PERGROUP: Web-based Personal or Peer Group Weight Management Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
In this study, efficacy of two web-based weight management systems will be compared to a traditional nurse-lead sessions for weight management.
Ten nurse-lead group counselling sessions lasting 90 minutes each will be conducted in three groups of 10-14 participants. Each session comprise education about healthy diet, psychoeducation and discussions.
The web-based group counselling program offers informative weight management system with peer-based conversation possibility. Three groups of 10-14 participants who gather together for three nurse-lead sessions in the weeks 0, 5, and 12. The web-based program can be used for a year.
The web-based personal counselling program offers informative weight management system with conversation possibility with the nurse for 12 weeks. Altogether 37 participants are enrolled and they can use the web-based weight management system for one year.
In each intervention arm, intervention and counselling provided by the study nurses last for three months. Among all participants, weight loss, cardiometabolic data, information of lifestyle and quality of life will be measured at baseline, after the nurse-lead intervention (three months) and 12 months from the baseline.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Sham Comparator: Nurse-lead group Nurse-lead sessions for weight management. Ten sessions lasting 90 minutes each in three groups of 10-14 participants. Each session comprise education about healthy diet, psychoeducation and discussions. |
Behavioral: Weight management
Please see the arm descriptions.
|
| Experimental: Web-based group Web-based weight management system with peer-based conversation possibility. Three groups of 10-14 participants who gather together for three nurse-lead sessions in the weeks 0, 5, and 12. The web-based program can be used for a year. |
Behavioral: Weight management
Please see the arm descriptions.
|
| Experimental: Web-based personal Web-based weight management system with conversation possibility with the nurse for 12 weeks. Altogether 37 participants who can use the web-based weight management system for one year. |
Behavioral: Weight management
Please see the arm descriptions.
|
Outcome Measures
Primary Outcome Measures
- The number of participants who obtained and maintained a weight loss of at least 5% at 12 months [From baseline to 12 months]
The number of participants who obtained and maintained a weight loss of at least 5% at 12 months
Secondary Outcome Measures
- Work ability [From baseline to 12 months]
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.
- Overall quality of life measured by the Eurohis instrument [From baseline to 12 months]
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.
- Health-related quality of life measured with the EuroQol instrument. [From baseline to 12 months]
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.
- Change in systolic blood pressure in mmHg [From baseline to 12 months]
Change in systolic blood pressure in mmHg
- Change in diastolic blood pressure in mmHg [From baseline to 12 months]
Change in diastolic blood pressure in mmHg
- Change in waist circumference in centimeters [From baseline to 12 months]
Change in waist circumference in centimeters
- Change in weight in kilograms [From baseline to 12 months]
Change in weight in kilograms
- Change in body mass index. [From baseline to 12 months]
Change in body mass index. Weight and height will be combined to report body mass index in kg/m2
- Change in body fat percentage [From baseline to 12 months]
Change in body fat percentage
- Change in plasma total cholesterol in mmol/l [From baseline to 12 months]
Change in plasma total cholesterol in mmol/l
- Change in plasma high-density lipoprotein cholesterol in mmol/l [From baseline to 12 months]
Change in plasma high-density lipoprotein cholesterol in mmol/l
- Change in plasma low-density lipoprotein cholesterol in mmol/l [From baseline to 12 months]
Change in plasma low-density lipoprotein cholesterol in mmol/l
- Change in plasma triglycerides in mmol/l [From baseline to 12 months]
Change in plasma triglycerides in mmol/l
- Change in plasma fasting glucose in mmol/l [From baseline to 12 months]
Change in plasma fasting glucose in mmol/l
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Satakunta Heart District | Pori | Finland | 28100 |
Sponsors and Collaborators
- University of Turku
Investigators
- Study Chair: Susanna Lehtimäki, Satakunta Heart District
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 10618012017