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Web-based Personal or Peer Group Weight Management Study (PERGROUP)

Primary Purpose

Overweight and Obesity, Cardiovascular Risk Factors, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Weight management
Sponsored by
University of Turku
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Overweight and Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Satakunta Heart District

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Experimental

Experimental

Arm Label

Nurse-lead group

Web-based group

Web-based personal

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
Change in systolic blood pressure in mmHg
Change in systolic blood pressure in mmHg
Change in diastolic blood pressure in mmHg
Change in diastolic blood pressure in mmHg
Change in waist circumference in centimeters
Change in waist circumference in centimeters
Change in weight in kilograms
Change in weight in kilograms
Change in body mass index.
Change in body mass index. Weight and height will be combined to report body mass index in kg/m2
Change in body fat percentage
Change in body fat percentage
Change in plasma total cholesterol in mmol/l
Change in plasma total cholesterol in mmol/l
Change in plasma high-density lipoprotein cholesterol in mmol/l
Change in plasma high-density lipoprotein cholesterol in mmol/l
Change in plasma low-density lipoprotein cholesterol in mmol/l
Change in plasma low-density lipoprotein cholesterol in mmol/l
Change in plasma triglycerides in mmol/l
Change in plasma triglycerides in mmol/l
Change in plasma fasting glucose in mmol/l
Change in plasma fasting glucose in mmol/l

Full Information

First Posted
October 20, 2018
Last Updated
December 2, 2020
Sponsor
University of Turku
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1. Study Identification

Unique Protocol Identification Number
NCT03904160
Brief Title
Web-based Personal or Peer Group Weight Management Study
Acronym
PERGROUP
Official Title
Web-based Personal or Peer Group Weight Management Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 4, 2018 (Actual)
Primary Completion Date
March 30, 2019 (Actual)
Study Completion Date
March 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turku

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Cardiovascular Risk Factors, Quality of Life, Work Ability

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nurse-lead group
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Web-based group
Arm Type
Experimental
Arm Description
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.
Arm Title
Web-based personal
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Weight management
Intervention Description
Please see the arm descriptions.
Primary Outcome Measure Information:
Title
The number of participants who obtained and maintained a weight loss of at least 5% at 12 months
Description
The number of participants who obtained and maintained a weight loss of at least 5% at 12 months
Time Frame
From baseline to 12 months
Secondary Outcome Measure Information:
Title
Work ability
Description
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.
Time Frame
From baseline to 12 months
Title
Overall quality of life measured by the Eurohis instrument
Description
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.
Time Frame
From baseline to 12 months
Title
Health-related quality of life measured with the EuroQol instrument.
Description
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.
Time Frame
From baseline to 12 months
Title
Change in systolic blood pressure in mmHg
Description
Change in systolic blood pressure in mmHg
Time Frame
From baseline to 12 months
Title
Change in diastolic blood pressure in mmHg
Description
Change in diastolic blood pressure in mmHg
Time Frame
From baseline to 12 months
Title
Change in waist circumference in centimeters
Description
Change in waist circumference in centimeters
Time Frame
From baseline to 12 months
Title
Change in weight in kilograms
Description
Change in weight in kilograms
Time Frame
From baseline to 12 months
Title
Change in body mass index.
Description
Change in body mass index. Weight and height will be combined to report body mass index in kg/m2
Time Frame
From baseline to 12 months
Title
Change in body fat percentage
Description
Change in body fat percentage
Time Frame
From baseline to 12 months
Title
Change in plasma total cholesterol in mmol/l
Description
Change in plasma total cholesterol in mmol/l
Time Frame
From baseline to 12 months
Title
Change in plasma high-density lipoprotein cholesterol in mmol/l
Description
Change in plasma high-density lipoprotein cholesterol in mmol/l
Time Frame
From baseline to 12 months
Title
Change in plasma low-density lipoprotein cholesterol in mmol/l
Description
Change in plasma low-density lipoprotein cholesterol in mmol/l
Time Frame
From baseline to 12 months
Title
Change in plasma triglycerides in mmol/l
Description
Change in plasma triglycerides in mmol/l
Time Frame
From baseline to 12 months
Title
Change in plasma fasting glucose in mmol/l
Description
Change in plasma fasting glucose in mmol/l
Time Frame
From baseline to 12 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Participant eligibility is based on self-representation of gender identity.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanna Lehtimäki
Organizational Affiliation
Satakunta Heart District
Official's Role
Study Chair
Facility Information:
Facility Name
Satakunta Heart District
City
Pori
ZIP/Postal Code
28100
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Web-based Personal or Peer Group Weight Management Study

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