Lifestyle Modification Intervention in Pre-diabetic Subjects

Evaluation on Prevention for Metabolic Syndrome and Diabetes Mellitus Through Lifestyle Modification Intervention in Prediabetic Subjects

Sponsors

Lead Sponsor: Taipei Medical University

Collaborator: Ministry of Health and Welfare, Taiwan

Source 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.

Overall Status Unknown status
Start Date 2012-03-07
Completion Date 2018-12-31
Primary Completion Date 2013-03-18
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
blood sugar 3 month, 6 month and 12-month follow up
Secondary Outcome
Measure Time Frame
body weight 3 month, 6 month and 12-month follow up
BMI 3 month, 6 month and 12-month follow up
Metabolic syndrome 3 month, 6 month and 12-month follow up
Enrollment 300
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: lifestyle modification intervention

Description: healthy lifestyle education and individualized counseling by well-trained case manager. The main goals of the lifestyle intervention included regular moderate intensity physical activity 150 min per week or more, and dietary strategies which reduce the risk of developing diabetes. The dietary suggestion was modified by Dietary Approaches to Stop Hypertension (DASH) Diet. Participants with BMI>= 24 kg/m2 were encouraged to gradually lose weight at a rate of 0.5-1.0 kg per week until they achieved a BMI of 24 kg/m2.

Arm Group Label: lifestyle intervention group

Eligibility

Criteria:

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.

Gender:

All

Minimum Age:

40 Years

Maximum Age:

90 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Hung-Yi Chiou, PhD Study Chair School of Public Health, Taipei Medical University
Overall Contact Contact information is only displayed when the study is recruiting subjects.
Location
Facility: Status:
YUANH | Kaohsiung, Lingya Dist, 802, Taiwan Active, not recruiting
SKH | Taipei, Shilin Dist., 111, Taiwan Recruiting Yu-Ling Li, PhD student +886227361661 6512 [email protected]
TMUH | Taipei, Sinyi District,, 110, Taiwan Recruiting Yu-Ling Li, PhD student +886227361661 6512 [email protected]
MMH | Taipei, Zhongshan Dist., 104, Taiwan Recruiting Yu-Ling Li, PhD student +886227361661 6512 [email protected]
Location Countries

Taiwan

Verification Date

2017-06-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: lifestyle intervention group

Type: Experimental

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.

Label: control group

Type: No Intervention

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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Single (Participant)

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