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Health Without Barriers/Salud Sin Barreras

Family-Inclusive Lifestyle Intervention for Teenagers in Rural Colorado

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06052943
Enrollment
175
Registered
2023-09-25
Start date
2022-09-21
Completion date
2027-06-30
Last updated
2025-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Health Wellness, Family Research, Lifestyle Risk Reduction

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).

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.

Interventions

BEHAVIORALMindfulness-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.

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.

BEHAVIORALPhysical Activity

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.

BEHAVIORALCooking Matters

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

Sponsors

Colorado State University Extension-La Plata County
CollaboratorUNKNOWN
United States Department of Agriculture (USDA)
CollaboratorFED
University of Colorado, Denver
CollaboratorOTHER
Colorado Health Foundation
CollaboratorOTHER
Colorado State University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
11 Years to 19 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Treatment Acceptability: Questionnaire6 weeksParticipants 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 Themes6 weeksThemes indicative of acceptability of intervention obtained from qualitative analysis of participant and parent focus-groups at post-intervention.

Secondary

MeasureTime frameDescription
24-hour dietary intake1 yearNIH 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.
Physical activity- engagement1 yearNIH 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.
Physical activity- self-confidence1 yearExercise 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.
Sleep disturbance1 year4-item PROMIS Pediatric Sleep Disturbance Short Form, measures the frequency an individual experienced disturbed sleep in the past 7 days.
Cardiometabolic health1 yearFinger prick by lancet is used to analyze HbA1c, HDL/LDL cholesterol, and triglycerides.
Emotion regulation1 yearDifficulties 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.
Blood Pressure1 yearBlood pressure assessed via digital blood pressure monitor.
Height and Weight1 yearWeight 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.
Body Composition Measurement1 yearBody composition is measured using bioelectrical impedance analysis (BIA). BIA is performed using a validated bioelectrical impedance scale.
Activity Monitoring1 yearParticipants will be fitted with a ActiGraph GT9X Link and asked to wear the device for 7 days.
Sleep Monitoring1 yearParticipants will be fitted with a ActiGraph GT9X Link and asked to wear the device for 7 days.
Daily glucose patterns1 yearContinuous glucose monitoring is used to describe average daily glucose, peak glucose, SD, and mean amplitude of glycemic excursions.
Eating behavior1 yearReward-Based Eating Drive Scale (REDS), a reliable/valid survey instrument of hedonic eating

Countries

United States

Contacts

Primary ContactLauren B Shomaker, PhD
lauren.shomaker@colostate.edu970-491-3217
Backup ContactNicole Clark, RDN
nicole.clark@co.laplata.co.us970-382-6461

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026