Clinical trial NCT06052943: Health Without Barriers/Salud Sin Barreras
Official title: Family-Inclusive Lifestyle Intervention for Teenagers in Rural Colorado
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health Wellness
Family Research
Lifestyle Risk Reduction
Lead sponsor: Colorado State University
Sponsor class: OTHER
Collaborators: name: Colorado State University Extension-La Plata County
name: United States Department of Agriculture (USDA)
name: University of Colorado, Denver
name: Colorado Health Foundation
First posted: 2023-09-25
Enrollment: 175
Sex: ALL
Minimum age (years): 11
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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).

Primary outcomes:
measure: Treatment Acceptability: Questionnaire
timeFrame: 6 weeks
measure: Intervention Acceptability: Qualitative Themes
timeFrame: 6 weeks
Secondary outcomes:
measure: Emotion regulation
timeFrame: 1 year
measure: Eating behavior
timeFrame: 1 year
measure: 24-hour dietary intake
timeFrame: 1 year
measure: Physical activity- engagement
timeFrame: 1 year
measure: Physical activity- self-confidence
timeFrame: 1 year
measure: Sleep disturbance
timeFrame: 1 year
measure: Cardiometabolic health
timeFrame: 1 year
measure: Daily glucose patterns
timeFrame: 1 year
measure: Blood Pressure
timeFrame: 1 year
measure: Height and Weight
timeFrame: 1 year
measure: Body Composition Measurement
timeFrame: 1 year
measure: Activity Monitoring
timeFrame: 1 year
measure: Sleep Monitoring
timeFrame: 1 year
Other outcomes:
Locations:
city: Durango
country: United States
facility: Colorado State University Extension
state: Colorado
city: Fort Collins
country: United States
facility: Colorado State University
state: Colorado
Study officials:
References: