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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Overweight and Obesity; Cardiovascular Risk Factors; Work Ability
• Intervention / Treatment: Behavioral: Weight management

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 Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Pori, Finland, 28100
    • Satakunta Heart District

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
SHAM_COMPARATOR: Nurse-lead group; 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; Please see the arm descriptions.
EXPERIMENTAL: Web-based group; 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; Please see the arm descriptions.
EXPERIMENTAL: Web-based personal; 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; Please see the arm descriptions.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Turku
• Investigators: Study Chair: Susanna Lehtimäki, Satakunta Heart District

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 4, 2018
• Primary Completion (ACTUAL): March 30, 2019
• Study Completion (ACTUAL): March 30, 2019

Study Registration Dates

• First Submitted: October 20, 2018
• First Submitted That Met QC Criteria: April 4, 2019
• First Posted (ACTUAL): April 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 4, 2020
• Last Update Submitted That Met QC Criteria: December 2, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: 10618012017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No