Quality of Life Clinical Trial
— PERGROUPOfficial title:
Web-based Personal or Peer Group Weight Management Study
Verified date | December 2020 |
Source | University of Turku |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The PERGROUP trial aims to investigate whether Web-based personal or Web-based group counselling weight management program can help to achieve lifestyle changes needed for weight loss and improvement in quality of life and cardiovascular risk factors. The control group is the traditional nurse-lead weight management group counselling.
Status | Completed |
Enrollment | 109 |
Est. completion date | March 30, 2019 |
Est. primary completion date | March 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - body mass index 25 kg/m2 or higher Exclusion Criteria: - pregnancy - active cancer - acute cardiovascular event less than three months before - untreated thyroid disease - systematic corticosteroid medication - anorexia or bulimia - impaired communication ability |
Country | Name | City | State |
---|---|---|---|
Finland | Satakunta Heart District | Pori |
Lead Sponsor | Collaborator |
---|---|
University of Turku |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The number of participants who obtained and maintained a weight loss of at least 5% at 12 months | The number of participants who obtained and maintained a weight loss of at least 5% at 12 months | From baseline to 12 months | |
Secondary | Work ability | The percentage of participants in whom weight management intervention will be associated with participants´ Work Ability Score (WAS). The total score range is 0 to 10 with higher value representing better work ability. | From baseline to 12 months | |
Secondary | Overall quality of life measured by the Eurohis instrument | The number of participants in whom weight management intervention will be associated with quality of life assessed by the Eurohis instrument. Mean change from baseline in frequencies of reported problems will be reported. | From baseline to 12 months | |
Secondary | Health-related quality of life measured with the EuroQol instrument. | The number of participants in whom weight management intervention will be associated with quality of life assessed by the EuroQol instrument. Mean change from baseline in frequencies of reported problems will be reported. | From baseline to 12 months | |
Secondary | Change in systolic blood pressure in mmHg | Change in systolic blood pressure in mmHg | From baseline to 12 months | |
Secondary | Change in diastolic blood pressure in mmHg | Change in diastolic blood pressure in mmHg | From baseline to 12 months | |
Secondary | Change in waist circumference in centimeters | Change in waist circumference in centimeters | From baseline to 12 months | |
Secondary | Change in weight in kilograms | Change in weight in kilograms | From baseline to 12 months | |
Secondary | Change in body mass index. | Change in body mass index. Weight and height will be combined to report body mass index in kg/m2 | From baseline to 12 months | |
Secondary | Change in body fat percentage | Change in body fat percentage | From baseline to 12 months | |
Secondary | Change in plasma total cholesterol in mmol/l | Change in plasma total cholesterol in mmol/l | From baseline to 12 months | |
Secondary | Change in plasma high-density lipoprotein cholesterol in mmol/l | Change in plasma high-density lipoprotein cholesterol in mmol/l | From baseline to 12 months | |
Secondary | Change in plasma low-density lipoprotein cholesterol in mmol/l | Change in plasma low-density lipoprotein cholesterol in mmol/l | From baseline to 12 months | |
Secondary | Change in plasma triglycerides in mmol/l | Change in plasma triglycerides in mmol/l | From baseline to 12 months | |
Secondary | Change in plasma fasting glucose in mmol/l | Change in plasma fasting glucose in mmol/l | From baseline to 12 months |
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