Overview

This trial is active, not recruiting.

Condition overweight
Treatment support for increased physical activity
Sponsor Karolinska Institutet
Collaborator Stockholm County Council, Sweden
Start date October 2006
End date April 2010
Trial size 234 participants
Trial identifier NCT00747942, S-1165

Summary

The purpose of this study is to improve and analyze the level of physical activity in immigrant women from the Middle East and Latin America living in Sweden. The investigators will also investigate if glucose, insulin, and lipid metabolism; stress-related hormone production; and subclinical inflammatory activity are affected by the intervention. The follow-up period is 2 years.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(No Intervention)
exercise referral to lifestyle activities at the level of moderate intensity without support
(Active Comparator)
Exercise referral combined with individual support, access to structured group exercise programs, and motivational support
support for increased physical activity STAM
Exercise referral combined with individual support, access to structured group exercise programs, and motivational support

Primary Outcomes

Measure
The relative effectiveness of two physical activity programs in affecting glucose metabolism, lipid metabolism and stress-related hormone production
time frame: 2 years

Eligibility Criteria

Female participants from 25 years up to 64 years old.

Inclusion Criteria: - Female gender - Age 25 through 64 years - Physical inactivity - BMI > 25 - Immigrant to Sweden from either the Middle East or Latin America Exclusion Criteria: - Diabetes mellitus type I - Ischemic heart disease - Disability that interferes with the ability to participate in lifestyle-related physical activity

Additional Information

Official title Intervention Program for Physically Inactive and Overweight Immigrant Women From the Middle East and Latin America Living in Sweden
Trial information was received from ClinicalTrials.gov and was last updated in September 2008.
Information provided to ClinicalTrials.gov by Karolinska Institutet.