One Year Observational Study on Effects of Lifestyle Intervention in Morbidly Obese Persons With Type 2 Diabetes.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Locations
- 1
- Primary Endpoint
- Health related quality of life
Study Overview
Brief Summary
There are evidence from numerous studies on effect of lifestyle intervention in morbidly obese patients with type 2 diabetes. This study examines the effect of the "Evje-model" on type 2 diabetes.
The "Evje-model" is a combined 12 months model, consisting of repeated stays in a specialist centre, telephone follow-up at home, home groups, self monitoring and close contact with the patients' local physician.
Detailed Description
There will be done QOL-measures, blood- and urine analysis, weight, waist- and hip measurement, blood pressure and VO2-max measurement at baseline, after 6 months and after 12 months.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 67 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All patients with BMI > 35 with diagnosed type 2 diabetes
- •Referred to Lifestyle Intervention from a public hospital
Exclusion Criteria
- •Pregnancy
- •Active major psychiatric disease(s)
- •Active and serious eating disorder
- •Drug- and/or alcohol dependency
Outcomes
Primary Outcomes
Health related quality of life
Time Frame: 2007
Secondary Outcomes
No secondary outcomes reported
Investigators
Tor-Ivar Karlsen
RN
Evjeklinikken
