NCT03904160

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 5, 2019

Completed
Last Updated

December 4, 2020

Status Verified

December 1, 2020

Enrollment Period

1.2 years

First QC Date

October 20, 2018

Last Update Submit

December 2, 2020

Conditions

Overweight and ObesityCardiovascular Risk FactorsQuality of LifeWork Ability

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (14)

  • Work ability

    From baseline to 12 months

  • Overall quality of life measured by the Eurohis instrument

    From baseline to 12 months

  • Health-related quality of life measured with the EuroQol instrument.

    From baseline to 12 months

  • Change in systolic blood pressure in mmHg

    From baseline to 12 months

  • Change in diastolic blood pressure in mmHg

    From baseline to 12 months

  • +9 more secondary outcomes

Study Arms (3)

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.

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.

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.

Behavioral: Weight management

Interventions

Weight managementBEHAVIORAL

Please see the arm descriptions.

Nurse-lead groupWeb-based groupWeb-based personal

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipant eligibility is based on self-representation of gender identity.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • body mass index 25 kg/m2 or higher

You may not qualify if:

  • pregnancy
  • active cancer
  • acute cardiovascular event less than three months before
  • untreated thyroid disease
  • systematic corticosteroid medication
  • anorexia or bulimia
  • impaired communication ability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Satakunta Heart District

Pori, 28100, Finland

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Susanna Lehtimäki

    Satakunta Heart District

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of General Practice

Study Record Dates

First Submitted

October 20, 2018

First Posted

April 5, 2019

Study Start

January 4, 2018

Primary Completion

March 30, 2019

Study Completion

March 30, 2019

Last Updated

December 4, 2020

Record last verified: 2020-12

Locations

FI(1)