Health Without Barriers/Salud Sin Barreras

Lifestyle Risk Reduction Clinical Trial

Official title:

Family-Inclusive Lifestyle Intervention for Teenagers in Rural Colorado

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06052943
• Other study ID #: 1883
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2022
• Est. completion date: June 2027

Study information

• Verified date: September 2023
• Source: Colorado State University
• Contact: Lauren B Shomaker, PhD
• Phone: 970-491-3217
• Email: lauren.shomaker[@]colostate.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 175
• Est. completion date: June 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 19 Years

Eligibility

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).

Related Conditions & MeSH terms

• Family Research
• Lifestyle Risk Reduction
• Mental Health Wellness

Intervention

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.
• 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.
• Physical Activity
Combines aerobic and resistance training though game play.
• Brief Mindfulness Intervention for Parents
Parent-based mindfulness education based on the Learning to BREATHE curriculum.
• Preschool Curriculum
Preschool age children learn about and try new foods.
• Cooking Matters
Nutrition education and hands-on cooking lessons for the whole family

Locations

Country	Name	City	State
United States	Colorado State University Extension	Durango	Colorado
United States	Colorado State University	Fort Collins	Colorado

Sponsors (5)

Lead Sponsor	Collaborator
Colorado State University	Colorado Health Foundation, Colorado State University Extension-La Plata County, United States Department of Agriculture (USDA), University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Acceptability: Questionnaire	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.	6 weeks
Primary	Intervention Acceptability: Qualitative Themes	Themes indicative of acceptability of intervention obtained from qualitative analysis of participant and parent focus-groups at post-intervention.	6 weeks
Secondary	Emotion 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.	1 year
Secondary	Eating behavior	Reward-Based Eating Drive Scale (REDS), a reliable/valid survey instrument of hedonic eating	1 year
Secondary	24-hour dietary intake	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.	1 year
Secondary	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.	1 year
Secondary	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.	1 year
Secondary	Sleep disturbance	4-item PROMIS Pediatric Sleep Disturbance Short Form, measures the frequency an individual experienced disturbed sleep in the past 7 days.	1 year
Secondary	Cardiometabolic health	Finger prick by lancet is used to analyze HbA1c, HDL/LDL cholesterol, and triglycerides.	1 year
Secondary	Daily glucose patterns	Continuous glucose monitoring is used to describe average daily glucose, peak glucose, SD, and mean amplitude of glycemic excursions.	1 year
Secondary	Blood Pressure	Blood pressure assessed via digital blood pressure monitor.	1 year
Secondary	Height and Weight	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.	1 year
Secondary	Body Composition Measurement	Body composition is measured using bioelectrical impedance analysis (BIA). BIA is performed using a validated bioelectrical impedance scale.	1 year
Secondary	Activity Monitoring	Participants will be fitted with a ActiGraph GT9X Link and asked to wear the device for 7 days.	1 year
Secondary	Sleep Monitoring	Participants will be fitted with a ActiGraph GT9X Link and asked to wear the device for 7 days.	1 year