Health Without Barriers/Salud Sin Barreras- Northern Colorado (HWB/SSB)

Growing an Extension Network for Multisite Dissemination and Implementation of Intensive Health Behavior and Lifestyle Treatment

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes; Obesity, Adolescent; Mental Health; Adolescent Health; Lifestyle Risk Reduction; Family Health; Wellness Program; Cardio-metabolic Health
• Intervention / Treatment: Behavioral: Preschool Curriculum; Behavioral: Mindfulness-Based Intervention; Behavioral: Parent Education; Behavioral: Physical Activity; Behavioral: Brief Mindfulness Intervention for Parents; Behavioral: Nutrition and Cooking Education

Detailed Description

Health Without Barriers/Salud Sin Barreras (HWB/SSB) is a 12-session community-delivered, whole-family intensive health behavior and lifestyle intervention for health promotion and reduction of risk for chronic diseases (e.g., type 2 diabetes). The program is delivered over 6 weeks and includes mindfulness-based stress reduction training for adolescents, parent/caregiver health education and mindfulness training, youth physical activity, and whole-family nutrition education and cooking/meal preparation. Previous and ongoing work has focused on gathering and using direct input from local community members and families from Southwest Colorado to adapt HWB/SSB to ensure cultural suitability for teenagers and their families in this region. Now, there is a need for further refinement of HWB/SSB community facilitator training and evaluation of the intervention. The HWB/SSB intervention delivery is NOT considered human subjects research; only the evaluation, dissemination, and implementation elements are considered research (objectives described below). The intervention will be delivered regardless of any research study, and participation in the research study is not a requirement for families to enroll in HWB/SSB or for facilitators to facilitate the intervention.

There are three main objectives to this study:

1. Train community-based facilitators for HWB/SSB and refine training through: (a) conducting a series of focus groups with facilitators (up to n=20), (b) facilitator completion of a knowledge tests before and after training, (c) facilitator completion of surveys to evaluate and refine training processes, and (d) monitoring fidelity of HWB delivery through completion of standardized checklists by HWB trainers of mock and live sessions and through facilitator fidelity surveys.
2. Enroll adolescents (up to n=60) and parents/caregivers (up to n=60) from Northern Colorado in HWB/SSB to evaluate the acceptability and feasibility of the program. Program acceptability will be assessed through a series of focus groups and acceptability surveys completed by the participants. Program attendance and retention will be used to assess feasibility.
3. Describe changes in adolescents' psychological, health behavior, and health-related outcomes from before to up to 1-year after HWB/SSB participation. Outcomes include: 1) cardiometabolic health, 2) stress management, 3) enjoyment, self-efficacy, and frequency of physical activity, 4) healthy eating behaviors, and 5) sleep health.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lauren B Shomaker, PhD; Phone Number: 970-491-3217; Email: lauren.shomaker@colostate.edu
• Study Contact Backup: Name: Natalia Sanchez, MPH; Phone Number: 970-491-1120; Email: natalia.sanchez@colostate.edu

Study Locations

• United States
  • Colorado
    • Fort Collins, Colorado, United States, 80523
      • Recruiting
      • Colorado State University
      • Contact: Natalia Sanchez, MPH; Phone Number: 970-491-1120; Email: natalia.sanchez@colostate.edu
      • Contact: Vicky Jimenez, BS; Phone Number: 970-286-5210; Email: vicky.jimenez@colostate.edu
      • Principal Investigator: Lauren B Shomaker, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Adolescent subjects

• Between the ages 11-19 years old
• Reside in Larimer County, Weld County, or the surrounding areas.

Parent/guardian subjects:

• 18 years old or older
• Are parents/guardians of an adolescent between the ages of 11-19
• Reside in Larimer County, Weld County, or the surrounding areas

Facilitators subjects

• 18 years old or older
• Reside in Larimer County, Weld County, or the surrounding areas
• Are planning to or have facilitated HWB

Exclusion Criteria

Adolescents subjects will not take part in the 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 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).

There is no exclusion for facilitator subjects.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Health without Barriers/ Salud Sin Barreras (HWB/SSB); 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: Preschool Curriculum; Preschool age children learn about and try new foods.; Behavioral: Mindfulness-Based Intervention; 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.; Behavioral: Parent Education; 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.; Behavioral: Physical Activity; Focuses on using cardio and resistance training to improve cardiorespiratory health in youth.; Behavioral: Brief Mindfulness Intervention for Parents; Parent-based mindfulness education is based on the Learning to BREATHE curriculum.; Behavioral: Nutrition and Cooking Education; Nutrition education and hands-on cooking lessons for the whole family.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks
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	6 months
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.	6 months
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.	6 months
Emotional Regulation	Difficulties in Emotion Regulation Scale-Short Form (18 items), measures non-acceptance of emotional responses, difficulty engaging in goal-directed behavior, impulse control difficulties, lack of emotional awareness, limited access to emotion regulation strategies, and lack of emotional clarity. Items are rated on a 5-point scale that range from 1 ("Almost never") to 5 ("Almost always"). Items are summed to calculate both a total score and subscale scores for each of the six domains. Higher scores are more negative, suggesting a greater degree of emotional dysregulation.	1 year
Positive Youth Development	Positive Youth Development- Very Short Form, measures positive indicators of child well-being including competence, confidence, character, connection, and caring. This measures has 17 items which are responded to on a 5-point scale ranging from 1 ("Strongly disagree") to 5 ("Strongly agree"). Items are averaged to calculate both a total score and subscale scores for each domains. High scores in each domain indicate stronger, more positive perceptions or experiences of positive development in that area, and higher overall scores suggest a higher level of positive youth development across all domains.	1 year
Dispositional Mindfulness	Mindful Attention Awareness Scale (MAAS) measures an individual's present-moment attention in daily living (dispositional mindfulness). The MAAS has 15 items which are responded to on a 6-point scale ranging from 0 ("Almost always") to 6 ("Almost never"). Items are averaged to calculate a total score. Higher scores reflect higher levels of dispositional mindfulness.	1 year
Eating behavior	Reward-Based Eating Drive Scale (REDS), a reliable/valid survey instrument of hedonic eating (reward-based eating). The RED has 13 items which are responded to on a 5-point scale ranging from 0 ("Strongly Disagree") to 4 ("Strongly agree). Scores are summed to calculate a total score. Higher scores indicate to greater propensity for reward-related eating.	1 year
Physical activity-engagement	NIH Patient-Reported Outcomes Measurement Information System (PROMIS): Pediatric Physical Activity - Short Form, measures the number of times an individual engaged in different types of physical activity in the past 7 days. This form has 4 items which are responded to on a 5-point scale ranging from 1 ("No days") to 5 ("6-7 days"). Items are summed to calculate a total score. Higher scores indicate more frequent engagement in physical activity.	1 year
Physical activity- self-confidence	Exercise Self-Efficacy Scale, measures an individual's beliefs in their ability to continue exercising on a three time per week basis at moderate intensities for 40 or more minutes per session in the future. This measure has 8 items which are responded to on a 100-point percentage scale comprised of 10-point increments, ranging from 0% ("not at all confident") to 100% ("highly confident"). The total self-efficacy score is calculated by summing the confidence ratings for all items and dividing by the total number of items in the scale. This produces a score with a maximum possible value of 100, where higher scores indicate greater exercise self-confidence.	1 year
Sleep Quality	Pittsburgh Sleep Quality Index, self-rated questionnaire that assesses sleep quality and disturbances over a 1-month interval. The PSQI has 19 self-rated questions. The 19 self-rated items are used to calculate seven "component" scores, each ranging from 0 to 3 points. A score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The seven component scores are summed to generate a single "global" score, with a range from 0 to 21 points. A score of "0" indicates no difficulties, while a score of "21" reflects severe difficulties across all areas. Higher scores indicate lower (poorer) sleep quality.	1 year
Cardiometabolic health: Lipid profile and HbA1c	Finger prick by lancet is used to analyze HbA1c, HDL/LDL cholesterol, and triglycerides.	1 year
Daily glucose patterns	Continuous glucose monitoring is used to describe average daily glucose, peak glucose, standard deviation, and mean amplitude of glycemic excursions.	1 year
Blood pressure	Blood pressure is assessed via digital blood pressure monitor.	1 year
Height	Height will be measured in centimeters using a stadiometer during the in-person research visits. Height and weight will be combined to report a both non-fasted and fasted BMI in kg/m^2.	1 year
Weight	Weight will be measured in using a calibrated scale at the in-person research visits. A fasting weight (10-hour overnight fast) using a smart scale for participants who opt-into this research activity. Weight and height will be combined to report both a non-fasted and fasted BMI in kg/m^2.	1 year
Body fat percentage	Body fat percentage is measured using bioelectrical impedance analysis (BIA).	1 year
Activity Monitoring	Participants will be fitted with a ActiGraph wGT3X-BT and asked to wear the device for 7 days.	1 year
Sleep Monitoring	Participants will be fitted with a ActiGraph wGT3X-BT and asked to wear the device for 7 days.	1 year

Collaborators and Investigators

• Sponsor: Colorado State University
• Collaborators: University of Colorado, Denver; United States Department of Agriculture (USDA); Colorado State University Extension-La Plata County; Colorado State University Extension-Larimer County; Colorado State University Extension-Weld County
• Investigators: Principal Investigator: Lauren B Shomaker, PhD, Colorado State University

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: November 4, 2024
• First Submitted That Met QC Criteria: February 6, 2025
• First Posted (Actual): February 12, 2025

Study Record Updates

• Last Update Posted (Actual): May 2, 2025
• Last Update Submitted That Met QC Criteria: April 29, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Physical Activity; Mindfulness; Nutrition; Stress reduction; Wellness education; Whole-family; Health Without Barriers; Salud Sin Barreras
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pediatric Obesity
• Other Study ID Numbers: 5952

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No