Obesity Clinical Trial
— UWAG-IIOfficial title:
Coalition for a Healthier Community—Utah Women and Girls - Phase II
NCT number | NCT02470156 |
Other study ID # | 55195 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2012 |
Est. completion date | October 2018 |
Verified date | October 2018 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This 12-month randomized trial is designed to evaluate the impact of low intensity (quarterly) versus high intensity (monthly) wellness coaching programs on women's success achieving individual health goals related to active living and healthy eating and changes in these health behaviors over time.
Status | Completed |
Enrollment | 556 |
Est. completion date | October 2018 |
Est. primary completion date | October 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Self-identifies as a female - Self-identifies as a member of one of the 5 target communities: African American, African, American Indian/Alaskan Native, Hispanic/Latina, Pacific Islander - Subject is age 18 or older - Not currently participating in the WISEWOMAN Program or another Wellness Coach Program - Fluent in English, Spanish, or Kirundi - Willing to be randomized to high versus low intensity wellness coaching program - Willing to set a goal related to diet or physical activity - Willing to be followed for 12 months - Willing to complete interviews and health data collection at baseline, 4, 8, and 12 months Exclusion Criteria: - Subject is less than 18 years of age - Subject is currently participating in a wellness coach program - Not fluent in English, Spanish, or Kirundi - Unwilling to be randomized - Unwilling to be followed for 12 months - Unwilling to participate in interviews and data collection |
Country | Name | City | State |
---|---|---|---|
United States | University of Utah | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Utah | Department of Health and Human Services |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Wellness Coaching Program Effectiveness on Goal Success | The primary outcome is a composite consisting of either an increase in the number of fruits and vegetables consumed in an average week and/ or in the number of minutes spent doing moderate or vigorous physical activity in an average week, depending on the participant's target goal, at 12 months after enrolling in the study. | 12 months | |
Secondary | Health Behaviors of Partners | Participants will report on changes in the diet and exercise changes of their partners during the 12 month study. | 12 Months | |
Secondary | Health Behaviors of Children | Participants will report on changes in the diet and exercise changes of their children during the 12 month study. | 12 Months | |
Secondary | Change in weight | Baseline and 12 Months | ||
Secondary | Change in Body Mass Index (BMI) | Baseline and 12 Months | ||
Secondary | Change in waist circumference | Baseline and 12 Months | ||
Secondary | Change in waist to hip ratio | Baseline and 12 Months | ||
Secondary | Economic Assessment of the Intervention | The cost-effectiveness ratio (CER), which assesses the cost per quality-adjusted life year (QALY), will be generated. Gains in QALYs from increased physical activity will be calculated and quantified for women who went from physically inactive to physically active, and from physically inactive to insufficiently active. QALYs will be calculated using weights which represented societal values of health states, and adjusted demographic factors, BMI, medical conditions, and health status. | 12 Months |
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