search
Back to results

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

Primary Purpose

Metabolic Syndrome, Obesity, Overweight

Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Weight loss counseling program
Sponsored by
University of Oulu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome focused on measuring Metabolic syndrome, obesity, overweight, weight loss intervention, cognitive behavioral therapy, ICT intervention, cardiovascular disease, persuasive systems design

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • BMI 27-35

Exclusion Criteria:

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

Sites / Locations

  • Oulu University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

weight loss counseling

ELVIRA-based weight loss counseling

ICT-based weight loss counseling

Arm Description

Cognitive behavioral therapy-based weight loss counseling program including 8 group visits

Weight loss counseling program based on 2 group visits of ELVIRA counseling method

ICT-based weight loss counseling program with 52 weekly tasks and information packages.

Outcomes

Primary Outcome Measures

Weight change

Secondary Outcome Measures

Change in eating behavior
emotional eating, uncontrolled eating, cognitive restraint, binge eating symptoms

Full Information

First Posted
September 6, 2013
Last Updated
April 11, 2017
Sponsor
University of Oulu
search

1. Study Identification

Unique Protocol Identification Number
NCT01959763
Brief Title
Prevention of the Metabolic Syndrome by New Lifestyle Intervention Methods
Acronym
PrevMetSyn
Official Title
Prevention of the Metabolic Syndrome by a Lifestyle Intervention - an Application of the New Intervention Methods in the Primary Health Care.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
March 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oulu

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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 groups of different nutritional therapies with a parallel ICT-intervention group for each.
Detailed Description
The research objectives of this study: i) to find the best counseling methods for improving eating behavior (group counseling, tailored web-based counseling), ii) to find the predictors of successful lifestyle changes and weight loss, iii) to find the associations with biological and psychological eating behavior regulation system. 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 subjects with overweight or obesity and at least one risk factor of metabolic syndrome (MetSyn). A population-based sample of 600 subjects 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. At the screening 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Obesity, Overweight, Cardiovascular Disease
Keywords
Metabolic syndrome, obesity, overweight, weight loss intervention, cognitive behavioral therapy, ICT intervention, cardiovascular disease, persuasive systems design

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
574 (Actual)

8. Arms, Groups, and Interventions

Arm Title
weight loss counseling
Arm Type
Experimental
Arm Description
Cognitive behavioral therapy-based weight loss counseling program including 8 group visits
Arm Title
ELVIRA-based weight loss counseling
Arm Type
Experimental
Arm Description
Weight loss counseling program based on 2 group visits of ELVIRA counseling method
Arm Title
ICT-based weight loss counseling
Arm Type
Experimental
Arm Description
ICT-based weight loss counseling program with 52 weekly tasks and information packages.
Intervention Type
Behavioral
Intervention Name(s)
Weight loss counseling program
Other Intervention Name(s)
PrevMetSyn, Prevent Metabolic Syndrome
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight change
Time Frame
Baseline, 1 and 2 years
Secondary Outcome Measure Information:
Title
Change in eating behavior
Description
emotional eating, uncontrolled eating, cognitive restraint, binge eating symptoms
Time Frame
Baseline, 1 and 2 years
Other Pre-specified Outcome Measures:
Title
Change in metabolic syndrome related blood measures
Description
total cholesterol, HDL, LDL, Triglycerides, glucose, blood pressure
Time Frame
Baseline, 1 and 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: BMI 27-35 Exclusion Criteria: Other concurrent weight loss programs Disease which prevents weight loss Medication which affects on weight loss
Facility Information:
Facility Name
Oulu University Hospital
City
Oulu
ZIP/Postal Code
90220
Country
Finland

12. IPD Sharing Statement

Learn more about this trial

Prevention of the Metabolic Syndrome by New Lifestyle Intervention Methods

We'll reach out to this number within 24 hrs