ObesityUWAG-IINCT02470156
Coalition for a Healthier Community-Utah Women and Girls - Phase II (UWAG-II)
A study testing High Intensity Arm (Intervention) and Low Intensity Arm (Comparison) in people with Obesity and Physical Activity, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Physical Activity, Diabetes
- What is being tested?
- High Intensity Arm (Intervention) and Low Intensity Arm (Comparison)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 556 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Oct 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Coalition for a Healthier Community-Utah Women and Girls - Phase II
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.
Read the 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.
- Conditions
- Obesity, Physical Activity, Diabetes
- Being tested
- High Intensity Arm (Intervention), Low Intensity Arm (Comparison)
- Keywords
- community based participatory research, healthy eating, physical activity, obesity
- Medical subject headings
- Obesity, Motor Activity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Arm (Intervention)Behavioural
The high intensity intervention involves monthly wellness coaching, personalized goal setting, and progress tracking in addition to monthly group activities and social support.
Low Intensity Arm (Comparison)Behavioural
The low intensity intervention involves wellness coaching, personalized goal setting, and progress tracking at baseline, 4 months, 8 months, and 12 months.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Arm (Intervention) | Experimental | 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. Receives: Behavioral: High Intensity Arm (Intervention) |
| Low Intensity Arm (Comparison) | Active comparator | 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). Receives: Behavioral: Low Intensity Arm (Comparison) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (7)
Health Behaviors of Partners
Participants will report on changes in the diet and exercise changes of their partners during the 12 month study.
Measured: 12 Months
Health Behaviors of Children
Participants will report on changes in the diet and exercise changes of their children during the 12 month study.
Measured: 12 Months
Change in weight
Measured: Baseline and 12 Months
Change in Body Mass Index (BMI)
Measured: Baseline and 12 Months
Change in waist circumference
Measured: Baseline and 12 Months
Change in waist to hip ratio
Measured: Baseline and 12 Months
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.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study startMay 2012
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 556 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services
- Responsible party
- Principal investigator, Kathleen Digre, University of Utah
- Investigators
- Kathleen Digre, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02470156
- Sponsor's protocol ID
- 55195
- Acronym
- UWAG-II
- Status last verified
- Oct 2018
- First submitted
- 3 Jun 2015
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 33022316Buder 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.
PubMed 30309276
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coalition for a Healthier Community-Utah Women and Girls - Phase II
- ClinicalTrials.gov ID
- NCT02470156
- Acronym / sponsor ID
- UWAG-II / 55195
- Conditions
- Obesity, Physical Activity, Diabetes
- Keywords
- community based participatory research, healthy eating, physical activity, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 556 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Department of Health and Human Services
- Study start
- May 2012 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 12 Jun 2015 (estimated)
- 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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Intensity Arm (Intervention) | Experimental | Behavioral: 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. |
| Low Intensity Arm (Comparison) | Active comparator | Behavioral: 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| High Intensity Arm (Intervention)The high intensity intervention involves monthly wellness coaching, personalized goal setting, and progress tracking in addition to monthly group activities and social support. | Behavioural | High Intensity Arm (Intervention) |
| Low Intensity Arm (Comparison)The low intensity intervention involves wellness coaching, personalized goal setting, and progress tracking at baseline, 4 months, 8 months, and 12 months. | Behavioural | Low Intensity Arm (Comparison) |
Primary outcome
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.
7 secondary outcomes
Health Behaviors of Partners
Time frame: 12 Months
Health Behaviors of Children
Time frame: 12 Months
Change in weight
Time frame: Baseline and 12 Months
Change in Body Mass Index (BMI)
Time frame: Baseline and 12 Months
Change in waist circumference
Time frame: Baseline and 12 Months
Change in waist to hip ratio
Time frame: Baseline and 12 Months
Economic Assessment of the Intervention
Time frame: 12 Months
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 Oct 2018.
- Derived from this study: PubMed 33022316Buder 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.
- Derived from this study: PubMed 30309276Buder 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.
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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.
Kathleen Digre, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Arm (Intervention) and Low Intensity Arm (Comparison) in people with Obesity and Physical Activity, run by University of Utah 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 9 inclusion and 6 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 Oct 2018. 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?
Wellness Coaching Program Effectiveness on Goal Success (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02470156, which also lists 2 linked publications.
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 Oct 2018.