TrialGlobe

Clinical trial

Health Without Barriers/Salud Sin Barreras- Northern Colorado

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT06822387

Active, not recruitingNot applicableInterventional

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age11 Years to Not listed
SexAll
Healthy volunteersAccepted
ConditionLifestyle Risk Reduction, Adolescent Health, Family Health, Cardio-metabolic Health, Mental Health, Wellness Program, Type 2 Diabetes, Obesity, Adolescent

Full registry 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.

Treatments and study arms

Mindfulness-Based Intervention

Behavioral

Learning to BREATHE (L2B) is an evidence-based mindfulness curriculum for adolescents. L2B in this program consists of 6 sessions of approximately 1 hour per session. In between sessions, participants are asked to practice brief mindfulness skills individually.

Parent Education

Behavioral

The parent education curriculum includes 3 modules: 1) family support/parenting, 2) nutrition education and 3) physical activity education. Parents set weekly goals to implement what they learned in each session at home with their family.

Physical Activity

Behavioral

Focuses on using cardio and resistance training to improve cardiorespiratory health in youth.

Brief Mindfulness Intervention for Parents

Behavioral

Parent-based mindfulness education is based on the Learning to BREATHE curriculum.

Preschool Curriculum

Behavioral

Preschool age children learn about and try new foods.

Nutrition and Cooking Education

Behavioral

Nutrition education and hands-on cooking lessons for the whole family.

Primary outcomes

Intervention Fidelity: Observer Session Ratings6 weeks

HWB delivery fidelity will be assessed as percentage adherence to the curriculum, determined by HWB trainers ratings of HWB sessions on a standardized checklist. The range is 0% (no adherence) to 100% (complete adherence), with higher scores reflecting better adherence

Intervention Fidelity: Facilitator Session Ratings6 weeks

HWB delivery fidelity will be assessed as percentage adherence to the curriculum, determined by HWB facilitator ratings of HWB sessions on a standardized checklist. The range is 0% (no adherence) to 100% (complete adherence), with higher scores reflecting better adherence

Intervention Acceptability: Questionnaire6 weeks

Participants rate and comment on each component of the program (i.e. parent education, physical fitness, mindfulness, etc.) separately. Participants are asked to report on how supported they felt during the program, the helpfulness of the facilitators, the perceived benefits of program participation, and their overall experience participating in the program. This questionnaire will only be completed one time at the post-program follow-up. Intervention acceptability ratings can range from 1=not at all to 5=extremely, with higher scores reflecting better acceptability.

Intervention Feasibility: Attendance6 weeks

Intervention feasibility will be assessed as percentage of family attendance of HWB sessions. The range is 0% (no attendance) to 100% (complete attendance), with higher scores reflecting better feasibility.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Colorado State University🇺🇸 Fort Collins, Colorado, United States
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