Health Without Barriers/Salud Sin Barreras- Northern Colorado (HWB/SSB)
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Details and patient eligibility
About
The overarching goal of this work is to address the limited access to evidence-based health behavior and lifestyle interventions for youth and families most impacted by preventable chronic diseases, including obesity and type 2 diabetes. In the current project, we implement a small single-arm pilot and feasibility trial of Health Without Barriers/Salud Sin Barreras (HWB/SSB), a culturally-adapted, whole-family intensive health behavior and lifestyle intervention to 11-19-year-old adolescents and their families living in Northern Colorado. Objectives are refining the HWB/SSB community facilitator training, evaluating the feasibility and acceptability of HWB/SSB implementation, and characterizing changes in health outcomes among adolescent participants.
Full description
Health Without Barriers/Salud Sin Barreras (HWB/SSB) is a 12-session community-delivered, whole-family intensive health behavior and lifestyle intervention for health promotion and reduction of risk for chronic diseases (e.g., type 2 diabetes). The program is delivered over 6 weeks and includes mindfulness-based stress reduction training for adolescents, parent/caregiver health education and mindfulness training, youth physical activity, and whole-family nutrition education and cooking/meal preparation. Previous and ongoing work has focused on gathering and using direct input from local community members and families from Southwest Colorado to adapt HWB/SSB to ensure cultural suitability for teenagers and their families in this region. Now, there is a need for further refinement of HWB/SSB community facilitator training and evaluation of the intervention. The HWB/SSB intervention delivery is NOT considered human subjects research; only the evaluation, dissemination, and implementation elements are considered research (objectives described below). The intervention will be delivered regardless of any research study, and participation in the research study is not a requirement for families to enroll in HWB/SSB or for facilitators to facilitate the intervention.
There are three main objectives to this study:
- Train community-based facilitators for HWB/SSB and refine training through: (a) conducting a series of focus groups with facilitators (up to n=20), (b) facilitator completion of a knowledge tests before and after training, (c) facilitator completion of surveys to evaluate and refine training processes, and (d) monitoring fidelity of HWB delivery through completion of standardized checklists by HWB trainers of mock and live sessions and through facilitator fidelity surveys.
- Enroll adolescents (up to n=60) and parents/caregivers (up to n=60) from Northern Colorado in HWB/SSB to evaluate the acceptability and feasibility of the program. Program acceptability will be assessed through a series of focus groups and acceptability surveys completed by the participants. Program attendance and retention will be used to assess feasibility.
- Describe changes in adolescents' psychological, health behavior, and health-related outcomes from before to up to 1-year after HWB/SSB participation. Outcomes include: 1) cardiometabolic health, 2) stress management, 3) enjoyment, self-efficacy, and frequency of physical activity, 4) healthy eating behaviors, and 5) sleep health.
Enrollment
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Volunteers
Inclusion and exclusion criteria
Inclusion Criteria:
Adolescent subjects
- Between the ages 11-19 years old
- Reside in Larimer County, Weld County, or the surrounding areas.
Parent/guardian subjects:
- 18 years old or older
- Are parents/guardians of an adolescent between the ages of 11-19
- Reside in Larimer County, Weld County, or the surrounding areas
Facilitators subjects
- 18 years old or older
- Reside in Larimer County, Weld County, or the surrounding areas
- Are planning to or have facilitated HWB
Exclusion Criteria
Adolescents subjects will not take part in the research activities if they have a medical and/or psychological/behavioral condition that, in the opinion of the Colorado State University/Extension program team, could interfere with safety for themselves or others or interfere with the capability of the participant or other participants to potentially benefit from the program (e.g., severe emotional-behavioral disturbance, inability to follow facilitator directions).
Parents/guardians will not take part in the research activities if they have a medical and/or psychological/behavioral condition that, in the opinion of the Colorado State University/Extension program team, could interfere with safety for themselves or others or interfere with the capability of their family or other participating families to potentially benefit from the program (e.g., using drugs or alcohol or under the use of drugs/alcohol during program sessions, aggressive or inappropriate behavior toward other participants).
There is no exclusion for facilitator subjects.
Trial design
Primary purpose
Allocation
Interventional model
Masking
140 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Lauren B Shomaker, PhD; Natalia Sanchez, MPH
Data sourced from clinicaltrials.gov
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