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
|Condition or disease||Intervention/treatment||Phase|
|Mental Health Wellness Family Research Lifestyle Risk Reduction||Behavioral: Mindfulness-Based Intervention Behavioral: Parent Education Behavioral: Physical Activity Behavioral: Brief Mindfulness Intervention for Parents Behavioral: Preschool Curriculum Behavioral: Cooking Matters||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||175 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Family-Inclusive Lifestyle Intervention for Teenagers in Rural Colorado|
|Actual Study Start Date :||September 21, 2022|
|Estimated Primary Completion Date :||June 2027|
|Estimated Study Completion Date :||June 2027|
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.
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
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06052943
|Contact: Lauren B Shomaker, PhDfirstname.lastname@example.org|
|Contact: Nicole Clark, RDNemail@example.com|
|United States, Colorado|
|Colorado State University Extension||Recruiting|
|Durango, Colorado, United States, 81301|
|Contact: Nicole Clark, MS, RDN 970-382-6461 firstname.lastname@example.org|
|Colorado State University||Active, not recruiting|
|Fort Collins, Colorado, United States, 80523|