Health Without Barriers/Salud Sin Barreras

Официальное название

Family-Inclusive Lifestyle Intervention for Teenagers in Rural Colorado

Обзор

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).

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Treatment Acceptability: Questionnaire [Срок оценки: 6 weeks]
• Intervention Acceptability: Qualitative Themes [Срок оценки: 6 weeks]

Вторичные конечные точки (12)

• Emotion regulation [Срок оценки: 1 year]
• Eating behavior [Срок оценки: 1 year]
• 24-hour dietary intake [Срок оценки: 1 year]
• Physical activity- engagement [Срок оценки: 1 year]
• Physical activity- self-confidence [Срок оценки: 1 year]
• Sleep disturbance [Срок оценки: 1 year]
• Cardiometabolic health [Срок оценки: 1 year]
• Daily glucose patterns [Срок оценки: 1 year]
• Blood Pressure [Срок оценки: 1 year]
• Height and Weight [Срок оценки: 1 year]
• Body Composition Measurement [Срок оценки: 1 year]
• Activity Monitoring [Срок оценки: 1 year]

Критерии участия

Критерии включения

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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 2 центра

• Colorado State University Extension — Durango
• Colorado State University — Fort Collins

Идентификаторы

NCT: NCT06052943 · 1883

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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