Obesity Clinical Trial
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.
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.
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