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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

175

participants targeted

Target at P75+ for not_applicable

Timeline

13mo left

Started Sep 2022

Longer than P75 for not_applicable

Geographic Reach

1 country

2 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4.7 years study duration

Study Progress77%

Sep 2022Jun 2027

Study Start

First participant enrolled

September 21, 2022

Completed

11 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2023

Completed

1 month until next milestone

First Posted

Study publicly available on registry

September 25, 2023

Completed

3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

November 13, 2025

Status Verified

November 1, 2025

Enrollment Period

4.7 years

First QC Date

August 25, 2023

Last Update Submit

November 12, 2025

Conditions

Mental Health Wellness Family Research Lifestyle Risk Reduction

Outcome Measures

Primary Outcomes (2)

Treatment Acceptability: Questionnaire
Participants rate and comment on each component of the program (i.e. Cooking Matters, parent sessions, physical fitness sessions, Learning 2 BREATHE, dinners) separately. Questions include topics about how supported individuals 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.
6 weeks
Intervention Acceptability: Qualitative Themes
Themes indicative of acceptability of intervention obtained from qualitative analysis of participant and parent focus-groups at post-intervention.
6 weeks

Secondary Outcomes (13)

Emotion regulation
1 year
Eating behavior
1 year
24-hour dietary intake
1 year
Physical activity- engagement
1 year
Physical activity- self-confidence
1 year
+8 more secondary outcomes

Study Arms (1)

Health without Barriers/ Salud Sin Barreras

EXPERIMENTAL

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.

Behavioral: Mindfulness-Based InterventionBehavioral: Parent EducationBehavioral: Physical ActivityBehavioral: Brief Mindfulness Intervention for ParentsBehavioral: Preschool CurriculumBehavioral: Cooking Matters

Interventions

Mindfulness-Based InterventionBEHAVIORAL

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.

Also known as: Learning 2 BREATHE