Health Without Barriers/Salud Sin Barreras- Northern Colorado

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age11+
SponsorColorado State University

About this trial

The overarching goal of this work is to address the limited access to evidence-based health behavior and lifestyle interventions for youth and families most impacted by preventable chronic diseases, including obesity and type 2 diabetes. In the current project, we implement a small single-arm pilot and feasibility trial of Health Without Barriers/Salud Sin Barreras (HWB/SSB), a culturally-adapted, whole-family intensive health behavior and lifestyle intervention to 11-19-year-old adolescents and their families living in Northern Colorado. Objectives are refining the HWB/SSB community facilitator training, evaluating the feasibility and acceptability of HWB/SSB implementation, and characterizing changes in health outcomes among adolescent participants.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Between the ages 11-19 years old

Reside in Larimer County, Weld County, or the surrounding areas.

18 years old or older

Are parents/guardians of an adolescent between the ages of 11-19

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Mindfulness-Based Intervention

    Behavioral

    Learning to BREATHE (L2B) is an evidence-based mindfulness 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.

  • Parent Education

    Behavioral

    The parent education curriculum includes 3 modules: 1) family support/parenting, 2) nutrition education and 3) physical activity education. Parents set weekly goals to implement what they learned in each session at home with their family.

  • Physical Activity

    Behavioral

    Focuses on using cardio and resistance training to improve cardiorespiratory health in youth.

  • Brief Mindfulness Intervention for Parents

    Behavioral

    Parent-based mindfulness education is based on the Learning to BREATHE curriculum.

  • Preschool Curriculum

    Behavioral

    Preschool age children learn about and try new foods.

  • Nutrition and Cooking Education

    Behavioral

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

Treatment groups

140 Participants
are divided into 1 treatment group
Group A: Health without Barriers/ Salud Sin Barreras (HWB/SSB)Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Intervention Fidelity: Observer Session Ratings

HWB delivery fidelity will be assessed as percentage adherence to the curriculum, determined by HWB trainers ratings of HWB sessions on a standardized checklist. The range is 0% (no adherence) to 100% (complete adherence), with higher scores reflecting better adherence

Time frame
6 weeks
2

Intervention Fidelity: Facilitator Session Ratings

HWB delivery fidelity will be assessed as percentage adherence to the curriculum, determined by HWB facilitator ratings of HWB sessions on a standardized checklist. The range is 0% (no adherence) to 100% (complete adherence), with higher scores reflecting better adherence

Time frame
6 weeks
3

Intervention Acceptability: Questionnaire

Participants rate and comment on each component of the program (i.e. parent education, physical fitness, mindfulness, etc.) separately. Participants are asked to report on how supported they 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 ratings can range from 1=not at all to 5=extremely, with higher scores reflecting better acceptability.

Time frame
6 weeks
4

Intervention Feasibility: Attendance

Intervention feasibility will be assessed as percentage of family attendance of HWB sessions. The range is 0% (no attendance) to 100% (complete attendance), with higher scores reflecting better feasibility.

Time frame
6 weeks

Secondary outcomes

1

Intervention Acceptability: Qualitative Themes

Adolescents and parents will participate in focus groups post-intervention to discuss their overall experiences with the program and its components. The discussion will explore aspects that were beneficial, identify challenges, and highlight areas for improvement. Themes related to the acceptability of the intervention will be derived from the qualitative analysis of the focus groups.

Time frame
6 weeks
2

Intervention Training Evaluation: Qualitative Themes

Facilitators will participate in focus groups to discuss their experiences with the training and facilitation process, including aspects that were beneficial, challenges or areas for improvement, their confidence in facilitating, and their experiences working with families. Themes related to the evaluation of the intervention will be derived from the qualitative analysis of the focus group discussions

Time frame
6 months
3

Intervention Training Fidelity: Facilitator Knowledge

Facilitators will complete knowledge test following the completion of the facilitator training. The purpose of these tests is to assess their understanding and retention of key concepts, skills, and principles that facilitators need to effectively deliver the intervention. The range is 0% to 100% with 100% reflecting better training.

Time frame
6 months
4

Intervention Training Evaluation: Questionnaire

Facilitators will rate and comment on the training process of the HWB program. Questions include topics about how supported facilitators felt during the training process, previous experience in facilitating group programs, confidence in facilitating after the training, and feedback on any recommended modifications to training procedures that they perceive would improve the training process.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Colorado State University

Lead sponsor

Colorado State University Extension-Larimer County

Collaborator

Colorado State University Extension-Weld County

Collaborator

Colorado State University Extension-La Plata County

Collaborator

University of Colorado, Denver

Collaborator

United States Department of Agriculture (USDA)

Collaborator