Skip to main content
Clinical Trials/NCT06052943
NCT06052943
Recruiting
Not Applicable

Family-Inclusive Lifestyle Intervention for Teenagers in Rural Colorado

Colorado State University2 sites in 1 country175 target enrollmentSeptember 21, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mental Health Wellness
Sponsor
Colorado State University
Enrollment
175
Locations
2
Primary Endpoint
Treatment Acceptability: Questionnaire
Status
Recruiting
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 21, 2022
End Date
June 1, 2027
Last Updated
5 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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).

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Emotion regulation(1 year)
  • Eating behavior(1 year)
  • 24-hour dietary intake(1 year)
  • Physical activity- engagement(1 year)
  • Physical activity- self-confidence(1 year)
  • Sleep disturbance(1 year)
  • Cardiometabolic health(1 year)
  • Daily glucose patterns(1 year)
  • Blood Pressure(1 year)
  • Height and Weight(1 year)
  • Body Composition Measurement(1 year)
  • Activity Monitoring(1 year)
  • Sleep Monitoring(1 year)

Study Sites (2)

Loading locations...

Similar Trials