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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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)
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.

United States1 site
  • University of Utah

    Salt Lake City, Utah, 84132

Other trials in United States

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.

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 groups in NCT02470156
Study groupRoleWhat they receive
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.
Receives: Behavioral: High Intensity Arm (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).
Receives: Behavioral: Low Intensity Arm (Comparison)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (7)
  1. 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

  2. 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

  3. Change in weight

    Measured: Baseline and 12 Months

  4. Change in Body Mass Index (BMI)

    Measured: Baseline and 12 Months

  5. Change in waist circumference

    Measured: Baseline and 12 Months

  6. Change in waist to hip ratio

    Measured: Baseline and 12 Months

  7. 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.

  1. First posted12 Jun 2015 (estimated)
  2. Study startMay 2012
  3. Primary completionOct 2018
  4. Study completionOct 2018

Resources

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)
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 33022316
  • 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.

    PubMed 30309276

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.

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