An interventional study of Mindfulness-Based Intervention and Parent Education in Mental Health Wellness, Family Research and Lifestyle Risk Reduction, sponsored by Colorado State University. Recruiting at 2 sites in United States. Open to participants aged 11 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-13.
Sponsored by Colorado State University · Not applicable, Interventional, and Prevention
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).
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.
291 studies on the registry are indexed under Risk Reduction Behavior; 39 are open to participants now.
This study's planned enrollment of 175 is below the median of 201 across 250 interventional studies indexed under Risk Reduction Behavior.
Browse Risk Reduction Behavior studies →Colorado State University is the lead sponsor of 117 studies on the registry; 19 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
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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:
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 Intervention · Behavioral: Parent Education · Behavioral: Physical Activity · Behavioral: Brief Mindfulness Intervention for Parents · Behavioral: Preschool Curriculum · Behavioral: Cooking Matters
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
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.
Combines aerobic and resistance training though game play.
Parent-based mindfulness education based on the Learning to BREATHE curriculum.
Preschool age children learn about and try new foods.
Nutrition education and hands-on cooking lessons for the whole family
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.
Time frame: 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.
Time frame: 6 weeks
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.
Time frame: 1 year
Eating behavior
Reward-Based Eating Drive Scale (REDS), a reliable/valid survey instrument of hedonic eating
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 year
Cardiometabolic health
Finger prick by lancet is used to analyze HbA1c, HDL/LDL cholesterol, and triglycerides.
Time frame: 1 year
Daily glucose patterns
Continuous glucose monitoring is used to describe average daily glucose, peak glucose, SD, and mean amplitude of glycemic excursions.
Time frame: 1 year
Blood Pressure
Blood pressure assessed via digital blood pressure monitor.
Time frame: 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.
Time frame: 1 year
Body Composition Measurement
Body composition is measured using bioelectrical impedance analysis (BIA). BIA is performed using a validated bioelectrical impedance scale.
Time frame: 1 year
Activity Monitoring
Participants will be fitted with a ActiGraph GT9X Link and asked to wear the device for 7 days.
Time frame: 1 year
Sleep Monitoring
Participants will be fitted with a ActiGraph GT9X Link and asked to wear the device for 7 days.
Time frame: 1 year
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Plan to share: No
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