Health TrialsbyHealthPanel

Health Without Barriers/Salud Sin Barreras

ConditionsMental Health WellnessFamily ResearchLifestyle Risk Reduction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age11-19
SponsorColorado State University

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • Mindfulness-Based Intervention

    Behavioral

    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

    Behavioral

    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

    Behavioral

    Combines aerobic and resistance training though game play.

  • Brief Mindfulness Intervention for Parents

    Behavioral

    Parent-based mindfulness education based on the Learning to BREATHE curriculum.

  • Preschool Curriculum

    Behavioral

    Preschool age children learn about and try new foods.

  • Cooking Matters

    Behavioral

    Nutrition education and hands-on cooking lessons for the whole family

Treatment groups

175 Participants
are divided into 1 treatment group
Group A: Health without Barriers/ Salud Sin BarrerasExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
6 weeks
2

Intervention Acceptability: Qualitative Themes

Themes indicative of acceptability of intervention obtained from qualitative analysis of participant and parent focus-groups at post-intervention.

Time frame
6 weeks

Secondary outcomes

1

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.

Time frame
1 year
2

Eating behavior

Reward-Based Eating Drive Scale (REDS), a reliable/valid survey instrument of hedonic eating

Time frame
1 year
3

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.

Time frame
1 year
4

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.

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Colorado State University

Lead sponsor

Colorado State University Extension-La Plata County

Collaborator

United States Department of Agriculture (USDA)

Collaborator

University of Colorado, Denver

Collaborator

Colorado Health Foundation

Collaborator

Source ClinicalTrials.gov
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