Clinical trial NCT03904160: Web-based Personal or Peer Group Weight Management Study
Official title: Web-based Personal or Peer Group Weight Management Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Cardiovascular Risk Factors
Quality of Life
Work Ability
Lead sponsor: University of Turku
Sponsor class: OTHER
First posted: 2019-04-05
Enrollment: 109
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The number of participants who obtained and maintained a weight loss of at least 5% at 12 months
timeFrame: From baseline to 12 months
Secondary outcomes:
measure: Work ability
timeFrame: From baseline to 12 months
measure: Overall quality of life measured by the Eurohis instrument
timeFrame: From baseline to 12 months
measure: Health-related quality of life measured with the EuroQol instrument.
timeFrame: From baseline to 12 months
measure: Change in systolic blood pressure in mmHg
timeFrame: From baseline to 12 months
measure: Change in diastolic blood pressure in mmHg
timeFrame: From baseline to 12 months
measure: Change in waist circumference in centimeters
timeFrame: From baseline to 12 months
measure: Change in weight in kilograms
timeFrame: From baseline to 12 months
measure: Change in body mass index.
timeFrame: From baseline to 12 months
measure: Change in body fat percentage
timeFrame: From baseline to 12 months
measure: Change in plasma total cholesterol in mmol/l
timeFrame: From baseline to 12 months
measure: Change in plasma high-density lipoprotein cholesterol in mmol/l
timeFrame: From baseline to 12 months
measure: Change in plasma low-density lipoprotein cholesterol in mmol/l
timeFrame: From baseline to 12 months
measure: Change in plasma triglycerides in mmol/l
timeFrame: From baseline to 12 months
measure: Change in plasma fasting glucose in mmol/l
timeFrame: From baseline to 12 months
Other outcomes:
Locations:
city: Pori
country: Finland
facility: Satakunta Heart District
Study officials:
affiliation: Satakunta Heart District
name: Susanna Lehtimäki
role: STUDY_CHAIR
References: