- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02470156
Coalition for a Healthier Community-Utah Women and Girls - Phase II (UWAG-II) (UWAG-II)
Coalition for a Healthier Community-Utah Women and Girls - Phase II
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In Utah, rates of obesity are elevated among non-White and Hispanic women (Utah BRFSS Data, 2008-2012). In order to address these disparities, the Coalition for a Healthier Community for Utah Women and Girls (UWAG) was formed to test the effectiveness of interventions for improving health behaviors delivered through community wellness coaches. UWAG is a strong partnership between academic and public health professionals and Community Faces of Utah (CFU), a coalition representing five underserved communities (African, African American, American Indian, Hispanic and, Pacific Islander).
The investigators hypothesize that a wellness coaching program using an evidence-based lifestyle intervention that has been tailored to meet the gender and cultural needs of women from five diverse, often underserved communities, will be significantly more effective in promoting and sustaining behavioral changes than a less intensive wellness coach program. The primary outcome consists 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. The investigators view these as proxy measures for obesity prevention and reduction, and are also collecting data to track changes in weight, BMI and waist-to hip ratio throughout the study.
Wellness coaches are lay community members recruited from each of the CFU communities. They received extensive training and support from the UWAG team. After informed consent and completion of baseline study activities, study participants are randomized into intervention (high intensity) and comparison (low intensity) groups. Participants in both groups receive the evidenced-based program, A New Leaf, tailored to address socio-cultural and gender issues and delivered through community wellness coaches from their own communities. Participants in the high-intensity intervention group participate in monthly group activities in addition to monthly wellness coaching sessions. Participants in the low-intensity comparison group participate in health coaching every 4 months. All participants establish their own goals for fruit and vegetable consumption, physical activity, or both. Investigators collect survey and clinical data at baseline, 4, 8, and 12 months after enrolling and once a year after participants complete the intervention. A return on investment analysis will be conducted. The investigators hypothesize that the more intensive program will lead to better outcomes, and they will assess whether the difference in degree of outcomes warrants its additional costs and resources. Survey data are being collected and include information about demographics, health behaviors, goals and progress towards achieving goals, mental health, self-efficacy, and socio-cultural/gender roles/behaviors related to obesity. Clinical data (blood pressure, body mass index, and waist-to hip ratio) are also collected.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84132
- University of Utah
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High Intensity Arm (Intervention)
Women 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.
|
The high intensity intervention involves monthly wellness coaching, personalized goal setting, and progress tracking in addition to monthly group activities and social support.
|
Active Comparator: Low Intensity Arm (Comparison)
Women in the Low Intensity (comparison) arm are interviewed and coached four times during the study (at baseline, 4 months, 8 months, and 12 months).
|
The low intensity intervention involves wellness coaching, personalized goal setting, and progress tracking at baseline, 4 months, 8 months, and 12 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wellness Coaching Program Effectiveness on Goal Success
Time Frame: 12 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health Behaviors of Partners
Time Frame: 12 Months
|
Participants will report on changes in the diet and exercise changes of their partners during the 12 month study.
|
12 Months
|
Health Behaviors of Children
Time Frame: 12 Months
|
Participants will report on changes in the diet and exercise changes of their children during the 12 month study.
|
12 Months
|
Change in weight
Time Frame: Baseline and 12 Months
|
Baseline and 12 Months
|
|
Change in Body Mass Index (BMI)
Time Frame: Baseline and 12 Months
|
Baseline and 12 Months
|
|
Change in waist circumference
Time Frame: Baseline and 12 Months
|
Baseline and 12 Months
|
|
Change in waist to hip ratio
Time Frame: Baseline and 12 Months
|
Baseline and 12 Months
|
|
Economic Assessment of the Intervention
Time Frame: 12 Months
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kathleen Digre, MD, University of Utah
Publications and helpful links
General Publications
- 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.
- Buder 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 55195
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on High Intensity Arm (Intervention)
-
VA Office of Research and DevelopmentCompleted
-
Nottingham University Hospitals NHS TrustNational Institute for Health Research, United KingdomCompletedDementia MCI (Mild Cognitive Impairment)
-
Haute Ecole de Santé VaudUnknownPhysical Activity | Rehabilitation | Thoracic Surgery
-
NYU Langone HealthCompletedGeneralized Anxiety Disorder | Social Anxiety | Panic DisorderUnited States
-
University of TorontoUnknownPostpartum WomenCanada
-
Centre for Addiction and Mental HealthThe Hospital for Sick Children; University of Toronto; Trillium Health Centre; Medical...CompletedPsychosis | Cardiovascular Risk Factor | Metabolic DiseaseCanada
-
VA Office of Research and DevelopmentRecruitingSpinal Cord InjuryUnited States
-
Copenhagen University Hospital at HerlevRecruitingProstate CancerDenmark
-
VA Office of Research and DevelopmentCompletedStroke | Cerebrovascular AccidentUnited States
-
Syracuse UniversityRecruitingCardiovascular Diseases | Obesity | Metabolic Disease | High-intensity Interval TrainingUnited States