Physical ActivityNCT03681756
WALK Study: Women's Active Living for Koreans Study
A study testing WALK in people with Physical Activity and Metabolic Syndrome, run by University of California, San Francisco at 1 site in United States.
Trial summary
The prevalence of metabolic syndrome (MetS) is a health concern among Asians. Growing evidence indicates that Korean Americans had higher MetS prevalence compared to non-Hispanic Whites, but a culturally and linguistically appropriate lifestyle intervention has not been developed for Korean American middle-aged and… Read more about this study
- Who is it for?
- Ages 40 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Metabolic Syndrome, Lifestyle, Sedentary
- What is being tested?
- WALK
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2018to 31 Dec 2018
- 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 40 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-identified Korean-speaking Korean American women
- Sedentary lifestyle at work and/or during leisure time
- Aged between 40 and 69; 4) intention to be physically active
- KakaoTalk user
Who cannot join
- Medical conditions or physical problems requiring a special care exercise program
- Known bone or join problems that impair the ability to do moderate physical activity
- Participating in a lifestyle modification program or research study
- Planning a trip out of the U.S. during the next 2 months
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94118
About this study
Official title: Development of a Lifestyle Intervention for Korean American Women at Risk for Metabolic Syndrome
The prevalence of metabolic syndrome (MetS) is a health concern among Asians. Growing evidence indicates that Korean Americans had higher MetS prevalence compared to non-Hispanic Whites, but a culturally and linguistically appropriate lifestyle intervention has not been developed for Korean American middle-aged and older women. Thus, the investigators propose to develop a 4-week lifestyle intervention (Women's Active Living for Koreans (WALK) Study) to increase physical activity (PA) and reduce sedentary behavior for Korean American women.
Read the detailed description
The purpose of this pilot study is to develop a 4-week lifestyle intervention (Women's Active Living for Koreans (WALK) Study) to increase physical activity (PA) and reduce sedentary behavior for Korean American women. The investigators will assess feasibility and acceptability of the WALK Study and potential efficacy of the WALK Study on outcomes including sedentary behavior and PA.
- Conditions
- Physical Activity, Metabolic Syndrome, Lifestyle, Sedentary
- Being tested
- WALK
- Medical subject headings
- Motor Activity, Metabolic Syndrome, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WALKBehavioural
Walking program
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | No intervention | Participants will receive an in-person session and an activity monitor |
| Group 2 | Experimental | Participants will receive an in-person session, an activity monitor, and social support through BAND Receives: Behavioral: WALK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
Time spent in moderate and vigorous activity
Measured: Last 7 days
Secondary outcomes (1)
Sedentary behavior
Time spent in sedentary activity
Measured: Last 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start31 Aug 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ji Won Choi, RN, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03681756
- Sponsor's protocol ID
- 18-24293
- Status last verified
- Apr 2019
- First submitted
- 19 Sep 2018
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Lifestyle Intervention for Korean American Women at Risk for Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT03681756
- Acronym / sponsor ID
- 18-24293
- Conditions
- Physical Activity, Metabolic Syndrome, Lifestyle, Sedentary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 31 Aug 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 24 Sep 2018 (actual)
- 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 prevalence of metabolic syndrome (MetS) is a health concern among Asians. Growing evidence indicates that Korean Americans had higher MetS prevalence compared to non-Hispanic Whites, but a culturally and linguistically appropriate lifestyle intervention has not been developed for Korean American middle-aged and older women. Thus, the investigators propose to develop a 4-week lifestyle intervention (Women's Active Living for Koreans (WALK) Study) to increase physical activity (PA) and reduce sedentary behavior for Korean American women.
Detailed description
The purpose of this pilot study is to develop a 4-week lifestyle intervention (Women's Active Living for Koreans (WALK) Study) to increase physical activity (PA) and reduce sedentary behavior for Korean American women. The investigators will assess feasibility and acceptability of the WALK Study and potential efficacy of the WALK Study on outcomes including sedentary behavior and PA.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | No intervention | –Participants will receive an in-person session and an activity monitor |
| Group 2 | Experimental | Behavioral: WALKParticipants will receive an in-person session, an activity monitor, and social support through BAND |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Self-identified Korean-speaking Korean American women
- Sedentary lifestyle at work and/or during leisure time
- Aged between 40 and 69; 4) intention to be physically active
- KakaoTalk user
Key exclusion criteria (5 listed)
- Medical conditions or physical problems requiring a special care exercise program
- Known bone or join problems that impair the ability to do moderate physical activity
- Participating in a lifestyle modification program or research study
- Planning a trip out of the U.S. during the next 2 months
- Pregnancy.
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 |
|---|---|---|
| WALKWalking program | Behavioural | Group 2 |
Primary outcome
Physical activity
Time frame: Last 7 days
Time spent in moderate and vigorous activity
1 secondary outcome
Sedentary behavior
Time frame: Last 7 days
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 12 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Ji Won Choi, RN, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WALK in people with Physical Activity and Metabolic Syndrome, run by University of California, San Francisco 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: finished, as of the sponsor's last update on 12 Apr 2019. 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 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?
Physical activity (time frame: Last 7 days). 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 12 Apr 2019.