Overweight and ObesityPERGROUPNCT03904160
Web-based Personal or Peer Group Weight Management Study
A study testing Weight management in people with Overweight and Obesity and Cardiovascular Risk Factors, run by University of Turku at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Cardiovascular Risk Factors, Quality of Life
- What is being tested?
- Weight management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 1 siteFinland
- Study dates
- 4 Jan 2018to 30 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- body mass index 25 kg/m2 or higher
Who cannot join
- pregnancy
- active cancer
- acute cardiovascular event less than three months before
- untreated thyroid disease
- systematic corticosteroid medication
- anorexia or bulimia
- impaired communication ability
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Weight management
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight managementBehavioural
Please see the arm descriptions.
| Study group | Role | What they receive |
|---|---|---|
| Nurse-lead group | Sham comparator | 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. Receives: Behavioral: Weight management |
| Web-based group | Experimental | 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. Receives: Behavioral: Weight management |
| Web-based personal | Experimental | 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. Receives: Behavioral: Weight management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From baseline to 12 months
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: From baseline to 12 months
Change in systolic blood pressure in mmHg
Change in systolic blood pressure in mmHg
Measured: From baseline to 12 months
Change in diastolic blood pressure in mmHg
Change in diastolic blood pressure in mmHg
Measured: From baseline to 12 months
Change in waist circumference in centimeters
Change in waist circumference in centimeters
Measured: From baseline to 12 months
Change in weight in kilograms
Change in weight in kilograms
Measured: 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
Measured: From baseline to 12 months
Change in body fat percentage
Change in body fat percentage
Measured: From baseline to 12 months
Change in plasma total cholesterol in mmol/l
Change in plasma total cholesterol in mmol/l
Measured: 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
Measured: 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
Measured: From baseline to 12 months
Change in plasma triglycerides in mmol/l
Change in plasma triglycerides in mmol/l
Measured: From baseline to 12 months
Change in plasma fasting glucose in mmol/l
Change in plasma fasting glucose in mmol/l
Measured: From baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start4 Jan 2018
- Primary completion30 Mar 2019
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Päivi Korhonen, University of Turku
- Investigators
- Susanna Lehtimäki, Study chair, Satakunta Heart District
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03904160
- Sponsor's protocol ID
- 10618012017
- Acronym
- PERGROUP
- Status last verified
- Dec 2020
- First submitted
- 20 Oct 2018
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-based Personal or Peer Group Weight Management Study
- ClinicalTrials.gov ID
- NCT03904160
- Acronym / sponsor ID
- PERGROUP / 10618012017
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Study start
- 4 Jan 2018 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 5 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nurse-lead group | Sham comparator | Behavioral: Weight managementNurse-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 group | Experimental | Behavioral: Weight managementWeb-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 personal | Experimental | Behavioral: Weight managementWeb-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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- body mass index 25 kg/m2 or higher
Key exclusion criteria (7 listed)
- pregnancy
- active cancer
- acute cardiovascular event less than three months before
- untreated thyroid disease
- systematic corticosteroid medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight managementPlease see the arm descriptions. | Behavioural | Nurse-lead group, Web-based group, Web-based personal |
Primary outcome
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
The number of participants who obtained and maintained a weight loss of at least 5% at 12 months
14 secondary outcomes
Work ability
Time frame: From baseline to 12 months
Overall quality of life measured by the Eurohis instrument
Time frame: From baseline to 12 months
Health-related quality of life measured with the EuroQol instrument.
Time frame: From baseline to 12 months
Change in systolic blood pressure in mmHg
Time frame: From baseline to 12 months
Change in diastolic blood pressure in mmHg
Time frame: From baseline to 12 months
Change in waist circumference in centimeters
Time frame: From baseline to 12 months
Change in weight in kilograms
Time frame: From baseline to 12 months
Change in body mass index.
Time frame: From baseline to 12 months
Change in body fat percentage
Time frame: From baseline to 12 months
Change in plasma total cholesterol in mmol/l
Time frame: From baseline to 12 months
Change in plasma high-density lipoprotein cholesterol in mmol/l
Time frame: From baseline to 12 months
Change in plasma low-density lipoprotein cholesterol in mmol/l
Time frame: From baseline to 12 months
Change in plasma triglycerides in mmol/l
Time frame: From baseline to 12 months
Change in plasma fasting glucose in mmol/l
Time frame: From baseline to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanna Lehtimäki study chair
Satakunta Heart District
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight management in people with Overweight and Obesity and Cardiovascular Risk Factors, run by University of Turku at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2020.