Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

140

participants targeted

Target at P50-P75 for not_applicable

Timeline

2mo left

Started Apr 2025

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.2 years study duration

Study Progress88%

Apr 2025Jun 2026

First Submitted

Initial submission to the registry

November 4, 2024

Completed

3 months until next milestone

First Posted

Study publicly available on registry

February 12, 2025

Completed

2 months until next milestone

Study Start

First participant enrolled

April 7, 2025

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

May 2, 2025

Status Verified

April 1, 2025

Enrollment Period

1.2 years

First QC Date

November 4, 2024

Last Update Submit

April 29, 2025

Conditions

Lifestyle Risk Reduction Adolescent Health Family Health Cardio-metabolic Health Mental Health Wellness Program Type 2 Diabetes Obesity, Adolescent

Keywords

Whole-familyMindfulnessWellness educationNutritionPhysical ActivityStress reductionHealth Without BarriersSalud Sin Barreras

Outcome Measures

Primary Outcomes (4)

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
6 weeks
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
6 weeks
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.
6 weeks
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.
6 weeks

Secondary Outcomes (19)

Intervention Acceptability: Qualitative Themes
6 weeks
Intervention Training Evaluation: Qualitative Themes
6 months
Intervention Training Fidelity: Facilitator Knowledge
6 months
Intervention Training Evaluation: Questionnaire
6 months
Emotional Regulation
1 year
+14 more secondary outcomes

Study Arms (1)

Health without Barriers/ Salud Sin Barreras (HWB/SSB)

EXPERIMENTAL

HWB/SSB is a community-delivered, whole-family intensive health behavior and lifestyle intervention intended to reduce adolescent risk of chronic diseases (i.e., T2D) through promoting health behaviors and healthy stress management. The program is based on a lifestyle intervention called the Healthy Living Program (HeLP), a family-centered obesity prevention and treatment program for children. Previous and ongoing work has focused on tailoring HWB/SSB implementation to ensure cultural suitability for adolescents and their families in Southwest Colorado. HWB/SSB emphasizes "whole family" involvement including the participation of siblings, elders, other caregivers, and relatives. HWB/SSB is delivered. The HWB/SSB intervention delivery is not considered human subjects research; only the evaluation, dissemination, and implementation elements are considered research. The intervention will be delivered regardless of any research activity.

Behavioral: Mindfulness-Based InterventionBehavioral: Parent EducationBehavioral: Physical ActivityBehavioral: Brief Mindfulness Intervention for ParentsBehavioral: Preschool CurriculumBehavioral: Nutrition and Cooking Education

Interventions

Mindfulness-Based InterventionBEHAVIORAL

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.