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

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

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.

Study Overview

• Status: Completed
• Conditions: Overweight; Metabolic Abnormality
• Intervention / Treatment: Device: Mobile physical activity promotion tool; Other: Standard care

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.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan, 701
    • National Cheng Kung University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Mobile physical activity promotion tool; 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
Active Comparator: 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).	Other: Standard care; Counseling on lifestyles with health education material; Other Names: Counseling on lifestyles

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
executive performance of participants	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	6 months
diet record compliance	Measurement by records of web survey	3 months

Collaborators and Investigators

• Sponsor: National Cheng-Kung University Hospital
• Investigators: Principal Investigator: Yi Ching Yang, MD, Department of Family Medicine, College of Medicine, National Cheng Kung University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: September 23, 2014
• First Submitted That Met QC Criteria: September 23, 2014
• First Posted (Estimate): September 25, 2014

Study Record Updates

• Last Update Posted (Estimate): October 9, 2015
• Last Update Submitted That Met QC Criteria: October 7, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Physical activity; mobile activity sensor and feedback system; self-management of health
• Additional Relevant MeSH Terms: Body Weight; Congenital Abnormalities; Overweight
• Other Study ID Numbers: NSC 102-2314-B-006 -004 -MY2