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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.
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Kaartweergave

Health Without Barriers/Salud Sin Barreras- Northern Colorado (HWB/SSB) 140 Adolescenten Levensstijl

Rekruterend
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De klinische studie NCT06822387 (HWB/SSB) is een interventioneel studie bij Risicoreductie door levensstijl, Gezondheid van adolescenten, Gezondheidszorg voor gezinnen, Cardiometabole gezondheid, geestelijke gezondheid, Wellness Program, Type 2 diabetes, Obesitas bij adolescenten met de status rekruterend. Het doel is om 140 deelnemers te includeren vanaf 7 april 2025. De studie wordt geleid door Colorado State University en de voltooiing is gepland op 30 juni 2026. Laatste update op ClinicalTrials.gov: 2 mei 2025.
Beknopte samenvatting
The overarching goal of this work is to address the limited access to evidence-based health behavior and lifestyle interventions for youth and families most impacted by preventable chronic diseases, including obesity and type 2 diabetes. In the current project, we implement a small single-arm pilot and feasibility trial of Health Without Barriers/Salud Sin Barreras (HWB/SSB), a culturally-adapted, whole-family intens...Toon meer
Uitgebreide beschrijving
Health Without Barriers/Salud Sin Barreras (HWB/SSB) is a 12-session community-delivered, whole-family intensive health behavior and lifestyle intervention for health promotion and reduction of risk for chronic diseases (e.g., type 2 diabetes). The program is delivered over 6 weeks and includes mindfulness-based stress reduction training for adolescents, parent/caregiver health education and mindfulness training, you...Toon meer
Officiële titel

Growing an Extension Network for Multisite Dissemination and Implementation of Intensive Health Behavior and Lifestyle Treatment

Aandoeningen
Risicoreductie door levensstijlGezondheid van adolescentenGezondheidszorg voor gezinnenCardiometabole gezondheidgeestelijke gezondheidWellness ProgramType 2 diabetesObesitas bij adolescenten
Andere studie-ID's
  • HWB/SSB
  • 5952
NCT-ID
Startdatum (Werkelijk)
2025-04-07
Laatste update geplaatst
2025-05-02
Verwachte einddatum
2026-06-30
Inschrijving (Geschat)
140
Studietype
Interventioneel
FASE
N.v.t.
Status
Rekruterend
Trefwoorden
Whole-family
Mindfulness
Wellness education
Nutrition
Physical Activity
Stress reduction
Health Without Barriers
Salud Sin Barreras
Primaire doel
Preventie
Toewijzing
N.v.t.
Interventiemodel
Enkele groep
Blindering
Geen (Open-label)
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/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.
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
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
Secundaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
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
Deelname-assistent
Geschiktheidscriteria

Leeftijd van deelnemers
Kind, Volwassene, Oudere volwassene
Minimumleeftijd
11 Years
Geslachten die in aanmerking komen voor de studie
Allen
Accepteert gezonde vrijwilligers
Ja

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

Adolescents subjects 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 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 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 State University logoColorado State University
Centraal Contactpersoon
Contact: Lauren B Shomaker, PhD, 970-491-3217, [email protected]
Contact: Natalia Sanchez, MPH, 970-491-1120, [email protected]
1 Studielocaties in 1 landen

Colorado

Colorado State University, Fort Collins, Colorado, 80523, United States
Natalia Sanchez, MPH, Contact, 970-491-1120, [email protected]
Vicky Jimenez, BS, Contact, 970-286-5210, [email protected]
Lauren B Shomaker, PhD, Hoofdonderzoeker
Rekruterend