Lifestyle Modification Intervention in Pre-diabetic Subjects

Taipei Medical University

Status: Unknown

Conditions: PreDiabetes

Treatments: Behavioral: lifestyle modification intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03211182

201110024

Details and patient eligibility

About

The lifestyle intervention program focusing on healthy dietary habit and exercise effectively prevents progression to diabetes. Thus, the purpose of this study was to assess the effectiveness of lifestyle intervention program on pre-diabetics subjects in Taiwan.

Full description

The study is a 2-parallel groups' randomized controlled trial. Participants with elevated fasting plasma glucose concentrations (FPG 100-125 mg/dl) or glycated hemoglobin (HbA1C 5.7-6.3%) are enrolled. All study subjects are randomized to receive a lifestyle intervention (intervention group) or regular prevention education (control group). The parameters are obtained from physical examination and biochemical assessments by well-trained case manager at baseline and each follow visit (3th months, 6th months and 12th months). All participants complete a structured questionnaire, including basic information, disease history, physical activity, food-frequency, stage of change, and social support situation.

Enrollment: 300 estimated patients

Sex: All

Ages: 40 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 40 years old or over
• elevated fasting plasma glucose concentrations (FPG: 100-125 mg/dl) or glycated hemoglobin(HbA1C: 5.7-6.3%)

Exclusion criteria

• having received a diagnosis of diabetes or receiving treatment for diabetes in 3 years
• having a history of cardiovascular disease, stroke, liver disease, kidney disease, cardiopulmonary disease, malignancy or cancer and musculoskeletal impairment
• receiving corticosteroids, androgens, estrogen containing compounds
• who had dietary problem
• pregnant women
• who joined other health intervention study in one year.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

lifestyle intervention group

Experimental group

Description:

The intervention group was given healthy lifestyle education and individualized counseling by well-trained case manager at baseline, and follow-up phone counseling thereafter.

Treatment:

Behavioral: lifestyle modification intervention

control group

No Intervention group

Description:

The control group was given general verbal and written health behavior information to prevent diabetes at baseline without specific individualized advice.