NCT04567121

Brief Summary

This study aims to control risk factors of non communicable diseases by life style and care intervention based on internet technology, looking forward to improve cardiovascular and cerebrovascular complications, diabetes and all-cause death.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60,000

participants targeted

Target at P75+ for not_applicable

Timeline
542mo left

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Jan 2018Dec 2070

Study Start

First participant enrolled

January 1, 2018

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 28, 2020

Completed
49.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2070

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2070

Last Updated

February 11, 2025

Status Verified

May 1, 2024

Enrollment Period

52 years

First QC Date

September 7, 2020

Last Update Submit

February 9, 2025

Conditions

Lifestyle InterventionNon Communicable Diseases

Keywords

Internet Technologylifestyle interventionNon Communicable Diseases

Outcome Measures

Primary Outcomes (3)

  • incidence rate of new noncommunicable diseases

    incidence rate of new noncommunicable diseases, for example, ASCVD, diabetes mellitus, hypertension

    2 year

  • incidence rate of major adverse cardiovascular events

    incidence rate of major adverse cardiovascular events, including nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death

    2 years

  • incidence rate of all-cause mortality

    incidence rate of all-cause mortality in the population

    2 years

Secondary Outcomes (2)

  • score of quality of life (SF-36 scale)

    2 years

  • Reduce the economic burden on health

    2 years

Study Arms (2)

Intensive intervention group

OTHER

intensive life-style and care intervention

Behavioral: Intensive intervention group

Standard intervention group

OTHER

standard life-style and care intervention

Behavioral: standard intervention group

Interventions

Intensive intervention groupBEHAVIORAL

Establish a team of chronic disease prevention managers (5 people), with each educator responsible for the intervention of 200 people. For sub-health population and chronic disease patients, there would be conducted health education interview twice, 4 calls, online communication 50 times once a year, controlling risk factors and making treatment plan.

Intensive intervention group
standard intervention groupBEHAVIORAL

Conduct general health education without active management

Standard intervention group

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women older than 25 years of age with two or more risk factors as follows, BMI≥24 or BMI≤18.5 kg/m2, smoking, active exercise less than 30 minutes every day, blood pressure higher than 130/85 mmHg, dyslipidemia, fasting glucose higher than 6.1mmol/l, fatty liver.
  • Patients with hypertension, diabetes and ASCVD

You may not qualify if:

  • Patients had not signed the consent form
  • Patients with severe heart failure, hepatic failure, renal failure and malignant tumor.
  • Patients planing pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, Beijing, BJ 10, China

RECRUITING

MeSH Terms

Conditions

Noncommunicable Diseases

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • jianzhong xiao, PHD

    Beijing Tsinghua Changgeng Hospital

    STUDY DIRECTOR

Central Study Contacts

jianzhong xiao, PHD

CONTACT

+8613683685711xiaojzh858@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2020

First Posted

September 28, 2020

Study Start

January 1, 2018

Primary Completion (Estimated)

January 1, 2070

Study Completion (Estimated)

December 1, 2070

Last Updated

February 11, 2025

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)