Sedentary LifestyleNCT02254902
Physical Activity and Education Program for Somali Women
A study testing Physical Activity intervention in people with Sedentary Lifestyle, run by University of California, San Diego at 1 site in United States.
Trial summary
There is a significant need for culturally adapted and effective health education programs to address rising rates of obesity and chronic disease concerns for refugee communities. Physical activity has been identified as an important prevention tool to prevent numerous chronic health conditions. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- Physical Activity intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Dec 2015
- 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sedentary (less than 90 minutes per week of moderate or vigorous physical activity)
- Self-identify as Somali
- Planning on living in the area for the next 6 months
- Ability to attend 12-weeks of in-person group sessions at a designated community site
Who cannot join
- Currently pregnant or within 3 months of delivery
- BMI greater than or equal to 40
- Medical conditions or physical problems that interfere with physical activity or require medical supervision to exercise
- Have another member of the household participating in the study
- Employment by one of the collaborating organizations
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
La Jolla, California, 92093-0725
About this study
Official title: Physical Activity and Education to Reduce Cancer Risk Among Somali Women (Ladnaan Project)
There is a significant need for culturally adapted and effective health education programs to address rising rates of obesity and chronic disease concerns for refugee communities. Physical activity has been identified as an important prevention tool to prevent numerous chronic health conditions. This research tests the feasibility and acceptability of a culturally adapted physical activity intervention for sedentary adult Somali women. Study participants will be randomized to a 3-month physical activity program or a wait-list control group. The primary outcome is increases in physical activity between baseline and the end of the program as measured by pedometer.
Read the detailed description
Participants in the physical activity program will participate in 12 weekly 1.5-hour sessions focused on increasing physical activity. The group sessions will include participating in physical activity as well as group discussions on the barriers and opportunities for increasing physical activity in their daily life. The 12-week program covers educational topics related to physical activity (e.g. overcoming barriers to activity, exercising safely, relapse prevention strategies) and the program gradually increases the amount of physical activity completed during the group sessions over the course of the 12 weeks. Over a 3-month wait period, individuals in the wait-list control group will be offered monthly sessions on health and wellness topics before being offered the physical activity program. Measurement visits will occur at baseline, at the end of the12-week program, and approximately 12-weeks after the end of the intervention. During the measurement sessions participants will complete assessments related to their physical activity and other health behaviors.
- Conditions
- Sedentary Lifestyle
- Being tested
- Physical Activity intervention
- Keywords
- sedentary lifestyle, physical activity, Somali women, prevention
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity interventionBehavioural
The Physical Activity intervention is a 3-month group-based program based on an efficacious physical activity intervention that has been culturally adapted for use with adult Somali women. The program targets increased physical activity through educational and experiential opportunities.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity | Experimental | Participants in the Physical Activity intervention arm of the study receive culturally-modified, materials through participation in 12 weekly 1-.5-hour sessions focused on increasing daily step counts and bouts of moderate intensity physical activity. The group sessions include participation in different forms of physical activity as well as group discussions on the barriers and opportunities for increasing physical activity in daily life. Receives: Behavioral: Physical Activity intervention |
| Wait List Control | No intervention | Participants in the Wait List Control will be offered the program after a 3-month wait period. While waiting for the program, participants are offered to attend monthly sessions on various wellness and prevention topics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical activity as measured by pedometer from baseline to 3 months
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Changes in funding status
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Principal investigator, Kate Murray, PhD, MPH, University of California, San Diego
- Investigators
- Kate E Murray, PhD, MPH, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02254902
- Sponsor's protocol ID
- ACS-MRSG-13-069
- Status last verified
- May 2016
- First submitted
- 29 Sep 2014
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and Education to Reduce Cancer Risk Among Somali Women (Ladnaan Project)
- ClinicalTrials.gov ID
- NCT02254902
- Acronym / sponsor ID
- ACS-MRSG-13-069
- Conditions
- Sedentary Lifestyle
- Keywords
- sedentary lifestyle, physical activity, Somali women, prevention
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Changes in funding status
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 2 Oct 2014 (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.
There is a significant need for culturally adapted and effective health education programs to address rising rates of obesity and chronic disease concerns for refugee communities. Physical activity has been identified as an important prevention tool to prevent numerous chronic health conditions. This research tests the feasibility and acceptability of a culturally adapted physical activity intervention for sedentary adult Somali women. Study participants will be randomized to a 3-month physical activity program or a wait-list control group. The primary outcome is increases in physical activity between baseline and the end of the program as measured by pedometer.
Detailed description
Participants in the physical activity program will participate in 12 weekly 1.5-hour sessions focused on increasing physical activity. The group sessions will include participating in physical activity as well as group discussions on the barriers and opportunities for increasing physical activity in their daily life. The 12-week program covers educational topics related to physical activity (e.g. overcoming barriers to activity, exercising safely, relapse prevention strategies) and the program gradually increases the amount of physical activity completed during the group sessions over the course of the 12 weeks. Over a 3-month wait period, individuals in the wait-list control group will be offered monthly sessions on health and wellness topics before being offered the physical activity program. Measurement visits will occur at baseline, at the end of the12-week program, and approximately 12-weeks after the end of the intervention. During the measurement sessions participants will complete assessments related to their physical activity and other health behaviors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity | Experimental | Behavioral: Physical Activity interventionParticipants in the Physical Activity intervention arm of the study receive culturally-modified, materials through participation in 12 weekly 1-.5-hour sessions focused on increasing daily step counts and bouts of moderate intensity physical activity. The group sessions include participation in different forms of physical activity as well as group discussions on the barriers and opportunities for increasing physical activity in daily life. |
| Wait List Control | No intervention | –Participants in the Wait List Control will be offered the program after a 3-month wait period. While waiting for the program, participants are offered to attend monthly sessions on various wellness and prevention topics. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Sedentary (less than 90 minutes per week of moderate or vigorous physical activity)
- Self-identify as Somali
- Planning on living in the area for the next 6 months
- Ability to attend 12-weeks of in-person group sessions at a designated community site
Key exclusion criteria (5 listed)
- Currently pregnant or within 3 months of delivery
- BMI greater than or equal to 40
- Medical conditions or physical problems that interfere with physical activity or require medical supervision to exercise
- Have another member of the household participating in the study
- Employment by one of the collaborating organizations
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 |
|---|---|---|
| Physical Activity interventionThe Physical Activity intervention is a 3-month group-based program based on an efficacious physical activity intervention that has been culturally adapted for use with adult Somali women. The program targets increased physical activity through educational and experiential opportunities. | Behavioural | Physical Activity |
Primary outcome
Change in physical activity as measured by pedometer from baseline to 3 months
Time frame: Baseline and 3 months
Results and safety
The study was stopped early (reason given: Changes in funding status). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
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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.
Kate E Murray, PhD, MPH principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity intervention in people with Sedentary Lifestyle, run by University of California, San Diego at 1 site in United States.
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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 13 May 2016. 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 United States. 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 was stopped early (reason given: Changes in funding status). Results are not available in the source record.
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?
Change in physical activity as measured by pedometer from baseline to 3 months (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2016.