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

11. april 2017 opdateret af: 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 groups of different nutritional therapies with a parallel ICT-intervention group for each.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

574

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Oulu, Finland, 90220
        • Oulu University Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år til 60 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • BMI 27-35

Exclusion Criteria:

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Faktoriel opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: weight loss counseling
Cognitive behavioral therapy-based weight loss counseling program including 8 group visits
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.
Andre navne:
  • PrevMetSyn, Prevent Metabolic Syndrome
Eksperimentel: ELVIRA-based weight loss counseling
Weight loss counseling program based on 2 group visits of ELVIRA counseling method
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.
Andre navne:
  • PrevMetSyn, Prevent Metabolic Syndrome
Eksperimentel: ICT-based weight loss counseling
ICT-based weight loss counseling program with 52 weekly tasks and information packages.
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.
Andre navne:
  • PrevMetSyn, Prevent Metabolic Syndrome

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Weight change
Tidsramme: Baseline, 1 and 2 years
Baseline, 1 and 2 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in eating behavior
Tidsramme: Baseline, 1 and 2 years
emotional eating, uncontrolled eating, cognitive restraint, binge eating symptoms
Baseline, 1 and 2 years

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in metabolic syndrome related blood measures
Tidsramme: Baseline, 1 and 2 years
total cholesterol, HDL, LDL, Triglycerides, glucose, blood pressure
Baseline, 1 and 2 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2013

Primær færdiggørelse (Forventet)

1. marts 2019

Studieafslutning (Forventet)

1. marts 2019

Datoer for studieregistrering

Først indsendt

6. september 2013

Først indsendt, der opfyldte QC-kriterier

9. oktober 2013

Først opslået (Skøn)

10. oktober 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. april 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. april 2017

Sidst verificeret

1. april 2017

Mere information

Begreber relateret til denne undersøgelse

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Weight loss counseling program

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