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

Primary Purpose

Overweight

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Support for Increased Physical Activity

About this trial

This is an interventional prevention trial for Overweight focused on measuring overweight, physical inactivity, physical fitness, lifestyle change

Eligibility Criteria

25 Years - 64 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Center for Family and Community Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Arm Description

exercise referral to lifestyle activities at the level of moderate intensity without support

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

Outcomes

Primary Outcome Measures

The relative effectiveness of two physical activity programs in affecting glucose metabolism, lipid metabolism and stress-related hormone production

Secondary Outcome Measures

Full Information

NCT ID

NCT00747942

First Posted

September 4, 2008

Last Updated

December 7, 2020

Sponsor

Karolinska Institutet

Collaborators

Region Stockholm

1. Study Identification

Unique Protocol Identification Number

NCT00747942

Brief Title

Support for Increased Physical Activity (Stöd Till Aktivare Motion)

Acronym

STAM

Official Title

Intervention Program for Physically Inactive and Overweight Immigrant Women From the Middle East and Latin America Living in Sweden

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

October 2006 (undefined)

Primary Completion Date

April 2010 (Actual)

Study Completion Date

April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Karolinska Institutet

Collaborators

Region Stockholm

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight

Keywords

overweight, physical inactivity, physical fitness, lifestyle change

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

234 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

No Intervention

Arm Description

exercise referral to lifestyle activities at the level of moderate intensity without support

Arm Title

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Support for Increased Physical Activity

Other Intervention Name(s)

STAM, Stöd Till Aktivare Motion

Intervention Description

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

Primary Outcome Measure Information:

Title

The relative effectiveness of two physical activity programs in affecting glucose metabolism, lipid metabolism and stress-related hormone production

Time Frame

2 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jan Sundquist, MD, PhD

Organizational Affiliation

Karolinska Institutet

Official's Role

Study Director

Facility Information:

Facility Name

Center for Family and Community Medicine

City

Huddinge

State/Province

Stockholm

ZIP/Postal Code

14183

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

20678219

Citation

Sundquist J, Hagstromer M, Johansson SE, Sundquist K. Effect of a primary health-care-based controlled trial for cardiorespiratory fitness in refugee women. BMC Fam Pract. 2010 Aug 2;11:55. doi: 10.1186/1471-2296-11-55.

Results Reference

derived

Links:

URL

http://www.cefam.se

Description

Web page of sponsoring organization

Learn more about this trial

Support for Increased Physical Activity (Stöd Till Aktivare Motion)

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