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Health Without Barriers/Salud Sin Barreras

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06052943
Recruitment Status : Recruiting
First Posted : September 25, 2023
Last Update Posted : September 28, 2023
Sponsor:
Collaborators:
Colorado State University Extension-La Plata County
United States Department of Agriculture (USDA)
University of Colorado, Denver
Colorado Health Foundation
Information provided by (Responsible Party):
Colorado State University

Tracking Information
First Submitted Date  ICMJE August 25, 2023
First Posted Date  ICMJE September 25, 2023
Last Update Posted Date September 28, 2023
Actual Study Start Date  ICMJE September 21, 2022
Estimated Primary Completion Date June 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2023)
  • Treatment Acceptability: Questionnaire [ Time Frame: 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 [ Time Frame: 6 weeks ]
    Themes indicative of acceptability of intervention obtained from qualitative analysis of participant and parent focus-groups at post-intervention.
Original Primary Outcome Measures  ICMJE
 (submitted: September 19, 2023)
  • Treatment Acceptability: Questionnaire [ Time Frame: 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 [ Time Frame: 6 weeks ]
    Themes indicative of acceptability of intervention obtained from qualitative analysis of adolescent and parent focus-groups at post-intervention.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2023)
  • Emotion regulation [ Time Frame: 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 [ Time Frame: 1 year ]
    Reward-Based Eating Drive Scale (REDS), a reliable/valid survey instrument of hedonic eating
  • 24-hour dietary intake [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 year ]
    Finger prick by lancet is used to analyze HbA1c, HDL/LDL cholesterol, and triglycerides.
  • Daily glucose patterns [ Time Frame: 1 year ]
    Continuous glucose monitoring is used to describe average daily glucose, peak glucose, SD, and mean amplitude of glycemic excursions.
  • Blood Pressure [ Time Frame: 1 year ]
    Blood pressure assessed via digital blood pressure monitor.
  • Height and Weight [ Time Frame: 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 [ Time Frame: 1 year ]
    Body composition is measured using bioelectrical impedance analysis (BIA). BIA is performed using a validated bioelectrical impedance scale.
  • Activity Monitoring [ Time Frame: 1 year ]
    Participants will be fitted with a ActiGraph GT9X Link and asked to wear the device for 7 days.
  • Sleep Monitoring [ Time Frame: 1 year ]
    Participants will be fitted with a ActiGraph GT9X Link and asked to wear the device for 7 days.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2023)
  • Emotion regulation [ Time Frame: 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 [ Time Frame: 1 year ]
    Reward-Based Eating Drive Scale (REDS), a reliable/valid survey instrument of hedonic eating
  • 24-hour dietary intake [ Time Frame: 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 [ Time Frame: 1 year ]
    NIH Patient-Reported Outcomes Measurement Information System (PROMIS): Pediatric Physical Activity - Short Form, adolescents report on how many times, in the past 7 days, they engaged in different types of physical activity.
  • Physical activity- self-confidence [ Time Frame: 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 [ Time Frame: 1 year ]
    Adolescents will report on sleep using the 4-item PROMIS Pediatric Sleep Disturbance Short Form, in which they will indicate how often (on a scale of "never" to "always") in the past 7 days, they experienced disturbed sleep.
  • Cardiometabolic health [ Time Frame: 1 year ]
    Finger prick by lancet is used to analyze HbA1c, HDL/LDL cholesterol, and triglycerides.
  • Daily glucose patterns [ Time Frame: 1 year ]
    Continuous glucose monitoring is used to describe average daily glucose, peak glucose, SD, and mean amplitude of glycemic excursions.
  • Blood Pressure [ Time Frame: 1 year ]
    Blood pressure assessed via digital blood pressure monitor.
  • Height and Weight [ Time Frame: 1 year ]
    Weight will be measured via scale and height via stadiometer. These measures are used to calculate BMI percentile. Adolescents can choose to take part in a fasted weight measurement via scale.
  • Body Composition Measurement [ Time Frame: 1 year ]
    Body composition is measured using bioelectrical impedance analysis (BIA). BIA is performed using a validated bioelectrical impedance scale.
  • Activity Monitoring [ Time Frame: 1 year ]
    Adolescents will be fitted with a ActiGraph GT9X Link and asked to wear the device for 7 days.
  • Sleep Monitoring [ Time Frame: 1 year ]
    Adolescents will be fitted with a ActiGraph GT9X Link and asked to wear the device for 7 days.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Health Without Barriers/Salud Sin Barreras
Official Title  ICMJE Family-Inclusive Lifestyle Intervention for Teenagers in Rural Colorado
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Mental Health Wellness
  • Family Research
  • Lifestyle Risk Reduction
Intervention  ICMJE
  • Behavioral: Mindfulness-Based Intervention
    Learning 2 BREATHE (L2B) is an evidence based 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.
    Other Name: Learning 2 BREATHE
  • Behavioral: Parent Education
    The parent education curriculum includes 3 modules: 1) family support/parenting, 2) nutrition and 3) physical activity. The parents set weekly goals to implement the parent education lessons into everyday living.
  • Behavioral: Physical Activity
    Combines aerobic and resistance training though game play.
  • Behavioral: Brief Mindfulness Intervention for Parents
    Parent-based mindfulness education based on the Learning to BREATHE curriculum.
  • Behavioral: Preschool Curriculum
    Preschool age children learn about and try new foods.
  • Behavioral: Cooking Matters
    Nutrition education and hands-on cooking lessons for the whole family
Study Arms  ICMJE Experimental: Health without Barriers/ Salud Sin Barreras
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.
Interventions:
  • Behavioral: Mindfulness-Based Intervention
  • Behavioral: Parent Education
  • Behavioral: Physical Activity
  • Behavioral: Brief Mindfulness Intervention for Parents
  • Behavioral: Preschool Curriculum
  • Behavioral: Cooking Matters
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 19, 2023)
175
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2027
Estimated Primary Completion Date June 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Years to 19 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Lauren B Shomaker, PhD 970-491-3217 lauren.shomaker@colostate.edu
Contact: Nicole Clark, RDN 970-382-6461 nicole.clark@co.laplata.co.us
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06052943
Other Study ID Numbers  ICMJE 1883
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Colorado State University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Colorado State University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Colorado State University Extension-La Plata County
  • United States Department of Agriculture (USDA)
  • University of Colorado, Denver
  • Colorado Health Foundation
Investigators  ICMJE Not Provided
PRS Account Colorado State University
Verification Date September 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP