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NCT Number: NCT04256460

Shanghai Community Prediabetes Standardized Management Project

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.

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Key information

Conditions

PreDiabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anting community health service center, Shanghai, Shanghai Municipality, China

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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.

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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))

Treatment and study plan

Healthy diet, regular exercises and peer support

Behavioral

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Change of HbA1c from baseline at 12 months

    Time frame: Baseline, 12 months

    hemoglobin A1c (%)

  2. Change of Waist circumference from baseline at 12 months

    Time frame: Baseline, 12 months

    Waist circumference (cm)

  3. Change of Fasting Plasma Glucose from baseline at 12 months

    Time frame: Baseline, 12 months

    fasting plasma glucose (mmol/L)

  4. Change of Blood Pressure from baseline at 12 months

    Time frame: Baseline, 12 months

    Blood pressure including systolic blood pressure and diastolic blood pressure (mmHg)

  5. Change of Total Cholesterol from baseline at 12 months

    Time frame: Baseline, 12 months

    total cholesterol (mmol/L)

  6. Change of Triglyceride from baseline at 12 months

    Time frame: Baseline, 12 months

    Triglyceride (mmol/L)

  7. Change of High density lipoprotein cholesterol from baseline at 12 months

    Time frame: Baseline, 12 months

    High density lipoprotein-Cholesterol (mmol/L)

  8. Change of Low density lipoprotein cholesterol from baseline at 12 months

    Time frame: Baseline, 12 months

    Low density lipoprotein-Cholesterol (mmol/L)

Other outcomes

  1. Change of Liver Functioning from baseline at 12 months

    Time frame: Baseline, 12 months

    alanine transaminase (U/L), Aspartate transaminase (U/L), Alkaline phosphatase (U/L), glutamyltransferase (U/L)

  2. Change of Urine Albumin/Creatinine Ratio from baseline at 12 months

    Time frame: Baseline, 12 months

    Albumin (mg/L), Creatinine (mmol/L)

  3. Change of Bilirubin from baseline at 12 months

    Time frame: Baseline, 12 months

    Total bilirubin (μmol/L), Direct bilirubin (μmol/L)

    Total bilirubin (μmol/L), Direct bilirubin (μmol/L)

  4. Change of Blood Urea from baseline at 12 months

    Time frame: Baseline, 12 months

    Blood urea (mmol/L)

  5. Change of Serum Creatinine from baseline at 12 months

    Time frame: Baseline, 12 months

    Serum creatinine (μmol/L)

  6. Change of Uric Acid from baseline at 12 months

    Time frame: Baseline, 12 months

    Uric acid (μmol/L)

  7. Change of oral glucose tolerance test-2 hour from baseline at 12 months

    Time frame: Baseline, 12 months

    oral glucose tolerance test-2 hour (mmol/L)

  8. Change of Diabetes Self Care Behaviors from baseline at 12 months

    Time frame: Baseline, 12 months

    9 items from Summary of Diabetes Self Care Activities and Behavioral Risk Factor Surveillance System. Items 1-7 measure diabetes self care activities during the previous 7 days. Items 1, 2, 4-7 are assessed on a scale of 0 to 7 days. Item 3 is assessed on scale of 1-4, where 1 represents very low levels of daily activity and 4 represents very high levels of daily activity. Items 8 and 9 are yes/no questions that measure cigarette intake over the past 7 and 30 days.

  9. Change of General Quality of Life from baseline at 12 months

    Time frame: Baseline, 12 months

    6-item Euro quality-of-life-5D, a standardized instrument for measuring generic health status. The respondents are asked to choose one of the statements which best describes their health status on the surveyed day. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions). Item 6 is the visual analogue scale, in which respondents are asked to mark their health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100, where 0 corresponds to "the worst health you can imagine", and 100 corresponds to "the best health you can imagine"

  10. Change of Diabetes Quality of Life from baseline at 12 months

    Time frame: Baseline, 12 months

    4-item Diabetes Distress Scale, an abbreviated version of the 17-item Diabetes Distress Scale. The respondents are asked to respond to which degree each of the items has bothered them in the past month on a 6-point scale (1-6), where 1 is not a brother and 6 is very bothersome. Scores are summed and divided by 4 to calculate the mean. Mean scores of 3 or higher (moderate distress) are considered worthy of clinical attention.

  11. Change of Depression from baseline at 12 months

    Time frame: Baseline, 12 months

    8-item Patient Health Questionnaire (PHQ), the PHQ-9 minus the last question on suicidal thoughts. The PHQ is a standard instrument used in primary care settings to screen for the presence and severity of depression. The respondents are asked how often they have been bothered by each of the 8 items in the past 2 weeks on a 4 point scale (0-3), where 0 is "not all" and 3 is "nearly every day". The scores for each item are summed to produce a total score between 0 and 24 points. A total score of 0 to 4 represents no significant depressive symptoms. A total score of 5 to 9 represents mild depressive symptoms; 10 to 14, moderate; 15 to 19, moderately severe; and 20 to 24, severe.

  12. Change of Insulin Attitudes from baseline at 12 months

    Time frame: Baseline, 12 months

    6 questions

  13. Change of Neighborhood Interactions from baseline at 12 months

    Time frame: Baseline, 12 months

    6 questions

  14. Change of Peer Support Engagement and Health Care Utilization from baseline at 12 months

    Time frame: Baseline, 12 months

    5 questions

  15. Change of General information and risk factors questionnaire from baseline at 12 months

    Time frame: Baseline, 12 months

    Demographic questions, medical histories, risk factors including family history, smoking, alcohol drinking, diet, and exercises, medication information and adherence.

  16. Change of C-reaction protein from baseline at 12 months

    Time frame: Baseline, 12 months

    C-reaction protein

Sponsors and collaborators

Lead sponsor

Shanghai 6th People's Hospital

Other

Collaborators

  • Shanghai Municipal Center for Disease Control and Prevention

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Feb 5, 2020
Registry last updated
May 14, 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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