NCT00747942

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 8, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

December 8, 2020

Status Verified

December 1, 2020

Enrollment Period

3.5 years

First QC Date

September 4, 2008

Last Update Submit

December 7, 2020

Conditions

Keywords

overweightphysical inactivityphysical fitnesslifestyle change

Outcome Measures

Primary Outcomes (1)

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

    2 years

Study Arms (2)

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

Interventions

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

Also known as: STAM, Stöd Till Aktivare Motion
B

Eligibility Criteria

Age25 Years - 64 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female gender
  • Age 25 through 64 years
  • Physical inactivity
  • BMI \> 25
  • Immigrant to Sweden from either the Middle East or Latin America

You may not qualify if:

  • Diabetes mellitus type I
  • Ischemic heart disease
  • Disability that interferes with the ability to participate in lifestyle-related physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Family and Community Medicine

Huddinge, Stockholm County, 14183, Sweden

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

OverweightSedentary Behavior

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Jan Sundquist, MD, PhD

    Karolinska Institutet

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 4, 2008

First Posted

September 8, 2008

Study Start

October 1, 2006

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

December 8, 2020

Record last verified: 2020-12

Locations