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Completed

NCT Number: NCT02470156

Coalition for a Healthier Community-Utah Women and Girls - Phase II (UWAG-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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah

Salt Lake City, Utah, 84132, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Intensity Arm (Intervention)

Behavioral

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)

Behavioral

The low intensity intervention involves wellness coaching, personalized goal setting, and progress tracking at baseline, 4 months, 8 months, and 12 months.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Change in weight

    Time frame: Baseline and 12 Months

  4. Change in Body Mass Index (BMI)

    Time frame: Baseline and 12 Months

  5. Change in waist circumference

    Time frame: Baseline and 12 Months

  6. Change in waist to hip ratio

    Time frame: Baseline and 12 Months

  7. 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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • Department of Health and Human Services

Registry information

Official study title

Coalition for a Healthier Community-Utah Women and Girls - Phase II

Acronym: UWAG-II

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Jun 12, 2015
Registry last updated
Oct 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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