PreDiabetesNCT03211182
Lifestyle Modification Intervention in Pre-diabetic Subjects
A study testing lifestyle modification intervention in people with PreDiabetes, run by Taipei Medical University at 4 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes
- What is being tested?
- lifestyle modification intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 4 sitesTaiwan
- Study dates
- 7 Mar 2012to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 40 years old or over
- elevated fasting plasma glucose concentrations (FPG: 100-125 mg/dl) or glycated hemoglobin(HbA1C: 5.7-6.3%)
Who cannot join
- 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 locations and contacts
4 sites in 1 country.
Taiwan4 sites, 3 recruiting
- Active, not recruiting
YUANH
Kaohsiung City, Lingya Dist, 802
- Recruiting
SKH
Taipei, Shilin Dist., 111
Yu-Ling Li, PhD student, +886227361661 ext. 6512, evelyn.tmu@gmail.com
- Recruiting
TMUH
Taipei, Sinyi District,, 110
Yu-Ling Li, PhD student, +886227361661 ext. 6512, evelyn.tmu@gmail.com
- Recruiting
MMH
Taipei, Zhongshan Dist., 104
Yu-Ling Li, PhD student, +886227361661 ext. 6512, evelyn.tmu@gmail.com
About this study
Official title: Evaluation on Prevention for Metabolic Syndrome and Diabetes Mellitus Through Lifestyle Modification Intervention in Prediabetic Subjects
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.
Read the 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.
- Conditions
- PreDiabetes
- Being tested
- lifestyle modification intervention
- Keywords
- lifestyle intervention, prediabetes
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle modification interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| lifestyle intervention group | Experimental | The intervention group was given healthy lifestyle education and individualized counseling by well-trained case manager at baseline, and follow-up phone counseling thereafter. Receives: Behavioral: lifestyle modification intervention |
| control group | No intervention | The control group was given general verbal and written health behavior information to prevent diabetes at baseline without specific individualized advice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood sugar
changes in fasting glucose and glycated hemoglobin
Measured: 3 month, 6 month and 12-month follow up
Secondary outcomes (3)
body weight
weight in kilograms
Measured: 3 month, 6 month and 12-month follow up
BMI
weight and height will be combined to report BMI in kg/m^2
Measured: 3 month, 6 month and 12-month follow up
Metabolic syndrome
defined as 3 or more of 5 components (ie, abdominal obesity, elevated blood pressure, elevated triglycerides, low high-density lipoprotein cholesterol, and dysglycemia)
Measured: 3 month, 6 month and 12-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start7 Mar 2012
- Primary completion18 Mar 2013
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan
- Responsible party
- Sponsor
- Investigators
- Hung-Yi Chiou, PhD, Study chair, School of Public Health, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211182
- Sponsor's protocol ID
- 201110024
- Status last verified
- Jun 2017
- First submitted
- 29 Jun 2017
- Last updated
- 7 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation on Prevention for Metabolic Syndrome and Diabetes Mellitus Through Lifestyle Modification Intervention in Prediabetic Subjects
- ClinicalTrials.gov ID
- NCT03211182
- Acronym / sponsor ID
- 201110024
- Conditions
- PreDiabetes
- Keywords
- lifestyle intervention, prediabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan
- Study start
- 7 Mar 2012 (actual)
- Primary completion
- 18 Mar 2013 (actual)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 7 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lifestyle intervention group | Experimental | Behavioral: lifestyle modification interventionThe 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 intervention | –The control group was given general verbal and written health behavior information to prevent diabetes at baseline without specific individualized advice. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 40 years old or over
- elevated fasting plasma glucose concentrations (FPG: 100-125 mg/dl) or glycated hemoglobin(HbA1C: 5.7-6.3%)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lifestyle modification interventionhealthy 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. | Behavioural | lifestyle intervention group |
Primary outcome
blood sugar
Time frame: 3 month, 6 month and 12-month follow up
changes in fasting glucose and glycated hemoglobin
3 secondary outcomes
body weight
Time frame: 3 month, 6 month and 12-month follow up
BMI
Time frame: 3 month, 6 month and 12-month follow up
Metabolic syndrome
Time frame: 3 month, 6 month and 12-month follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hung-Yi Chiou, PhD study chair
School of Public Health, Taipei Medical University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lifestyle modification intervention in people with PreDiabetes, run by Taipei Medical University at 4 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hung-Yi Chiou, PhD (+88627361661 ext. 6512, hychiou@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood sugar (time frame: 3 month, 6 month and 12-month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2017.