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A Behavioral Intervention to Prevent Impaired Glucose Tolerance Diabetes Mellitus (DIGITAL-I)

NCT03987438 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1336

Last updated 2019-09-04

No results posted yet for this study

Summary

The national epidemiological survey showed that the prevalence rate of pre-diabetes was up to 35.7% in China. Previous study indicated that lifestyle intervention in people with impaired glucose tolerance could delay the onset of type 2 diabetes. However, patients with pre-diabetes do not pay enough attention to their glucose metabolism, and most of them rarely monitor their blood glucose. With the increasing use of smartphones, mobile applications (APPs) can be applied in the education and management of chronic diseases, including diabetes. Thus, the investigators will conduct a multi-centered, two-armed, open-labeled, randomized controlled trial to evaluate whether the behavioral intervention by a mobile APP can prevent the occurrence of diabetes in people with impaired glucose tolerance.

The investigators hypothesize that behavioral intervention in pre-diabetes with using a mobile APP that incorporates nutrition, exercise and psychological support from trained professional doctors will:

1. Reduce the risk of the onset of diabetes in people with impaired glucose tolerance.
2. Increase the reversal rate of becoming normal glucose tolerance and reduce the levels of glycosylated hemoglobin in pre-diabetes.

Conditions

Interventions

BEHAVIORAL

Lifestyle intervention with APP

The lifestyle intervention will be launched by an APP installed in participants' private mobile phones, including health knowledge education, mental health counseling, smart diet advice, intelligent exercise guidance, and target weight management. Nutrition recommendation is conducted according to the Chinese Dietary Guide, Chinese and International Guidelines of Gestation Diabetes Management. Exercise guidance is given based on the Guidelines for National Fitness of China, Chinese and International Guidelines of Gestation Diabetes Management. Psychological support is given by sending education articles on mental health. Participants are encouraged to update data about their diet, exercise and body weight through the APP. The face to face education class will be conducted by an obstetrician, an endocrinologist and a nutritionist together to modify the behavioral supports individually based on the feedback of their characteristics and performance recorded in the APP.

Sponsors & Collaborators

  • Peking University Third Hospital

    lead OTHER

Principal Investigators

  • Tianpei Hong, MD,PhD · Peking University Third Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-03
Primary Completion
2020-11-30
Completion
2020-12-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03987438 on ClinicalTrials.gov