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

NCT ID: NCT02249611

Last Updated: 2015-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-10-31

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.

Conditions

Overweight; Metabolic Abnormality

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

MT and life counseling

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.

Group Type: EXPERIMENTAL

Mobile physical activity promotion tool

Intervention Type: DEVICE

1. Mobile activity sensor

2. Smartphone with APP

3. Interactional webpage of internet

4. Evidence based health information

5. Individualized reminding messages according to the data from activity recording system

6. Personal counseling from professional personnel

Standard care

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).

Group Type: ACTIVE_COMPARATOR

Standard care

Intervention Type: OTHER

Counseling on lifestyles with health education material

Interventions

Mobile physical activity promotion tool

1. Mobile activity sensor

2. Smartphone with APP

3. Interactional webpage of internet

4. Evidence based health information

5. Individualized reminding messages according to the data from activity recording system

6. Personal counseling from professional personnel

Intervention Type: DEVICE

Standard care

Counseling on lifestyles with health education material

Intervention Type: OTHER

Other Intervention Names

Counseling on lifestyles

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cheng-Kung University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yi-Ching Yang

MD, professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yi Ching Yang, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Family Medicine, College of Medicine, National Cheng Kung University

Locations

National Cheng Kung University

Tainan City, , Taiwan

Countries

Taiwan

References

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.

Reference Type: DERIVED

PMID: 28729003 (View on PubMed)

Other Identifiers

NSC 102-2314-B-006 -004 -MY2

Identifier Type: -

Identifier Source: org_study_id