Web-based Personal or Peer Group Weight Management Study

Quality of Life Clinical Trial

— PERGROUP  

Official title:

Web-based Personal or Peer Group Weight Management Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03904160
• Other study ID #: 10618012017
• Status: Completed
• Phase: N/A
• Start date: January 4, 2018
• Est. completion date: March 30, 2019

Study information

• Verified date: December 2020
• Source: University of Turku
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The control group is the traditional nurse-lead weight management group counselling.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cardiovascular Risk Factors
• Overweight
• Overweight and Obesity
• Quality of Life
• Work Ability

Intervention

Behavioral:
• Weight management
Please see the arm descriptions.

Locations

Country	Name	City	State
Finland	Satakunta Heart District	Pori

Sponsors (1)

Lead Sponsor	Collaborator
University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

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