Health Without Barriers/Salud Sin Barreras
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mindfulness-Based Intervention, Parent Education, Physical Activity, Brief Mindfulness Intervention for Parents.
- Who it may be relevant to
- Registry conditions: Mental Health Wellness, Family Research, Lifestyle Risk Reduction. Basic parameters: 11 years — 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Family-Inclusive Lifestyle Intervention for Teenagers in Rural Colorado
Overview
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
- 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. - 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. - 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
Primary outcome measures
- Treatment Acceptability: Questionnaire [Time frame: 6 weeks]
- Intervention Acceptability: Qualitative Themes [Time frame: 6 weeks]
Secondary outcome measures (12)
- 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]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 2 centers
- Colorado State University Extension — Durango
- Colorado State University — Fort Collins
Identifiers
NCT: NCT06052943 · 1883