NCT00398060

Brief Summary

Life-style change achieved in controlled experimental condition has been shown to prevent type 2 diabetes. The purpose of this study is to evaluate to what extent the life-style change can be achieved in a routine health care setting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
389

participants targeted

Target at P50-P75 for phase_3 obesity

Timeline
Completed

Started Jan 2003

Longer than P75 for phase_3 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 10, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

February 14, 2008

Status Verified

February 1, 2008

Enrollment Period

1.9 years

First QC Date

November 9, 2006

Last Update Submit

February 13, 2008

Conditions

ObesityType 2 Diabetes

Keywords

life-style counselingtype 2 diabetesprediabetesphysical activitydietcognitive-behavioral

Outcome Measures

Primary Outcomes (3)

  • Nutrition (fat, fiber)

    0-1 years

  • Physical activity

    0-3 years

  • Weight

    0-3 years

Secondary Outcomes (4)

  • Waist circumference

    0-3 years

  • Plasma glucose (fasting, 2 hr challenge)

    0-3 years

  • Serum lipids

    0-3 years

  • Blood pressure (diastolic, systolic)

    0-3 years

Study Arms (1)

A

EXPERIMENTAL
Behavioral: Cognitive-behavioral life-style counseling

Interventions

Cognitive-behavioral life-style counselingBEHAVIORAL
A

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes risk test score \> 11 (Lindstrom \& Tuomilehto, 2003)

You may not qualify if:

  • mental health problem or substance abuse likely to interfere with participation
  • acute cancer
  • type 2 diabetes requiring pharmacological treatment
  • myocardial infarction during the past six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Päijät-Häme Hospital District

Lahti, 15850, Finland

Location

Related Publications (1)

  • Uutela A, Absetz P, Nissinen A, Valve R, Talja M, Fogelholm M. Health psychological theory in promoting population health in Paijat-Hame, Finland: first steps toward a type 2 diabetes prevention study. J Health Psychol. 2004 Jan;9(1):73-84. doi: 10.1177/1359105304036103.

    PMID: 14683570BACKGROUND

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2Prediabetic StateMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesBehavior

Study Officials

  • Antti Uutela, PhD

    National Public Health Institute

    STUDY DIRECTOR

  • Pilvikki Absetz, PhD

    National Public Health Institute

    PRINCIPAL INVESTIGATOR

  • Martti Talja, PhD

    Päijät Häme Central Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 9, 2006

First Posted

November 10, 2006

Study Start

January 1, 2003

Primary Completion

December 1, 2004

Study Completion

March 1, 2007

Last Updated

February 14, 2008

Record last verified: 2008-02

Locations

FI(1)