Lifestyle Modification Intervention in Pre-diabetic Subjects
Evaluation on Prevention for Metabolic Syndrome and Diabetes Mellitus Through Lifestyle Modification Intervention in Prediabetic Subjects
1 other identifier
interventional
300
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2012
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 7, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 18, 2013
CompletedFirst Submitted
Initial submission to the registry
June 29, 2017
CompletedFirst Posted
Study publicly available on registry
July 7, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedJuly 7, 2017
June 1, 2017
1 year
June 29, 2017
July 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
blood sugar
changes in fasting glucose and glycated hemoglobin
3 month, 6 month and 12-month follow up
Secondary Outcomes (3)
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
Study Arms (2)
lifestyle intervention group
EXPERIMENTALThe intervention group was given healthy lifestyle education and individualized counseling by well-trained case manager at baseline, and follow-up phone counseling thereafter.
control group
NO INTERVENTIONThe control group was given general verbal and written health behavior information to prevent diabetes at baseline without specific individualized advice.
Interventions
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.
Eligibility Criteria
You may qualify if:
- years old or over
- elevated fasting plasma glucose concentrations (FPG: 100-125 mg/dl) or glycated hemoglobin(HbA1C: 5.7-6.3%)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Taipei Medical Universitylead
- Ministry of Health and Welfare, Taiwancollaborator
Study Sites (4)
YUANH
Kaohsiung City, Lingya Dist, 802, Taiwan
SKH
Taipei, Shilin Dist., 111, Taiwan
TMUH
Taipei, Sinyi District,, 110, Taiwan
MMH
Taipei, Zhongshan Dist., 104, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hung-Yi Chiou, PhD
School of Public Health, Taipei Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2017
First Posted
July 7, 2017
Study Start
March 7, 2012
Primary Completion
March 18, 2013
Study Completion
December 31, 2018
Last Updated
July 7, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share