Trial Radar AI | ||
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De klinische studie NCT06822387 (HWB/SSB) voor Risicoreductie door levensstijl, Gezondheid van adolescenten, Gezondheidszorg voor gezinnen, Cardiometabole gezondheid, geestelijke gezondheid, Wellness Program, Type 2 diabetes, Obesitas bij adolescenten is rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
Health Without Barriers/Salud Sin Barreras- Northern Colorado (HWB/SSB) 140 Adolescenten Levensstijl
Growing an Extension Network for Multisite Dissemination and Implementation of Intensive Health Behavior and Lifestyle Treatment
- HWB/SSB
- 5952
Mindfulness
Wellness education
Nutrition
Physical Activity
Stress reduction
Health Without Barriers
Salud Sin Barreras
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelHealth without Barriers/ Salud Sin Barreras (HWB/SSB) HWB/SSB is a community-delivered, whole-family intensive health behavior and lifestyle intervention intended to reduce adolescent risk of chronic diseases (i.e., T2D) through promoting health behaviors and healthy stress management. The program is based on a lifestyle intervention called the Healthy Living Program (HeLP), a family-centered obesity prevention and treatment program for children. Previous and ongoing wo...Toon meer | Mindfulness-gebaseerde interventie Learning to BREATHE (L2B) is an evidence-based mindfulness 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. Ouderonderwijs The parent education curriculum includes 3 modules: 1) family support/parenting, 2) nutrition education and 3) physical activity education. Parents set weekly goals to implement what they learned in each session at home with their family. Lichamelijke activiteit Focuses on using cardio and resistance training to improve cardiorespiratory health in youth. Brief Mindfulness Intervention for Parents Parent-based mindfulness education is based on the Learning to BREATHE curriculum. Preschool Curriculum Preschool age children learn about and try new foods. Nutrition and Cooking Education Nutrition education and hands-on cooking lessons for the whole family. |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Intervention Fidelity: Observer Session Ratings | HWB delivery fidelity will be assessed as percentage adherence to the curriculum, determined by HWB trainers ratings of HWB sessions on a standardized checklist. The range is 0% (no adherence) to 100% (complete adherence), with higher scores reflecting better adherence | 6 weeks |
Intervention Fidelity: Facilitator Session Ratings | HWB delivery fidelity will be assessed as percentage adherence to the curriculum, determined by HWB facilitator ratings of HWB sessions on a standardized checklist. The range is 0% (no adherence) to 100% (complete adherence), with higher scores reflecting better adherence | 6 weeks |
Intervention Acceptability: Questionnaire | Participants rate and comment on each component of the program (i.e. parent education, physical fitness, mindfulness, etc.) separately. Participants are asked to report on how supported they 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 ratings can range from 1=not at all to 5=extremely, with higher scores reflecting better acceptability. | 6 weeks |
Intervention Feasibility: Attendance | Intervention feasibility will be assessed as percentage of family attendance of HWB sessions. The range is 0% (no attendance) to 100% (complete attendance), with higher scores reflecting better feasibility. | 6 weeks |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Intervention Acceptability: Qualitative Themes | Adolescents and parents will participate in focus groups post-intervention to discuss their overall experiences with the program and its components. The discussion will explore aspects that were beneficial, identify challenges, and highlight areas for improvement. Themes related to the acceptability of the intervention will be derived from the qualitative analysis of the focus groups. | 6 weeks |
Intervention Training Evaluation: Qualitative Themes | Facilitators will participate in focus groups to discuss their experiences with the training and facilitation process, including aspects that were beneficial, challenges or areas for improvement, their confidence in facilitating, and their experiences working with families. Themes related to the evaluation of the intervention will be derived from the qualitative analysis of the focus group discussions | 6 months |
Intervention Training Fidelity: Facilitator Knowledge | Facilitators will complete knowledge test following the completion of the facilitator training. The purpose of these tests is to assess their understanding and retention of key concepts, skills, and principles that facilitators need to effectively deliver the intervention. The range is 0% to 100% with 100% reflecting better training. | 6 months |
Intervention Training Evaluation: Questionnaire | Facilitators will rate and comment on the training process of the HWB program. Questions include topics about how supported facilitators felt during the training process, previous experience in facilitating group programs, confidence in facilitating after the training, and feedback on any recommended modifications to training procedures that they perceive would improve the training process. | 6 months |
Emotional 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. Items are rated on a 5-point scale that range from 1 ("Almost never") to 5 ("Almost always"). Items are summed to calculate both a total score and subscale scores for each of the six domains. Higher scores are more negative, suggesting a greater degree of emotional dysregulation. | 1 year |
Positive Youth Development | Positive Youth Development- Very Short Form, measures positive indicators of child well-being including competence, confidence, character, connection, and caring. This measures has 17 items which are responded to on a 5-point scale ranging from 1 ("Strongly disagree") to 5 ("Strongly agree"). Items are averaged to calculate both a total score and subscale scores for each domains. High scores in each domain indicate stronger, more positive perceptions or experiences of positive development in that area, and higher overall scores suggest a higher level of positive youth development across all domains. | 1 year |
Dispositional Mindfulness | Mindful Attention Awareness Scale (MAAS) measures an individual's present-moment attention in daily living (dispositional mindfulness). The MAAS has 15 items which are responded to on a 6-point scale ranging from 0 ("Almost always") to 6 ("Almost never"). Items are averaged to calculate a total score. Higher scores reflect higher levels of dispositional mindfulness. | 1 year |
Eating behavior | Reward-Based Eating Drive Scale (REDS), a reliable/valid survey instrument of hedonic eating (reward-based eating). The RED has 13 items which are responded to on a 5-point scale ranging from 0 ("Strongly Disagree") to 4 ("Strongly agree). Scores are summed to calculate a total score. Higher scores indicate to greater propensity for reward-related eating. | 1 year |
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. This form has 4 items which are responded to on a 5-point scale ranging from 1 ("No days") to 5 ("6-7 days"). Items are summed to calculate a total score. Higher scores indicate more frequent engagement in physical activity. | 1 year |
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. This measure has 8 items which are responded to on a 100-point percentage scale comprised of 10-point increments, ranging from 0% ("not at all confident") to 100% ("highly confident"). The total self-efficacy score is calculated by summing the confidence ratings for all items and dividing by the total number of items in the scale. This produces a score with a maximum possible value of 100, where higher scores indicate greater exercise self-confidence. | 1 year |
Sleep Quality | Pittsburgh Sleep Quality Index, self-rated questionnaire that assesses sleep quality and disturbances over a 1-month interval. The PSQI has 19 self-rated questions. The 19 self-rated items are used to calculate seven "component" scores, each ranging from 0 to 3 points. A score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The seven component scores are summed to generate a single "global" score, with a range from 0 to 21 points. A score of "0" indicates no difficulties, while a score of "21" reflects severe difficulties across all areas. Higher scores indicate lower (poorer) sleep quality. | 1 year |
Cardiometabolic health: Lipid profile and HbA1c | Finger prick by lancet is used to analyze HbA1c, HDL/LDL cholesterol, and triglycerides. | 1 year |
Daily glucose patterns | Continuous glucose monitoring is used to describe average daily glucose, peak glucose, standard deviation, and mean amplitude of glycemic excursions. | 1 year |
Blood pressure | Blood pressure is assessed via digital blood pressure monitor. | 1 year |
Height | Height will be measured in centimeters using a stadiometer during the in-person research visits. Height and weight will be combined to report a both non-fasted and fasted BMI in kg/m\^2. | 1 year |
Weight | Weight will be measured in using a calibrated scale at the in-person research visits. A fasting weight (10-hour overnight fast) using a smart scale for participants who opt-into this research activity. Weight and height will be combined to report both a non-fasted and fasted BMI in kg/m\^2. | 1 year |
Body fat percentage | Body fat percentage is measured using bioelectrical impedance analysis (BIA). | 1 year |
Activity Monitoring | Participants will be fitted with a ActiGraph wGT3X-BT and asked to wear the device for 7 days. | 1 year |
Sleep Monitoring | Participants will be fitted with a ActiGraph wGT3X-BT and asked to wear the device for 7 days. | 1 year |
Adolescent subjects
- Between the ages 11-19 years old
- Reside in Larimer County, Weld County, or the surrounding areas.
Parent/guardian subjects:
- 18 years old or older
- Are parents/guardians of an adolescent between the ages of 11-19
- Reside in Larimer County, Weld County, or the surrounding areas
Facilitators subjects
- 18 years old or older
- Reside in Larimer County, Weld County, or the surrounding areas
- Are planning to or have facilitated HWB
Parents/guardians will not take part in the 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).
There is no exclusion for facilitator subjects.
Colorado