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Completed

NCT Number: NCT02249611

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

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.

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng Kung University

Tainan, 701, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mobile physical activity promotion tool

Device
  • 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

Standard care

Other

Counseling on lifestyles with health education material

Other names: Counseling on lifestyles

Primary outcomes

  1. Increase physical activity

    Time frame: 6 months

    Measurement by mobile activity sensor system and the questionnaire of International Physical Activity Questionnaires (IPAQ) short form, and evaluate by counts/minute

Secondary outcomes

  1. Increase physical fitness

    Time frame: 6 months

    Measurement by examination of physical fitness.

Other outcomes

  1. executive performance of participants

    Time frame: 6 months

    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

  2. diet record compliance

    Time frame: 3 months

    Measurement by records of web survey

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 25, 2014
Registry last updated
Oct 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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