Clincosm LogoSign in Get a demo

STAM: Support for Increased Physical Activity (Stöd Till Aktivare Motion)

Sponsor
Karolinska Institutet (Other)
Overall Status
Completed
CT.gov ID
NCT00747942
Collaborator
Region Stockholm (Other)
234
Enrollment
1
Location
2
Arms
42
Duration (Months)
5.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Support for Increased Physical Activity
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
234 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Intervention Program for Physically Inactive and Overweight Immigrant Women From the Middle East and Latin America Living in Sweden
Study Start Date :
Oct 1, 2006
Actual Primary Completion Date :
Apr 1, 2010
Actual Study Completion Date :
Apr 1, 2010

Arms and Interventions

Arm Intervention/Treatment
No Intervention: A

exercise referral to lifestyle activities at the level of moderate intensity without support
Active Comparator: B

Exercise referral combined with individual support, access to structured group exercise programs, and motivational support

Behavioral: Support for Increased Physical Activity
Exercise referral combined with individual support, access to structured group exercise programs, and motivational support
Other Names:
  • STAM
  • Stöd Till Aktivare Motion

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The relative effectiveness of two physical activity programs in affecting glucose metabolism, lipid metabolism and stress-related hormone production [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 64 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Center for Family and Community Medicine Huddinge Stockholm Sweden 14183

    Sponsors and Collaborators

    • Karolinska Institutet
    • Region Stockholm

    Investigators

    • Study Director: Jan Sundquist, MD, PhD, Karolinska Institutet

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Kristina Sundqvist, Professor, Karolinska Institutet
    ClinicalTrials.gov Identifier:
    NCT00747942
    Other Study ID Numbers:
    • S-1165
    First Posted:
    Sep 8, 2008
    Last Update Posted:
    Dec 8, 2020
    Last Verified:
    Dec 1, 2020
    Keywords provided by Kristina Sundqvist, Professor, Karolinska Institutet
    overweight
    physical inactivity
    physical fitness
    lifestyle change
    Additional relevant MeSH terms:
    Overweight

    Study Results

    No Results Posted as of Dec 8, 2020