai, Shanghai Municipality
Zhenruzhen community health service center
Shanghai, Shanghai Municipality
Zhongshan community health service center
Shanghai, Shanghai Municipality
Zhujiajiao community health service center
Shanghai, Shanghai Municipality
About this study
Participants with prediabetes is the key targets for diabetes prevention. So, in order to further strengthen and standardize the management of participants with prediabetes in the communities, the investigators start this project of standardized management of participants with prediabetes in communities of Shanghai. Explore the standardized management model for prediabetes participants within primary healthcare settings in Shanghai, to reduce the risk factors of diabetes, improve the blood glucose control, and the quality of life of participants with prediabetes.
Read the detailed description
Participants with prediabetes is the key targets for diabetes prevention. So, in order to further strengthen and standardize the management of participants with prediabetes in the communities, the investigators start this project of standardized management of participants with prediabetes in communities of Shanghai. Explore the standardized management model for prediabetes participants within primary healthcare settings in Shanghai, to reduce the risk factors of diabetes, improve the blood glucose control, and the quality of life of participants with prediabetes.
Through the collaboration the Shanghai Municipal Center for Disease Control \& Prevention network, this investigators will implement prediabetes screening and lifestyle intervention in around 50 community health service centers in Shanghai. Life-style interventions including exercise and diet, and diabetes prevention knowledge will be integrated into "train-the-trainers" workshops. Trainings will be provided to community health service staff and peer supporters or social workers.
- Conditions
- PreDiabetes
- Being tested
- Healthy diet, regular exercises and peer support
- Keywords
- prediabetes, life style intervention, peer support, self management support, primary healthcare, community
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy diet, regular exercises and peer supportBehavioural
After assessing the exercise and nutritional status of the participants, health staff in community health centers implemented personalized healthy diet and regular exercises intervention, including coaching on healthy exercises and developing personalized dietary prescriptions for participants. Besides, peer support is implemented as a self management strategy in community health service centers or community self management groups to enhance the behavioral change support for these participants.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Behavior intervention including health education on diet, exercises and self management support through peer support, and also receive regular care and follow up in community health centers Receives: Behavioral: Healthy diet, regular exercises and peer support |
| Control arm | No intervention | Receiving regular care and follow up in Community health centers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of BMI from baseline at 12 months
body mass index, using the examination results of height (cm) and weight (kg)
Measured: Baseline, 12 months
Secondary outcomes (8)
Change of HbA1c from baseline at 12 months
hemoglobin A1c (%)
Measured: Baseline, 12 months
Change of Waist circumference from baseline at 12 months
Waist circumference (cm)
Measured: Baseline, 12 months
Change of Fasting Plasma Glucose from baseline at 12 months
fasting plasma glucose (mmol/L)
Measured: Baseline, 12 months
Change of Blood Pressure from baseline at 12 months
Blood pressure including systolic blood pressure and diastolic blood pressure (mmHg)
Measured: Baseline, 12 months
Change of Total Cholesterol from baseline at 12 months
total cholesterol (mmol/L)
Measured: Baseline, 12 months
Change of Triglyceride from baseline at 12 months
Triglyceride (mmol/L)
Measured: Baseline, 12 months
Change of High density lipoprotein cholesterol from baseline at 12 months
High density lipoprotein-Cholesterol (mmol/L)
Measured: Baseline, 12 months
Change of Low density lipoprotein cholesterol from baseline at 12 months
Low density lipoprotein-Cholesterol (mmol/L)
Measured: Baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Dec 2019
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Municipal Center for Disease Control and Prevention
- Responsible party
- Principal investigator, Weiping Jia, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256460
- Sponsor's protocol ID
- Shanghai6
- Status last verified
- May 2024
- First submitted
- 16 Oct 2019
- Last updated
- 14 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shanghai Community Prediabetes Standardized Management Project
- ClinicalTrials.gov ID
- NCT04256460
- Acronym / sponsor ID
- Shanghai6
- Conditions
- PreDiabetes
- Keywords
- prediabetes, life style intervention, peer support, self management support, primary healthcare, community
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (actual)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Collaborators
- Shanghai Municipal Center for Disease Control and Prevention
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 5 Feb 2020 (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.
Participants with prediabetes is the key targets for diabetes prevention. So, in order to further strengthen and standardize the management of participants with prediabetes in the communities, the investigators start this project of standardized management of participants with prediabetes in communities of Shanghai. Explore the standardized management model for prediabetes participants within primary healthcare settings in Shanghai, to reduce the risk factors of diabetes, improve the blood glucose control, and the quality of life of participants with prediabetes.
Detailed description
Participants with prediabetes is the key targets for diabetes prevention. So, in order to further strengthen and standardize the management of participants with prediabetes in the communities, the investigators start this project of standardized management of participants with prediabetes in communities of Shanghai. Explore the standardized management model for prediabetes participants within primary healthcare settings in Shanghai, to reduce the risk factors of diabetes, improve the blood glucose control, and the quality of life of participants with prediabetes.
Through the collaboration the Shanghai Municipal Center for Disease Control \& Prevention network, this investigators will implement prediabetes screening and lifestyle intervention in around 50 community health service centers in Shanghai. Life-style interventions including exercise and diet, and diabetes prevention knowledge will be integrated into "train-the-trainers" workshops. Trainings will be provided to community health service staff and peer supporters or social workers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Healthy diet, regular exercises and peer supportBehavior intervention including health education on diet, exercises and self management support through peer support, and also receive regular care and follow up in community health centers |
| Control arm | No intervention | –Receiving regular care and follow up in Community health centers |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chinese residents
- Adult age ≥ 18 years old, 35-75 years old preferred
- Participants receiving prediabetes management of the basic public health services package in community health centers
- BMI≥24 kg/m2 or central obesity (Waist circumference≥90 cm in males，Waist circumference≥85 cm in females) or Hypertension (SBP≥140 mmHg and/or DBP≥90 mmHg) preferred
- Signed informed consents and willing to participate
Key exclusion criteria (5 listed)
- With serious chronic diseases, tumors, acute and chronic infectious diseases, limb movement disorders, and any mental illnesses
- Women during pregnancy or breastfeeding
- With excessive drinking or illicit drug use
- Unwilling to participate in the project
- Histories of severe cardiovascular events (myocardial infarction, stroke, acute coronary syndrome, or transient ischemic attack (TIA))
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 |
|---|---|---|
| Healthy diet, regular exercises and peer supportAfter assessing the exercise and nutritional status of the participants, health staff in community health centers implemented personalized healthy diet and regular exercises intervention, including coaching on healthy exercises and developing personalized dietary prescriptions for participants. Besides, peer support is implemented as a self management strategy in community health service centers or community self management groups to enhance the behavioral change support for these participants. | Behavioural | Intervention arm |
Primary outcome
Change of BMI from baseline at 12 months
Time frame: Baseline, 12 months
body mass index, using the examination results of height (cm) and weight (kg)
8 secondary outcomes
Change of HbA1c from baseline at 12 months
Time frame: Baseline, 12 months
Change of Waist circumference from baseline at 12 months
Time frame: Baseline, 12 months
Change of Fasting Plasma Glucose from baseline at 12 months
Time frame: Baseline, 12 months
Change of Blood Pressure from baseline at 12 months
Time frame: Baseline, 12 months
Change of Total Cholesterol from baseline at 12 months
Time frame: Baseline, 12 months
Change of Triglyceride from baseline at 12 months
Time frame: Baseline, 12 months
Change of High density lipoprotein cholesterol from baseline at 12 months
Time frame: Baseline, 12 months
Change of Low density lipoprotein cholesterol from baseline at 12 months
Time frame: Baseline, 12 months
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 14 May 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
53 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy diet, regular exercises and peer support in people with PreDiabetes, run by Shanghai 6th People's Hospital at 53 sites 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 5 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 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites 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?
Change of BMI from baseline at 12 months (time frame: Baseline, 12 months). 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 14 May 2024.