OverweightSTAMNCT00747942
Support for Increased Physical Activity (Stöd Till Aktivare Motion)
A study testing Support for Increased Physical Activity in people with Overweight, run by Karolinska Institutet at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 64 years, women only
- Conditions the study is for
- Overweight
- What is being tested?
- Support for Increased Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2006to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female gender
- Age 25 through 64 years
- Physical inactivity
- BMI > 25
- Immigrant to Sweden from either the Middle East or Latin America
Who cannot join
- Diabetes mellitus type I
- Ischemic heart disease
- Disability that interferes with the ability to participate in lifestyle-related physical activity
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Center for Family and Community Medicine
Huddinge, Stockholm County, 14183
About this study
Official title: Intervention Program for Physically Inactive and Overweight Immigrant Women From the Middle East and Latin America Living in Sweden
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.
- Conditions
- Overweight
- Being tested
- Support for Increased Physical Activity
- Keywords
- overweight, physical inactivity, physical fitness, lifestyle change
- Medical subject headings
- Overweight, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Support for Increased Physical ActivityBehavioural
Also called STAM, Stöd Till Aktivare Motion
Exercise referral combined with individual support, access to structured group exercise programs, and motivational support
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Support for Increased Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relative effectiveness of two physical activity programs in affecting glucose metabolism, lipid metabolism and stress-related hormone production
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2008 (estimated)
- Study startOct 2006
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Kristina Sundqvist, Karolinska Institutet
- Investigators
- Jan Sundquist, MD, PhD, Study director, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00747942
- Sponsor's protocol ID
- S-1165
- Acronym
- STAM
- Status last verified
- Dec 2020
- First submitted
- 4 Sep 2008
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20678219
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Program for Physically Inactive and Overweight Immigrant Women From the Middle East and Latin America Living in Sweden
- ClinicalTrials.gov ID
- NCT00747942
- Acronym / sponsor ID
- STAM / S-1165
- Conditions
- Overweight
- Keywords
- overweight, physical inactivity, physical fitness, lifestyle change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- Oct 2006
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 8 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | No intervention | –exercise referral to lifestyle activities at the level of moderate intensity without support |
| B | Active comparator | Behavioral: Support for Increased Physical ActivityExercise referral combined with individual support, access to structured group exercise programs, and motivational support |
Who may qualify
- Ages
- 25 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female gender
- Age 25 through 64 years
- Physical inactivity
- BMI > 25
- Immigrant to Sweden from either the Middle East or Latin America
Key exclusion criteria (3 listed)
- Diabetes mellitus type I
- Ischemic heart disease
- Disability that interferes with the ability to participate in lifestyle-related physical activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Support for Increased Physical ActivityAlso: STAM, Stöd Till Aktivare MotionExercise referral combined with individual support, access to structured group exercise programs, and motivational support | Behavioural | B |
Primary outcome
The relative effectiveness of two physical activity programs in affecting glucose metabolism, lipid metabolism and stress-related hormone production
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
- Derived from this study: PubMed 20678219Sundquist 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.
- Web page of sponsoring organizationLink provided by the sponsor.
Related trials for Overweight
Active, not recruitingPhase 2
Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment
Electric Stimulation Therapy, Obesity
Active, not recruiting
Adipocyte-Derived Extracellular Vesicles, Weight Loss, and Endothelial Function
Obesity, Weight Loss
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
Not yet recruitingPhase 2
A Study to Evaluate Efficacy and Safety of BGM1812 Injection in Overweight or Obese Participants Without Diabetes
Overweight or Obese Participants Without Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Sundquist, MD, PhD study director
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Support for Increased Physical Activity in people with Overweight, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relative effectiveness of two physical activity programs in affecting glucose metabolism, lipid metabolism and stress-related hormone production (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00747942, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2020.