Web-based Personal or Peer Group Weight Management Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Web-based Personal or Peer Group Weight Management Study

Conditions
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Overweight and Obesity, Cardiovascular Risk Factors, Quality of Life, Work Ability

Intervention / Treatment
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* Behavioral: Weight management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Nurse-lead group<br>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<br>* Please see the arm descriptions.<br>|
| Experimental: Web-based group<br>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<br>* Please see the arm descriptions.<br>|
| Experimental: Web-based personal<br>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<br>* Please see the arm descriptions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Change in systolic blood pressure in mmHg | Change in systolic blood pressure in mmHg | From baseline to 12 months | 
| Change in diastolic blood pressure in mmHg | Change in diastolic blood pressure in mmHg | From baseline to 12 months | 
| Change in waist circumference in centimeters | Change in waist circumference in centimeters | From baseline to 12 months | 
| Change in weight in kilograms | Change in weight in kilograms | From baseline to 12 months | 
| 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 | 
| Change in body fat percentage | Change in body fat percentage | From baseline to 12 months | 
| Change in plasma total cholesterol in mmol/l | Change in plasma total cholesterol in mmol/l | From baseline to 12 months | 
| 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 | 
| 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 | 
| Change in plasma triglycerides in mmol/l | Change in plasma triglycerides in mmol/l | From baseline to 12 months | 
| Change in plasma fasting glucose in mmol/l | Change in plasma fasting glucose in mmol/l | From baseline to 12 months |