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

Overweight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02249611
• Other study ID #: NSC 102-2314-B-006 -004 -MY2
• Status: Completed
• Phase: N/A
• First received: September 23, 2014
• Last updated: October 7, 2015
• Start date: July 2014
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: National Cheng-Kung University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Congenital Abnormalities
• Metabolic Abnormality
• Overweight

Intervention

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

Other:
• Standard care
Counseling on lifestyles with health education material

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	diet record compliance	Measurement by records of web survey	3 months	No
Primary	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	No
Secondary	Increase physical fitness	Measurement by examination of physical fitness.	6 months	No