Support for Increased Physical Activity (Stöd Till Aktivare Motion) - Full Text View

Sponsors and Collaborators:	Karolinska Institutet Stockholm County Council
Information provided by:	Karolinska Institutet
ClinicalTrials.gov Identifier:	NCT00747942

Purpose

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	Intervention
Overweight	Behavioral: Support for Increased Physical Activity

MedlinePlus related topics: Exercise and Physical Fitness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Intervention Program for Physically Inactive and Overweight Immigrant Women From the Middle East and Latin America Living in Sweden

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:

The relative effectiveness of two physical activity programs in affecting glucose metabolism, lipid metabolism and stress-related hormone production [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment:	234
Study Start Date:	October 2006
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: No Intervention exercise referral to lifestyle activities at the level of moderate intensity without support
B: Active Comparator 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

Eligibility

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00747942

Locations

Sweden, Stockholm
Center for Family and Community Medicine
Huddinge, Stockholm, Sweden, 14183

Sponsors and Collaborators

Karolinska Institutet

Stockholm County Council

Investigators

Study Director:

Jan Sundquist, MD, PhD

Karolinska Institutet

More Information

Web page of sponsoring organization This link exits the ClinicalTrials.gov site

Responsible Party:	Karolinska Institutet, Center for Family and Community Medicine ( Kristina Sundquist, professor )
Study ID Numbers:	S-1165
Study First Received:	September 4, 2008
Last Updated:	September 5, 2008
ClinicalTrials.gov Identifier:	NCT00747942
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by Karolinska Institutet:

overweight
physical inactivity
physical fitness
lifestyle change

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Overweight

ClinicalTrials.gov processed this record on January 14, 2009