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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02249611
Enrollment
53
Registered
2014-09-25
Start date
2014-07-31
Completion date
2015-10-31
Last updated
2015-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Abnormality, Overweight

Keywords

Physical activity, mobile activity sensor and feedback system, self-management of health

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.

Interventions

DEVICEMobile 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

OTHERStandard care

Counseling on lifestyles with health education material

Sponsors

National Cheng-Kung University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Increase physical activity6 monthsMeasurement by mobile activity sensor system and the questionnaire of International Physical Activity Questionnaires (IPAQ) short form, and evaluate by counts/minute

Secondary

MeasureTime frameDescription
Increase physical fitness6 monthsMeasurement by examination of physical fitness.

Other

MeasureTime frameDescription
executive performance of participants6 monthsphysiological 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
diet record compliance3 monthsMeasurement by records of web survey

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026