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Behavioural Intervention

Lifestyle and Mindfulness Interventions for Mental Health Wellness

N/A

Recruiting

Research Sponsored by Colorado State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial aims to improve health outcomes in rural families through a tailored lifestyle intervention that focuses on mental health and healthy weight.

Who is the study for?

This trial is for families with at least one teenager aged 11-19 living in specific Colorado counties. It's not suitable for those with medical or psychological conditions that may pose a safety risk or hinder program benefits, such as severe emotional disturbances or substance abuse during sessions.Check my eligibility

What is being tested?

The study tests a family-based lifestyle and stress management program aimed at preventing chronic health issues like Type 2 Diabetes. It includes physical activities, nutritional education, parent guidance, and mindfulness techniques tailored to rural Southwest Colorado adolescents and their families.See study design

What are the potential side effects?

Since the interventions are non-medical (physical activity, nutrition education, etc.), side effects might include typical exercise-related discomforts like muscle soreness. Mindfulness practices could potentially cause temporary emotional discomfort if underlying issues surface.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Intervention Acceptability: Qualitative Themes

Treatment Acceptability: Questionnaire

Secondary outcome measures

24-hour dietary intake

Activity Monitoring

Blood Pressure

+10 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Health without Barriers/ Salud Sin BarrerasExperimental Treatment6 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mindfulness-Based Intervention

2020

N/A

~80

Parent Education

2016

N/A

~620

Physical Activity

2019

Completed Phase 3

~4710

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Colorado Health FoundationOTHER

2 Previous Clinical Trials

437 Total Patients Enrolled

Colorado State UniversityLead Sponsor

125 Previous Clinical Trials

38,184 Total Patients Enrolled

1 Trials studying Family Research

20 Patients Enrolled for Family Research

Colorado State University Extension-La Plata CountyUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment age limit for this medical research lower than 75 years?

"This trial is specifically seeking participants between 11 and 19 years old. There are also 9 clinical trials available for those below the age of majority, as well as 20 studies for patients aged 65 or above."

Answered by AI

Who can enroll in this experiment?

"To be eligible, research subjects must have family links and range between the ages of 11-19. This clinical trial is set to recruit 175 individuals in total."

Answered by AI

Are there any remaining openings for this research endeavor?

"Affirmative. Clinicaltrials.gov hosts information that reveals this clinical trial is actively recruiting individuals. It was first published on September 21st 2022 and most recently updated in September 19th 2023, seeking to enroll 175 participants at a single location."

Answered by AI

What is the size of the current cohort participating in this clinical trial?

"Affirmative. The clinicaltrials.gov listing for this research trial states that it is currently accepting new patients, having been initially posted on September 21st 2022 and recently updated on the 19th of September 2023. 175 people are required to be enrolled at a single medical centre."

Answered by AI

What results are researchers hoping to accomplish with this clinical experiment?

"The primary purpose of this 6-week clinical trial is to ascertain the acceptability of the intervention, as determined through qualitative themes. Secondary objectives involve assessing eating behaviour with Reward-Based Eating Drive Scale (REDS), 24hr dietary intake via NIH Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool, and physical activity engagement using NIH Patient-Reported Outcomes Measurement Information System (PROMIS): Pediatric Physical Activity - Short Form."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Health Without Barriers/Salud Sin Barreras

2022. "Health Without Barriers/Salud Sin Barreras". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06052943.