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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03904160
Other study ID # 10618012017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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