Prevention of the Metabolic Syndrome by New Lifestyle Intervention Methods (PrevMetSyn)

October 28, 2024 updated by: University of Oulu

Prevention of the Metabolic Syndrome by a Lifestyle Intervention - an Application of the New Intervention Methods in the Primary Health Care.

This intervention aims to reduce obesity by using new type of nutritional and lifestyle therapy and in parallel, tailored persuasive information and communications technology (ICT)-technology based application. The study hypothesis is that obesity cannot be reduced just by distributing nutritional information. Instead, by influencing also the eating behavior, permanent lifestyle changes can be achieved. The effect of the therapy along the time-line, the health information literacy of the study persons and the changes in it will be studied at different phases of the intervention. The research will be carried out in three main groups of different levels of nutritional therapies with a parallel ICT-intervention and control group for each main group (altogether six groups).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The research objectives of this study: 1) to find the best counseling methods for improving eating behavior (group counseling, tailored web-based counseling), 2) to find the predictors of successful lifestyle changes and weight loss, 3) to find the associations with biological and psychological eating behavior regulation system, 4) to study the long-term effects of the intervention, 5) to investigate the changes to the medications after the intervention . The study hypothesis is that new theoretically valid cognitive-behavioral-therapy -based counseling methods in combination with ICT support based on persuasive design improve eating behavior, weight loss and self-efficacy and reduce risk factors for the metabolic syndrome, type 2 diabetes, coronary heart disease and musculoskeletal factors.

The study population consists of participants with overweight or obesity and at least one risk factor of metabolic syndrome (MetSyn). A population-based sample of 600 participants living in the Oulu area (approx. 200 000 habitants) is collected with the help of the Finnish Population Register Centre.

Inclusion criteria include also the ability to use basic ICT technology (email etc.). Exclusion criteria are certain uncontrolled health factors, such as abnormal laboratory values (thyroid, kidney and liver function tests) or clinically significant illness with contraindication for weight loss or physical activity.

Study visits are at baseline, 1, 2 and 5 years. At the study visit blood samples are drawn at the research laboratory of the Oulu University Hospital. Along with the timeline of the visits the eating behaviour factors (emotional eating, uncontrolled eating and cognitive restraint), health information literacy (HIL), nutrition habits, smoking, alcohol consumption, medication and previous diseases are recorded by a detailed questionnaires sent to study persons by e-mail. The blood pressure, waist diameter, height and weight are also measured during the visit. All the operations have been described in detail and accepted by the regional Ethics Committee of the Northern Ostrobothnia.

The randomization process is two-phased. First the subjects who are included in the study are randomized into 2 different kinds of lifestyle face-to-face counselling groups and one control group. After that they are randomized into users or non-users of the web-based ICT-program "Onnikka". As a summary, there are six different counselling groups: 1) Intensive group counselling, 2) Intensive group counselling with Onnikka, 3) Short term group counselling, 4) Short term counselling with Onnikka, 5) Control group (no intervention at all), and 6) Only Onnikka.

A linear mixed-effect model (LMM) (as primary analysis), where group (six study arms) and time were fixed effect factors are used to examine the differences in weight from baseline to 1, 2 and 5 years adjusting for age and sex. Primary analysis and sensitivity analyses are based on intention-to-treat principles. Primary analysis are also used to examine the differences between ICT groups and non-ICT groups. Group and time interaction are included in the model to examine whether mean change over time is different between groups. If data include missing values, they will be assumed to be completely at random. The same model is used with imputed values (both last observation carried forward (LOCF) and return-to-baseline (RTB) where data are missing and for completers as sensitivity analyses. Area Under the Curve (AUC) analysis is performed to integrate the effect interventions on the weight reduction over the different time points.

Study Type

Interventional

Enrollment (Actual)

574

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Oulu, Finland, 90220
        • Oulu University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • BMI 27-35

Exclusion Criteria:

  • Other concurrent weight loss programs
  • Disease which prevents weight loss
  • Medication which affects on weight loss

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ICT-based weight loss counseling
ICT-based weight loss counseling program with 52 weekly tasks and information packages.
Behavioral: Weight loss counseling program
Randomized study persons are given either one of the two different methods of weight loss counseling program without ICT or with ICT-based counseling. As a control for the study groups one group is receiving only ICT-based counseling and one group does not receive any of the counseling methods.
Other Names:
  • PrevMetSyn, Prevent Metabolic Syndrome
Experimental: Weight loss counseling with ICT intervention
Cognitive behavioral therapy-based weight loss counseling program including 8 group visits. Participant have also persuasive ICT support.
Behavioral: Weight loss counseling program
Randomized study persons are given either one of the two different methods of weight loss counseling program without ICT or with ICT-based counseling. As a control for the study groups one group is receiving only ICT-based counseling and one group does not receive any of the counseling methods.
Other Names:
  • PrevMetSyn, Prevent Metabolic Syndrome
Experimental: Weigth loss counseling
Cognitive behavioral therapy-based weight loss counseling program including 8 group visits.
Behavioral: Weight loss counseling program
Randomized study persons are given either one of the two different methods of weight loss counseling program without ICT or with ICT-based counseling. As a control for the study groups one group is receiving only ICT-based counseling and one group does not receive any of the counseling methods.
Other Names:
  • PrevMetSyn, Prevent Metabolic Syndrome
Experimental: ELVIRA-based weight loss counseling with ICT intervention
Weight loss counseling program based on 2 group visits of ELVIRA counseling method. Participant have also persuasive ICT support.
Behavioral: Weight loss counseling program
Randomized study persons are given either one of the two different methods of weight loss counseling program without ICT or with ICT-based counseling. As a control for the study groups one group is receiving only ICT-based counseling and one group does not receive any of the counseling methods.
Other Names:
  • PrevMetSyn, Prevent Metabolic Syndrome
Experimental: ELVIRA-based weight loss counseling
Weight loss counseling program based on 2 group visits of ELVIRA counseling method.
Behavioral: Weight loss counseling program
Randomized study persons are given either one of the two different methods of weight loss counseling program without ICT or with ICT-based counseling. As a control for the study groups one group is receiving only ICT-based counseling and one group does not receive any of the counseling methods.
Other Names:
  • PrevMetSyn, Prevent Metabolic Syndrome
Experimental: Control group
Usual care without any interventions.
Behavioral: Weight loss counseling program
Randomized study persons are given either one of the two different methods of weight loss counseling program without ICT or with ICT-based counseling. As a control for the study groups one group is receiving only ICT-based counseling and one group does not receive any of the counseling methods.
Other Names:
  • PrevMetSyn, Prevent Metabolic Syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight change
Time Frame: Baseline, 1 , 2 and 5 years
Baseline, 1 , 2 and 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in eating behavior
Time Frame: Baseline, 1, 2 and 5 years
emotional eating, uncontrolled eating, cognitive restraint, binge eating symptoms
Baseline, 1, 2 and 5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in metabolic syndrome related blood measures
Time Frame: Baseline, 1, 2 and 5 years
total cholesterol, HDL, LDL, Triglycerides, glucose, blood pressure
Baseline, 1, 2 and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oulu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

December 1, 2019

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

September 6, 2013

First Submitted That Met QC Criteria

October 9, 2013

First Posted (Estimated)

October 10, 2013

Study Record Updates

Last Update Posted (Actual)

October 31, 2024

Last Update Submitted That Met QC Criteria

October 28, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 55/2012
  • 083/THL/TE/2012 (Other Grant/Funding Number: The institute of health and welfare, Finland)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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