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Web-based Personal or Peer Group Weight Management Study

NCT ID: NCT03904160

Last Updated: 2020-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-04

Study Completion Date

2019-03-30

Brief Summary

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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

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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.

Conditions

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Overweight and Obesity Cardiovascular Risk Factors Quality of Life Work Ability

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type SHAM_COMPARATOR

Weight management

Intervention Type BEHAVIORAL

Please see the arm descriptions.

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.

Group Type EXPERIMENTAL

Weight management

Intervention Type BEHAVIORAL

Please see the arm descriptions.

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.

Group Type EXPERIMENTAL

Weight management

Intervention Type BEHAVIORAL

Please see the arm descriptions.

Interventions

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Weight management

Please see the arm descriptions.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Turku

OTHER

Sponsor Role lead

Responsible Party

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Päivi Korhonen

Professor of General Practice

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susanna Lehtimäki

Role: STUDY_CHAIR

Satakunta Heart District

Locations

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Satakunta Heart District

Pori, , Finland

Site Status

Countries

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Finland

Other Identifiers

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10618012017

Identifier Type: -

Identifier Source: org_study_id