Lifestyle Modification Intervention in Pre-diabetic Subjects

NCT ID: NCT03211182

Last Updated: 2017-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-07

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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PreDiabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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lifestyle intervention group

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

Group Type EXPERIMENTAL

lifestyle modification intervention

Intervention Type BEHAVIORAL

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.

control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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lifestyle modification intervention

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ministry of Health and Welfare, Taiwan

OTHER_GOV

Sponsor Role collaborator

Taipei Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hung-Yi Chiou, PhD

Role: STUDY_CHAIR

School of Public Health, Taipei Medical University

Locations

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YUANH

Kaohsiung City, Lingya Dist, Taiwan

Site Status ACTIVE_NOT_RECRUITING

SKH

Taipei, Shilin Dist., Taiwan

Site Status RECRUITING

TMUH

Taipei, Sinyi District,, Taiwan

Site Status RECRUITING

MMH

Taipei, Zhongshan Dist., Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Hung-Yi Chiou, PhD

Role: CONTACT

+88627361661 ext. 6512

Yu-Ling Li, PhD student

Role: CONTACT

+886227361661 ext. 6512

Facility Contacts

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Yu-Ling Li, PhD student

Role: primary

+886227361661 ext. 6512

Yu-Ling Li, PhD student

Role: primary

+886227361661 ext. 6512

Yu-Ling Li, PhD student

Role: primary

+886227361661 ext. 6512

Other Identifiers

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201110024

Identifier Type: -

Identifier Source: org_study_id

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