Application of MT in Subjects With Overweight/Metabolic Abnormality---RCT

Study Overview
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Brief Summary
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The subjects will be recruited from July 1, 2014 until the participants enough. Interviewing for research purpose explication and informed consent will be collected before the study is executed. In the first 3 months, subjects of group A will use the mobile physical activity promotion tool (MT), receive professional personal counseling, and individualized reminding message (intervention) once a week. In the last 3 months, they will receive standard care (control) which is in support of behavioral and educational recommendations in diet control, increased physical activity, less smoking and drinking, deal with pressure, and regular health examination (based on the booklet of metabolic syndrome prevention which is edited by Health Promotion Administration, Ministry of Health and Welfare, Taiwan). Subjects of group B will begin with an initial 3 months control period of standard care only, and the intervention program will be conducted for last 3 months.

Detailed Description
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RCT with a crossover design will present in this study and take place during a 6-month period. Participants will be randomly allocated to two groups applying a randomized block technique and matching with different age and sex. The subjects will be recruited from July 1, 2014 until the participants enough. Interviewing for research purpose explication and informed consent will be collected before the study is executed. Physical activity amount (including mild, moderate and vigorous physical activity), cardio-respiratory fitness (including three minutes of stair-climbing and a minute sit-up), physiological indicators (blood pressure, weight, waist circumference, and body composition), metabolic and biochemical indicators (including glucose level, lipid profile etc.), and the questionnaire of psychological health and quality of life will be recorded at the first visit. And then subjects will be followed after 12 weeks and 24 weeks. Additionally, diet record compliance will be recorded for 12 weeks. In the first 3 months, subjects of group A will use the mobile physical activity promotion tool (MT), receive professional personal counseling, and individualized reminding message (intervention) once a week. In the last 3 months, they will receive standard care (control) which is in support of behavioral and educational recommendations in diet control, increased physical activity, less smoking and drinking, deal with pressure, and regular health examination (based on the booklet of metabolic syndrome prevention which is edited by Health Promotion Administration, Ministry of Health and Welfare, Taiwan). Subjects of group B will begin with an initial 3 months control period of standard care only, and the intervention program will be conducted for last 3 months.

Official Title
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Application of Mobile Physical Activity Promotion Tool in Subjects With Overweight/Metabolic Abnormality---randomised Control Trial of Efficacy

Conditions
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Overweight, Metabolic Abnormality

Intervention / Treatment
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* Device: Mobile physical activity promotion tool
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Body Mass Index (BMI) ≥ 24kgw/m2, Waist circumference, male≥ 90cm, female≥ 80cm, Systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85mmHg, Fast plasma glucose ≥ 100mg/dL, High-density lipoprotein cholesterol (HDL-C): male<40 mg/dL, female<50 mg/dL, Triglyceride ≥ 150 mg/dL. Exclusion criteria: can't use computer, internet, and smartphone, is pregnant, within 6 months after delivery and on breastfeeding, is exercise-intolerance. use the relevant drugs for weight reduction, cardiovascular diseases, hypertension, diabetes and dyslipidemia.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MT and life counseling<br>To improve physical activity, body composition, physiological parameters and quality of life by using MT (mobile physical activity promotion tool) and lifestyle counseling in diet control, increased physical activity, less smoking and drinking, deal with pressure, and regular health examination will be conducted for 3 months in intervention periods. | Device: Mobile physical activity promotion tool<br>* Mobile activity sensor Smartphone with APP Interactional webpage of internet Evidence based health information Individualized reminding messages according to the data from activity recording system Personal counseling from professional personnel<br>|
| Active Comparator: Standard care<br>Lifestyle counseling in diet control, increased physical activity, less smoking and drinking, deal with pressure, and regular health examination based on the booklet of metabolic syndrome prevention which is edited by Health Promotion Administration, Ministry of Health and Welfare in Taiwan only once in this period (3 months). | Other: Standard care<br>* Counseling on lifestyles with health education material<br>* Other names: Counseling on lifestyles;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase physical activity | Measurement by mobile activity sensor system and the questionnaire of International Physical Activity Questionnaires (IPAQ) short form, and evaluate by counts/minute | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase physical fitness | Measurement by examination of physical fitness. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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self-management of health, Physical activity, mobile activity sensor and feedback system