Health Without Barriers/Salud Sin Barreras

Family-Inclusive Lifestyle Intervention for Teenagers in Rural Colorado

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).

Study Overview

• Status: Recruiting
• Conditions: Mental Health Wellness; Lifestyle Risk Reduction; Family Research
• Intervention / Treatment: Behavioral: Physical Activity; Behavioral: Brief Mindfulness Intervention for Parents; Behavioral: Preschool Curriculum; Behavioral: Cooking Matters; Behavioral: Mindfulness-Based Intervention; Behavioral: Parent Education

Detailed Description

Health Without Barriers/Salud Sin Barreras is a 12-session community-delivered, family-based lifestyle intervention for health promotion and reduction of risk for chronic diseases like T2D. The program is delivered over 6 weeks and includes family education/parent training, adolescent physical activity, mindfulness-based stress reduction training for adolescents, family meals, and family cooking/meal preparation. The goal is to deliver the program to up to 175 participants and their families over the course of 5 years (2022-2027). The program content and delivery/implementation processes already have been adapted based on information obtained through adolescent and parent interviews and community member voices though a 9-month community research collaboration. The investigators will gather new, additional information from program participants and stakeholders to continue to tailor the curriculum content and program processes. The investigators will do this iteratively using feedback collected during and in the wake of each cohort until thematic saturation is achieved (anticipated to be ~3 cohorts) and until the community-research partnership group has obtained program optimization for families in Southwest Colorado. Further, the investigators will conduct program evaluations of the adapted Health Without Barriers/Salud Sin Barreras program on changes in a range of indicators of mental/physical health and health behaviors in adolescents.

• Study Type: Interventional
• Enrollment (Estimated): 175
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lauren B Shomaker, PhD; Phone Number: 970-491-3217; Email: lauren.shomaker@colostate.edu
• Study Contact Backup: Name: Nicole Clark, RDN; Phone Number: 970-382-6461; Email: nicole.clark@co.laplata.co.us

Study Locations

• United States
  • Colorado
    • Durango, Colorado, United States, 81301
      • Recruiting
      • Colorado State University Extension
      • Contact: Nicole Clark, MS, RDN; Phone Number: 970-382-6461; Email: nicole.clark@co.laplata.co.us
    • Fort Collins, Colorado, United States, 80523
      • Active, not recruiting
      • Colorado State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Behavioral: Physical Activity; Combines aerobic and resistance training though game play.; Behavioral: Brief Mindfulness Intervention for Parents; Parent-based mindfulness education based on the Learning to BREATHE curriculum.; Behavioral: Preschool Curriculum; Preschool age children learn about and try new foods.; Behavioral: Cooking Matters; Nutrition education and hands-on cooking lessons for the whole family; Behavioral: 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.; Other Names: Learning 2 BREATHE; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotion regulation	Difficulties in Emotion Regulation Scale-Short Form (18 items), measures non-acceptance of emotional responses, difficulty engaging in goal-directed behavior, impulse control difficulties, lack of emotional awareness, limited access to emotion regulation strategies, and lack of emotional clarity.	1 year
Eating behavior	Reward-Based Eating Drive Scale (REDS), a reliable/valid survey instrument of hedonic eating	1 year
24-hour dietary intake	NIH Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool in order to assess dietary intake, including total energy intake, macronutrients, fruits/vegetable consumption, and overall quality of diet.	1 year
Physical activity- self-confidence	Exercise Self-Efficacy Scale, measures an individual's beliefs in their ability to continue exercising on a three time per week basis at moderate intensities for 40 or more minutes per session in the future.	1 year
Cardiometabolic health	Finger prick by lancet is used to analyze HbA1c, HDL/LDL cholesterol, and triglycerides.	1 year
Daily glucose patterns	Continuous glucose monitoring is used to describe average daily glucose, peak glucose, SD, and mean amplitude of glycemic excursions.	1 year
Blood Pressure	Blood pressure assessed via digital blood pressure monitor.	1 year
Body Composition Measurement	Body composition is measured using bioelectrical impedance analysis (BIA). BIA is performed using a validated bioelectrical impedance scale.	1 year
Physical activity- engagement	NIH Patient-Reported Outcomes Measurement Information System (PROMIS): Pediatric Physical Activity - Short Form, measures the number of times an individual engaged in different types of physical activity in the past 7 days.	1 year
Sleep disturbance	4-item PROMIS Pediatric Sleep Disturbance Short Form, measures the frequency an individual experienced disturbed sleep in the past 7 days.	1 year
Height and Weight	Weight will be measured via scale and height via stadiometer. These measures are used to calculate BMI percentile. Fasted weight measurement is taken via scale and is optional for participants.	1 year
Activity Monitoring	Participants will be fitted with a ActiGraph GT9X Link and asked to wear the device for 7 days.	1 year
Sleep Monitoring	Participants will be fitted with a ActiGraph GT9X Link and asked to wear the device for 7 days.	1 year

Collaborators and Investigators

• Sponsor: Colorado State University
• Collaborators: University of Colorado, Denver; United States Department of Agriculture (USDA); Colorado Health Foundation; Colorado State University Extension-La Plata County

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2022
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: August 25, 2023
• First Submitted That Met QC Criteria: September 19, 2023
• First Posted (Actual): September 25, 2023

Study Record Updates

• Last Update Posted (Estimated): November 13, 2025
• Last Update Submitted That Met QC Criteria: November 12, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Risk Reduction Behavior; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: 1883

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No