Health Without Barriers/Salud Sin Barreras

Not Applicable

Recruiting

• Conditions: Family Research; Mental Health Wellness; Lifestyle Risk Reduction
• Interventions: Behavioral: Mindfulness-Based Intervention; Behavioral: Parent Education; Behavioral: Physical Activity; Behavioral: Brief Mindfulness Intervention for Parents; Behavioral: Preschool Curriculum; Behavioral: Cooking Matters

• Registration Number: NCT06052943
• Lead Sponsor: Colorado State University

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.

Study Timeline

• Study Start: 2022-09-21
• Study First Submitted: 2023-08-25
• Study First Submitted QC: 2023-09-19
• Study First Posted: 2023-09-25
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-09
• Last Update Posted: 2024-10-10
• Primary Completion: 2027-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 175

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Health without Barriers/ Salud Sin Barreras	Mindfulness-Based Intervention	Health Without Barriers/Salud Sin Barreras is 12-session community-delivered, family-based lifestyle intervention to reduction the risk of for chronic diseases (i.e., T2D) in adolescence and to improve whole family health and wellness. The program is based upon a lifestyle intervention called the Healthy Living Program (HeLP), which includes 6 weekly 2 hour nutrition/cooking sessions through Cooking Matters and 6 weekly 2 hour Multidisciplinary Sessions that include parent education, a teen and sibling (ages 6-10 years) group physical fitness class, preschool curriculum for children 2-5 years of age, and a teen mindfulness curriculum called Learning 2 BREATHE. Health Without Barriers/Salud Sin Barreras has been tailored for adolescents at risk for depression and chronic diseases (i.e., T2D) in Southwest Colorado based on community input.
Health without Barriers/ Salud Sin Barreras	Preschool Curriculum	Health Without Barriers/Salud Sin Barreras is 12-session community-delivered, family-based lifestyle intervention to reduction the risk of for chronic diseases (i.e., T2D) in adolescence and to improve whole family health and wellness. The program is based upon a lifestyle intervention called the Healthy Living Program (HeLP), which includes 6 weekly 2 hour nutrition/cooking sessions through Cooking Matters and 6 weekly 2 hour Multidisciplinary Sessions that include parent education, a teen and sibling (ages 6-10 years) group physical fitness class, preschool curriculum for children 2-5 years of age, and a teen mindfulness curriculum called Learning 2 BREATHE. Health Without Barriers/Salud Sin Barreras has been tailored for adolescents at risk for depression and chronic diseases (i.e., T2D) in Southwest Colorado based on community input.
Health without Barriers/ Salud Sin Barreras	Cooking Matters	Health Without Barriers/Salud Sin Barreras is 12-session community-delivered, family-based lifestyle intervention to reduction the risk of for chronic diseases (i.e., T2D) in adolescence and to improve whole family health and wellness. The program is based upon a lifestyle intervention called the Healthy Living Program (HeLP), which includes 6 weekly 2 hour nutrition/cooking sessions through Cooking Matters and 6 weekly 2 hour Multidisciplinary Sessions that include parent education, a teen and sibling (ages 6-10 years) group physical fitness class, preschool curriculum for children 2-5 years of age, and a teen mindfulness curriculum called Learning 2 BREATHE. Health Without Barriers/Salud Sin Barreras has been tailored for adolescents at risk for depression and chronic diseases (i.e., T2D) in Southwest Colorado based on community input.
Health without Barriers/ Salud Sin Barreras	Brief Mindfulness Intervention for Parents	Health Without Barriers/Salud Sin Barreras is 12-session community-delivered, family-based lifestyle intervention to reduction the risk of for chronic diseases (i.e., T2D) in adolescence and to improve whole family health and wellness. The program is based upon a lifestyle intervention called the Healthy Living Program (HeLP), which includes 6 weekly 2 hour nutrition/cooking sessions through Cooking Matters and 6 weekly 2 hour Multidisciplinary Sessions that include parent education, a teen and sibling (ages 6-10 years) group physical fitness class, preschool curriculum for children 2-5 years of age, and a teen mindfulness curriculum called Learning 2 BREATHE. Health Without Barriers/Salud Sin Barreras has been tailored for adolescents at risk for depression and chronic diseases (i.e., T2D) in Southwest Colorado based on community input.
Health without Barriers/ Salud Sin Barreras	Parent Education	Health Without Barriers/Salud Sin Barreras is 12-session community-delivered, family-based lifestyle intervention to reduction the risk of for chronic diseases (i.e., T2D) in adolescence and to improve whole family health and wellness. The program is based upon a lifestyle intervention called the Healthy Living Program (HeLP), which includes 6 weekly 2 hour nutrition/cooking sessions through Cooking Matters and 6 weekly 2 hour Multidisciplinary Sessions that include parent education, a teen and sibling (ages 6-10 years) group physical fitness class, preschool curriculum for children 2-5 years of age, and a teen mindfulness curriculum called Learning 2 BREATHE. Health Without Barriers/Salud Sin Barreras has been tailored for adolescents at risk for depression and chronic diseases (i.e., T2D) in Southwest Colorado based on community input.
Health without Barriers/ Salud Sin Barreras	Physical Activity	Health Without Barriers/Salud Sin Barreras is 12-session community-delivered, family-based lifestyle intervention to reduction the risk of for chronic diseases (i.e., T2D) in adolescence and to improve whole family health and wellness. The program is based upon a lifestyle intervention called the Healthy Living Program (HeLP), which includes 6 weekly 2 hour nutrition/cooking sessions through Cooking Matters and 6 weekly 2 hour Multidisciplinary Sessions that include parent education, a teen and sibling (ages 6-10 years) group physical fitness class, preschool curriculum for children 2-5 years of age, and a teen mindfulness curriculum called Learning 2 BREATHE. Health Without Barriers/Salud Sin Barreras has been tailored for adolescents at risk for depression and chronic diseases (i.e., T2D) in Southwest Colorado based on community input.

Primary Outcome Measures

Name	Time	Method
Treatment Acceptability: Questionnaire	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	6 weeks	Themes indicative of acceptability of intervention obtained from qualitative analysis of participant and parent focus-groups at post-intervention.

Secondary Outcome Measures

Name	Time	Method
Emotion regulation	1 year	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.
Eating behavior	1 year	Reward-Based Eating Drive Scale (REDS), a reliable/valid survey instrument of hedonic eating
24-hour dietary intake	1 year	NIH Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool in order to assess dietary intake, including total energy intake, macronutrients, fruits/vegetable consumption, and overall quality of diet.
Physical activity- engagement	1 year	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.
Physical activity- self-confidence	1 year	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.
Sleep disturbance	1 year	4-item PROMIS Pediatric Sleep Disturbance Short Form, measures the frequency an individual experienced disturbed sleep in the past 7 days.
Cardiometabolic health	1 year	Finger prick by lancet is used to analyze HbA1c, HDL/LDL cholesterol, and triglycerides.
Daily glucose patterns	1 year	Continuous glucose monitoring is used to describe average daily glucose, peak glucose, SD, and mean amplitude of glycemic excursions.
Blood Pressure	1 year	Blood pressure assessed via digital blood pressure monitor.
Height and Weight	1 year	Weight will be measured via scale and height via stadiometer. These measures are used to calculate BMI percentile. Fasted weight measurement is taken via scale and is optional for participants.
Body Composition Measurement	1 year	Body composition is measured using bioelectrical impedance analysis (BIA). BIA is performed using a validated bioelectrical impedance scale.
Activity Monitoring	1 year	Participants will be fitted with a ActiGraph GT9X Link and asked to wear the device for 7 days.
Sleep Monitoring	1 year	Participants will be fitted with a ActiGraph GT9X Link and asked to wear the device for 7 days.

Trial Locations

Locations (2)

Colorado State University Extension; 🇺🇸 Durango, Colorado, United States

Colorado State University; 🇺🇸 Fort Collins, Colorado, United States