Recruiting

Health Without Barriers

Sponsor:

Colorado State University

Code:

NCT06052943

Conditions

Mental Health Wellness

Family Research

Lifestyle Risk Reduction

Eligibility Criteria

Sex: All

Age: 11 - 19

Healthy Volunteers: Accepted

Interventions

Mindfulness-Based Intervention

Parent Education

Physical Activity

Brief Mindfulness Intervention for Parents

Preschool Curriculum

Study Details

Brief summary:

The goal of this study is to address a key health inequity - lack of community access to evidence-based programs to prevent chronic health conditions (e.g., Type 2 Diabetes) - by tailoring and delivering a family-based lifestyle and stress management intervention, Health Without Barriers/Salud Sin Barreras, for adolescents and their families living in rural Southwest Colorado. The intervention is a lifestyle program that addresses healthy lifestyle habits within the family context to support adolescent mental health (mindfulness intervention) and healthy weight (physical activity, nutrition, and parent education).

Conditions

Mental Health Wellness

Family Research

Lifestyle Risk Reduction

Study ID

NCT06052943

Start date

Sep 21, 2022

Status verified date

Nov, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 19

Healthy Volunteers: Accepted

Inclusion Criteria:

Families must have at least 1 teen that is between the ages of 11-19 years old and reside in La Plata, Montezuma, or Archuleta Counties.

Exclusion Criteria:

  • Participants will not take part in the program and/or 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 program and/or 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).

Study Design

Enrollment

175 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Health without Barriers/ Salud Sin Barreras

Health Without Barriers/Salud Sin Barreras is 12-session community-delivered, family-based lifestyle intervention to reduction the risk of for chronic diseases (i.e., T2D) in adolescence and to improve whole family health and wellness. The program is based upon a lifestyle intervention called the Healthy Living Program (HeLP), which includes 6 weekly 2 hour nutrition/cooking sessions through Cooking Matters and 6 weekly 2 hour Multidisciplinary Sessions that include parent education, a teen and sibling (ages 6-10 years) group physical fitness class, preschool curriculum for children 2-5 years of age, and a teen mindfulness curriculum called Learning 2 BREATHE. Health Without Barriers/Salud Sin Barreras has been tailored for adolescents at risk for depression and chronic diseases (i.e., T2D) in Southwest Colorado based on community input.

Interventions

Mindfulness-Based Intervention

Learning 2 BREATHE (L2B) is an evidence based 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

The parent education curriculum includes 3 modules: 1) family support/parenting, 2) nutrition and 3) physical activity. The parents set weekly goals to implement the parent education lessons into everyday living.

Physical Activity

Combines aerobic and resistance training though game play.

Brief Mindfulness Intervention for Parents

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

Preschool Curriculum

Preschool age children learn about and try new foods.

Cooking Matters

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

Primary outcome measure

  • Treatment Acceptability: Questionnaire [ Time Frame: 6 weeks ]
  • Intervention Acceptability: Qualitative Themes [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Lauren B Shomaker, PhD

970-491-3217lauren.shomaker@colostate.edu

Nicole Clark, RDN

970-382-6461nicole.clark@co.laplata.co.us

Locations

Colorado State University Extension

Recruiting

Durango, Colorado, United States, 81301

Contacts

Nicole Clark, MS, RDN

970-382-6461nicole.clark@co.laplata.co.us

More Information

Sponsor

Colorado State University

Last update posted

Nov 13, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Colorado State University on 2025-11-13.