跳至主要内容
临床试验/NCT06052943
NCT06052943招募中不适用

Family-Inclusive Lifestyle Intervention for Teenagers in Rural Colorado

Colorado State University4 个研究点 分布在 1 个国家目标入组 175 人开始时间: 2022年9月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
175
试验地点
4
主要终点
Treatment Acceptability: Questionnaire

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
11 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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).

结局指标

主要结局

Treatment Acceptability: Questionnaire

时间窗: 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

时间窗: 6 weeks

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

次要结局

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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