Coalition for a Healthier Community-Utah Women and Girls - Phase II (UWAG-II)
UWAG-II
1 other identifier
interventional
556
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started May 2012
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 3, 2015
CompletedFirst Posted
Study publicly available on registry
June 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedOctober 12, 2018
October 1, 2018
6.4 years
June 3, 2015
October 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Health Behaviors of Partners
12 Months
Health Behaviors of Children
12 Months
Change in weight
Baseline and 12 Months
Change in Body Mass Index (BMI)
Baseline and 12 Months
Change in waist circumference
Baseline and 12 Months
- +2 more secondary outcomes
Study Arms (2)
High Intensity Arm (Intervention)
EXPERIMENTALWomen in the High Intensity (intervention) arm are counseled by a wellness coach and have a group meeting each month. They are also interviewed four times (at baseline, 4 months, 8 months, and 12 months). Women in the high intensity group must have monthly contact with coaches during at least 9 of 12 months via participation in a group activity and/or monthly coaching to receive a "full dose" of the intervention.
Low Intensity Arm (Comparison)
ACTIVE COMPARATORWomen in the Low Intensity (comparison) arm are interviewed and coached four times during the study (at baseline, 4 months, 8 months, and 12 months).
Interventions
The high intensity intervention involves monthly wellness coaching, personalized goal setting, and progress tracking in addition to monthly group activities and social support.
The low intensity intervention involves wellness coaching, personalized goal setting, and progress tracking at baseline, 4 months, 8 months, and 12 months.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Utahlead
- Department of Health and Human Servicescollaborator
Study Sites (1)
University of Utah
Salt Lake City, Utah, 84132, United States
Related Publications (2)
Buder I, Waitzman N, Zick C. The medical costs of low leisure-time physical activity among working-age adults: Gender and minority status matter. Prev Med. 2020 Dec;141:106273. doi: 10.1016/j.ypmed.2020.106273. Epub 2020 Oct 4.
PMID: 33022316DERIVEDBuder I, Zick C, Waitzman N, Simonsen S, Sunada G, Digre K. It Takes a Village Coach: Cost-Effectiveness of an Intervention to Improve Diet and Physical Activity Among Minority Women. J Phys Act Health. 2018 Nov 1;15(11):819-826. doi: 10.1123/jpah.2017-0285. Epub 2018 Oct 11.
PMID: 30309276DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathleen Digre, MD
University of Utah
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
June 3, 2015
First Posted
June 12, 2015
Study Start
May 1, 2012
Primary Completion
October 1, 2018
Study Completion
October 1, 2018
Last Updated
October 12, 2018
Record last verified: 2018-10