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WALK Study: Women's Active Living for Koreans Study

Primary Purpose

Physical Activity, Metabolic Syndrome, Lifestyle, Sedentary

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
WALK
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Physical Activity

Eligibility Criteria

40 Years - 69 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria

  • 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.

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Group 1

Group 2

Arm Description

Participants will receive an in-person session and an activity monitor

Participants will receive an in-person session, an activity monitor, and social support through BAND

Outcomes

Primary Outcome Measures

Physical activity
Time spent in moderate and vigorous activity

Secondary Outcome Measures

Sedentary behavior
Time spent in sedentary activity

Full Information

First Posted
September 19, 2018
Last Updated
April 10, 2019
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT03681756
Brief Title
WALK Study: Women's Active Living for Koreans Study
Official Title
Development of a Lifestyle Intervention for Korean American Women at Risk for Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
August 31, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Activity, Metabolic Syndrome, Lifestyle, Sedentary

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
No Intervention
Arm Description
Participants will receive an in-person session and an activity monitor
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Participants will receive an in-person session, an activity monitor, and social support through BAND
Intervention Type
Behavioral
Intervention Name(s)
WALK
Intervention Description
Walking program
Primary Outcome Measure Information:
Title
Physical activity
Description
Time spent in moderate and vigorous activity
Time Frame
Last 7 days
Secondary Outcome Measure Information:
Title
Sedentary behavior
Description
Time spent in sedentary activity
Time Frame
Last 7 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ji Won Choi, RN, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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WALK Study: Women's Active Living for Koreans Study

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