Overview

This trial is active, not recruiting.

Conditions metabolic syndrome,, obesity,, overweight,, cardiovascular disease
Treatment weight loss counseling program
Sponsor University of Oulu
Start date February 2013
End date March 2019
Trial size 574 participants
Trial identifier NCT01959763, 083/THL/TE/2012, 55/2012

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Cognitive behavioral therapy-based weight loss counseling program including 8 group visits
weight loss counseling program PrevMetSyn, Prevent Metabolic Syndrome
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.
(Experimental)
Weight loss counseling program based on 2 group visits of ELVIRA counseling method
weight loss counseling program PrevMetSyn, Prevent Metabolic Syndrome
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.
(Experimental)
ICT-based weight loss counseling program with 52 weekly tasks and information packages.
weight loss counseling program PrevMetSyn, Prevent Metabolic Syndrome
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 Outcomes

Measure
Weight change
time frame: Baseline, 1 and 2 years

Secondary Outcomes

Measure
Change in eating behavior
time frame: Baseline, 1 and 2 years

Eligibility Criteria

Male or female participants from 20 years up to 60 years old.

Inclusion Criteria: - BMI 27-35 Exclusion Criteria: - Other concurrent weight loss programs - Disease which prevents weight loss - Medication which affects on weight loss

Additional Information

Official title Prevention of the Metabolic Syndrome by a Lifestyle Intervention - an Application of the New Intervention Methods in the Primary Health Care.
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by University of Oulu.