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

NCT02249611 | Completed DMC

• 1 other identifier: NSC 102-2314-B-006 -004 -MY2
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Metabolic Abnormality

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Increase physical fitness

  6 months

Other Outcomes (2)

• executive performance of participants

  6 months

• diet record compliance

  3 months

Study Arms (2)

MT and life counseling

EXPERIMENTAL

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

Standard care

ACTIVE COMPARATOR

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

Interventions

Mobile physical activity promotion tool 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

MT and life counseling

Standard care OTHER

Counseling on lifestyles with health education material

Also known as: Counseling on lifestyles

Standard care

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University

Tainan, 701, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 28729003 DERIVED

MeSH Terms

Conditions

Overweight; Motor Activity

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Yi Ching Yang, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, professor

Study Record Dates

• First Submitted: September 23, 2014
• First Posted: September 25, 2014
• Study Start: July 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 9, 2015

Record last verified: 2015-10

Locations

TW (1)