Clinical trial NCT02249611: 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
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Metabolic Abnormality
Keywords: Physical activity
mobile activity sensor and feedback system
self-management of health
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2014-09-25
Enrollment: 53
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Increase physical activity
timeFrame: 6 months
Secondary outcomes:
measure: Increase physical fitness
timeFrame: 6 months
Other outcomes:
measure: executive performance of participants
timeFrame: 6 months
measure: diet record compliance
timeFrame: 3 months
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University
Study officials:
affiliation: Department of Family Medicine, College of Medicine, National Cheng Kung University
name: Yi Ching Yang, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.