Mental Health WellnessNCT06052943
Health Without Barriers/Salud Sin Barreras
A study testing Mindfulness-Based Intervention, Parent Education and Physical Activity in people with Mental Health Wellness and Family Research, run by Colorado State University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 11 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness, Family Research, Lifestyle Risk Reduction
- What is being tested?
- Mindfulness-Based Intervention, Parent Education and Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Sep 2022to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Recruiting
Colorado State University Extension
Durango, Colorado, 81301
Nicole Clark, MS, RDN, 970-382-6461, nicole.clark@co.laplata.co.us
- Active, not recruiting
Colorado State University
Fort Collins, Colorado, 80523
About this study
Official title: 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).
Read the 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.
- Being tested
- Mindfulness-Based Intervention, Parent Education, Physical Activity, Brief Mindfulness Intervention for Parents, Preschool Curriculum
- Medical subject headings
- Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based InterventionBehavioural
Also called Learning 2 BREATHE
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 EducationBehavioural
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 ActivityBehavioural
Combines aerobic and resistance training though game play.
Brief Mindfulness Intervention for ParentsBehavioural
Parent-based mindfulness education based on the Learning to BREATHE curriculum.
Preschool CurriculumBehavioural
Preschool age children learn about and try new foods.
Cooking MattersBehavioural
Nutrition education and hands-on cooking lessons for the whole family
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mindfulness-Based Intervention; Behavioral: Parent Education; Behavioral: Physical Activity; Behavioral: Brief Mindfulness Intervention for Parents; Behavioral: Preschool Curriculum; Behavioral: Cooking Matters |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 weeks
Secondary outcomes (13)
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.
Measured: 1 year
Eating behavior
Reward-Based Eating Drive Scale (REDS), a reliable/valid survey instrument of hedonic eating
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Cardiometabolic health
Finger prick by lancet is used to analyze HbA1c, HDL/LDL cholesterol, and triglycerides.
Measured: 1 year
Daily glucose patterns
Continuous glucose monitoring is used to describe average daily glucose, peak glucose, SD, and mean amplitude of glycemic excursions.
Measured: 1 year
Blood Pressure
Blood pressure assessed via digital blood pressure monitor.
Measured: 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.
Measured: 1 year
Body Composition Measurement
Body composition is measured using bioelectrical impedance analysis (BIA). BIA is performed using a validated bioelectrical impedance scale.
Measured: 1 year
Activity Monitoring
Participants will be fitted with a ActiGraph GT9X Link and asked to wear the device for 7 days.
Measured: 1 year
Sleep Monitoring
Participants will be fitted with a ActiGraph GT9X Link and asked to wear the device for 7 days.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start21 Sep 2022
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health WellnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- Colorado State University Extension-La Plata County, United States Department of Agriculture (USDA), University of Colorado, Denver, Colorado Health Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06052943
- Sponsor's protocol ID
- 1883
- Status last verified
- Nov 2025
- First submitted
- 25 Aug 2023
- Last updated
- 13 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-Inclusive Lifestyle Intervention for Teenagers in Rural Colorado
- ClinicalTrials.gov ID
- NCT06052943
- Acronym / sponsor ID
- 1883
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- Colorado State University Extension-La Plata County, United States Department of Agriculture (USDA), University of Colorado, Denver, Colorado Health Foundation
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health without Barriers/ Salud Sin Barreras | Experimental | Behavioral: Mindfulness-Based Intervention, Behavioral: Parent Education, Behavioral: Physical Activity, Behavioral: Brief Mindfulness Intervention for Parents, Behavioral: Preschool Curriculum, Behavioral: Cooking MattersHealth 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. |
Who may qualify
- Ages
- 11 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based InterventionAlso: Learning 2 BREATHELearning 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. | Behavioural | Health without Barriers/ Salud Sin Barreras |
| Parent EducationThe 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. | Behavioural | Health without Barriers/ Salud Sin Barreras |
| Physical ActivityCombines aerobic and resistance training though game play. | Behavioural | Health without Barriers/ Salud Sin Barreras |
| Brief Mindfulness Intervention for ParentsParent-based mindfulness education based on the Learning to BREATHE curriculum. | Behavioural | Health without Barriers/ Salud Sin Barreras |
| Preschool CurriculumPreschool age children learn about and try new foods. | Behavioural | Health without Barriers/ Salud Sin Barreras |
| Cooking MattersNutrition education and hands-on cooking lessons for the whole family | Behavioural | Health without Barriers/ Salud Sin Barreras |
Primary outcome
Treatment Acceptability: Questionnaire
Time frame: 6 weeks
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.
Intervention Acceptability: Qualitative Themes
Time frame: 6 weeks
Themes indicative of acceptability of intervention obtained from qualitative analysis of participant and parent focus-groups at post-intervention.
13 secondary outcomes
Emotion regulation
Time frame: 1 year
Eating behavior
Time frame: 1 year
24-hour dietary intake
Time frame: 1 year
Physical activity- engagement
Time frame: 1 year
Physical activity- self-confidence
Time frame: 1 year
Sleep disturbance
Time frame: 1 year
Cardiometabolic health
Time frame: 1 year
Daily glucose patterns
Time frame: 1 year
Blood Pressure
Time frame: 1 year
Height and Weight
Time frame: 1 year
Body Composition Measurement
Time frame: 1 year
Activity Monitoring
Time frame: 1 year
Sleep Monitoring
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Mental Health Wellness
Not yet recruiting
A Hybrid Effectiveness-Implementation and Cost-Utility Evaluation of a Support Programme for Informal Carers of People With Dementia in Primary Care (EsCuidar2)
Quality of Life
Active, not recruitingObservational study
Gulf Long-Term Follow-Up Study
Cardiovascular Disease, Hematologic Diseases
Not yet recruiting
Supporting Health and Empowerment Through Contingency Management and Affect Regulation
HIV Risk
Not yet recruiting
Pilot Study to Co-create and Implement a Multicomponent Intervention to Reduce Mental Health Stigma in Primary Care
Mental Health, Stigma of Mental Illness
Not yet recruitingObservational study
A Natural History of Cardiometabolic Disease Among US Bhutanese: Developing the Cross-Sectional Bhutanese Community of Central Ohio Health Study to Understand Acculturation as Synergizing Socioenvironmental and Biobehavioral Risk Factors Propagating ...
Cardiometabolic Risk Factors, Mental Health
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Intervention, Parent Education and Physical Activity in people with Mental Health Wellness and Family Research, run by Colorado State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauren B Shomaker, PhD (970-491-3217, lauren.shomaker@colostate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Acceptability: Questionnaire (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2025.