Overview

This trial is active, not recruiting.

Conditions obesity, physical activity, diabetes
Treatments high intensity arm (intervention), low intensity arm (comparison)
Sponsor University of Utah
Collaborator Department of Health and Human Services
Start date May 2012
End date May 2017
Trial size 400 participants
Trial identifier NCT02470156, 55195

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Arm
(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.
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.
(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).
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.

Primary Outcomes

Measure
Wellness Coaching Program Effectiveness on Goal Success
time frame: 12 months

Secondary Outcomes

Measure
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

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Coalition for a Healthier Community—Utah Women and Girls - Phase II
Principal investigator Kathleen Digre, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of Utah.