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Completed

NCT Number: NCT03904160

Web-based Personal or Peer Group Weight Management Study

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.

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Key information

Conditions

Overweight and Obesity Body Weight Cardiovascular Risk Factors Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Quality of Life Signs and Symptoms Work Ability

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Satakunta Heart District

Pori, 28100, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Weight management

Behavioral

Please see the arm descriptions.

Primary outcomes

  1. The number of participants who obtained and maintained a weight loss of at least 5% at 12 months

    Time frame: From baseline to 12 months

    The number of participants who obtained and maintained a weight loss of at least 5% at 12 months

Secondary outcomes

  1. Work ability

    Time frame: From baseline to 12 months

    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.

  2. Overall quality of life measured by the Eurohis instrument

    Time frame: From baseline to 12 months

    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.

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

    Time frame: From baseline to 12 months

    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.

  4. Change in systolic blood pressure in mmHg

    Time frame: From baseline to 12 months

    Change in systolic blood pressure in mmHg

  5. Change in diastolic blood pressure in mmHg

    Time frame: From baseline to 12 months

    Change in diastolic blood pressure in mmHg

  6. Change in waist circumference in centimeters

    Time frame: From baseline to 12 months

    Change in waist circumference in centimeters

  7. Change in weight in kilograms

    Time frame: From baseline to 12 months

    Change in weight in kilograms

  8. Change in body mass index.

    Time frame: From baseline to 12 months

    Change in body mass index. Weight and height will be combined to report body mass index in kg/m2

  9. Change in body fat percentage

    Time frame: From baseline to 12 months

    Change in body fat percentage

  10. Change in plasma total cholesterol in mmol/l

    Time frame: From baseline to 12 months

    Change in plasma total cholesterol in mmol/l

  11. Change in plasma high-density lipoprotein cholesterol in mmol/l

    Time frame: From baseline to 12 months

    Change in plasma high-density lipoprotein cholesterol in mmol/l

  12. Change in plasma low-density lipoprotein cholesterol in mmol/l

    Time frame: From baseline to 12 months

    Change in plasma low-density lipoprotein cholesterol in mmol/l

  13. Change in plasma triglycerides in mmol/l

    Time frame: From baseline to 12 months

    Change in plasma triglycerides in mmol/l

  14. Change in plasma fasting glucose in mmol/l

    Time frame: From baseline to 12 months

    Change in plasma fasting glucose in mmol/l

Sponsors and collaborators

Lead sponsor

University of Turku

Other

Registry information

Acronym: PERGROUP

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 5, 2019
Registry last updated
Dec 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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