Clinical trial NCT06822387: Health Without Barriers/Salud Sin Barreras- Northern Colorado
Official title: Growing an Extension Network for Multisite Dissemination and Implementation of Intensive Health Behavior and Lifestyle Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lifestyle Risk Reduction
Adolescent Health
Family Health
Cardio-metabolic Health
Mental Health
Wellness Program
Type 2 Diabetes
Obesity, Adolescent
Keywords: Whole-family
Mindfulness
Wellness education
Nutrition
Physical Activity
Stress reduction
Health Without Barriers
Salud Sin Barreras
Lead sponsor: Colorado State University
Sponsor class: OTHER
Collaborators: name: Colorado State University Extension-Larimer County
name: Colorado State University Extension-Weld County
name: Colorado State University Extension-La Plata County
name: University of Colorado, Denver
name: United States Department of Agriculture (USDA)
First posted: 2025-02-12
Enrollment: 140
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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:

1. 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.
2. 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.
3. 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.

Eligibility 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.

Primary outcomes:
measure: Intervention Fidelity: Observer Session Ratings
timeFrame: 6 weeks
measure: Intervention Fidelity: Facilitator Session Ratings
timeFrame: 6 weeks
measure: Intervention Acceptability: Questionnaire
timeFrame: 6 weeks
measure: Intervention Feasibility: Attendance
timeFrame: 6 weeks
Secondary outcomes:
measure: Intervention Acceptability: Qualitative Themes
timeFrame: 6 weeks
measure: Intervention Training Evaluation: Qualitative Themes
timeFrame: 6 months
measure: Intervention Training Fidelity: Facilitator Knowledge
timeFrame: 6 months
measure: Intervention Training Evaluation: Questionnaire
timeFrame: 6 months
measure: Emotional Regulation
timeFrame: 1 year
measure: Positive Youth Development
timeFrame: 1 year
measure: Dispositional Mindfulness
timeFrame: 1 year
measure: Eating behavior
timeFrame: 1 year
measure: Physical activity-engagement
timeFrame: 1 year
measure: Physical activity- self-confidence
timeFrame: 1 year
measure: Sleep Quality
timeFrame: 1 year
measure: Cardiometabolic health: Lipid profile and HbA1c
timeFrame: 1 year
measure: Daily glucose patterns
timeFrame: 1 year
measure: Blood pressure
timeFrame: 1 year
measure: Height
timeFrame: 1 year
measure: Weight
timeFrame: 1 year
measure: Body fat percentage
timeFrame: 1 year
measure: Activity Monitoring
timeFrame: 1 year
measure: Sleep Monitoring
timeFrame: 1 year
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Colorado State University
state: Colorado
Study officials:
affiliation: Colorado State University
name: Lauren B Shomaker, PhD
role: PRINCIPAL_INVESTIGATOR
References: