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

Primary Purpose

Overweight, Metabolic Abnormality

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Mobile physical activity promotion tool
Standard care
Sponsored by
National Cheng-Kung University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring Physical activity, mobile activity sensor and feedback system, self-management of health

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Cheng Kung University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MT and life counseling

Standard care

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Increase physical fitness
Measurement by examination of physical fitness.

Full Information

First Posted
September 23, 2014
Last Updated
October 7, 2015
Sponsor
National Cheng-Kung University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02249611
Brief Title
Application of MT in Subjects With Overweight/Metabolic Abnormality---RCT
Official Title
Application of Mobile Physical Activity Promotion Tool in Subjects With Overweight/Metabolic Abnormality---randomised Control Trial of Efficacy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cheng-Kung University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Metabolic Abnormality
Keywords
Physical activity, mobile activity sensor and feedback system, self-management of health

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MT and life counseling
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard care
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Mobile physical activity promotion tool
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Standard care
Other Intervention Name(s)
Counseling on lifestyles
Intervention Description
Counseling on lifestyles with health education material
Primary Outcome Measure Information:
Title
Increase physical activity
Description
Measurement by mobile activity sensor system and the questionnaire of International Physical Activity Questionnaires (IPAQ) short form, and evaluate by counts/minute
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Increase physical fitness
Description
Measurement by examination of physical fitness.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
executive performance of participants
Description
physiological indicators and other metabolic and biochemical indicators, the questionnaire of psychological health, and WHO health related quality of life to evaluate executive performance of participants
Time Frame
6 months
Title
diet record compliance
Description
Measurement by records of web survey
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Ching Yang, MD
Organizational Affiliation
Department of Family Medicine, College of Medicine, National Cheng Kung University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cheng Kung University
City
Tainan
ZIP/Postal Code
701
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
28729003
Citation
Yang YP, Wang CJ, Wang JJ, Lin CW, Yang YC, Wang JS, Yang YK, Yang YC. The Effects of an Activity Promotion System on active living in overweight subjects with metabolic abnormalities. Obes Res Clin Pract. 2017 Nov-Dec;11(6):718-727. doi: 10.1016/j.orcp.2017.06.002. Epub 2017 Jul 17.
Results Reference
derived

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

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