Lifestyle Modification Intervention in Pre-diabetic Subjects

Not Applicable

• Conditions: PreDiabetes
• Interventions: Behavioral: lifestyle modification intervention

• Registration Number: NCT03211182
• Lead Sponsor: Taipei Medical University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2012-03-07
• Primary Completion: 2013-03-18
• Status Verified: 2017-06
• Study First Submitted: 2017-06-29
• Study First Submitted QC: 2017-07-05
• Last Update Submitted: 2017-07-05
• Study First Posted: 2017-07-07
• Last Update Posted: 2017-07-07
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
blood sugar	3 month, 6 month and 12-month follow up	changes in fasting glucose and glycated hemoglobin

Secondary Outcome Measures

Name	Time	Method
body weight	3 month, 6 month and 12-month follow up	weight in kilograms
BMI	3 month, 6 month and 12-month follow up	weight and height will be combined to report BMI in kg/m\^2
Metabolic syndrome	3 month, 6 month and 12-month follow up	defined as 3 or more of 5 components (ie, abdominal obesity, elevated blood pressure, elevated triglycerides, low high-density lipoprotein cholesterol, and dysglycemia)

Trial Locations

Locations (4)

YUANH; 🇨🇳 Kaohsiung, Lingya Dist, Taiwan

SKH; 🇨🇳 Taipei, Shilin Dist., Taiwan

TMUH; 🇨🇳 Taipei, Sinyi District,, Taiwan

MMH; 🇨🇳 Taipei, Zhongshan Dist., Taiwan