- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07859033
Feasibility of an Implementation Strategy for a Physical Activity Program in Rural Middle Schools
Feasibility of a Multilevel Implementation Strategy for a Sport-based Youth Development Physical Activity Program in Rural Middle Schools
The investigators aim to build on the pilot study data looking at the feasibility of implementation of Goal Setting alongside Hoosier Sport at two schools (Eastern Greene Middle School and White River Valley Middle School). The investigators plan to assess the effect of goal setting on physical activity engagement and psychological measures across the two schools. One school will receive the goal setting intervention in Fall while the other will receive it in Spring.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The study will assess the effect of goal setting on physical activity implementation strategy through a comparison of two rural middle schools: White River Valley (WRV) and Eastern Greene (EG). This will be a quasi-experimental, school-level crossover design. There will be an intervention semester and control semester at each school. For the intervention semester, Students will receive the 6-weeks of 30-minute small group sessions spent establishing and checking in on goals on a goal-setting worksheet. The program will be delivered during the school's lunch period. Students will get 15 minutes to eat prior to getting into their small groups to complete the goal-setting worksheet. The subjects will be able to eat throughout the group time as well. During this 6-week timeframe, participants will receive pedometers (step trackers) that the participants can wear throughout the duration of the goal setting program. Participants are not required to wear or use the pedometers to set their goals; however, participants will be encouraged to use the pedometer as a potential physical activity to set goals around (steps). At the end of the 6 weeks, participants will be asked to return the pedometer. With the goal setting worksheets, participants will set physical activity goals, track their progress, and check in on their goals throughout the program with members of the study team. Students will also complete all required data collection related to the study. Data collection will include both quantitative and qualitative measures and occur as follows: once the week before the group sessions start (with a survey inquiring about how participants feel toward physical activity and wearing an accelerometer for a 7 day period), the 6th week of the goal-setting sessions (students will wear the accelerometer for one more week), and the week after week 6 (students will complete a survey that includes questions about their experience with the goal-setting sessions and how participants feel toward physical activity). White River Valley will be the intervention school in Fall 2026 and Eastern Greene will be the intervention school in Spring 2027. Study procedures include an initial meeting to collect demographic information, introduce the intervention, and complete baseline assessments.
The non-intervention semester will be the control semester. During the control semester, participating students will receive a small health pamphlet with information on the benefits of physical activity and setting goals around physical activity. The participants will fill out two surveys during this semester (one at the beginning and one at the end) at a time chosen by the school and study team. This will take approximately 15-20 minutes to complete. Subjects will also wear accelerometers to track physical activity for 1 week around the time that each survey is completed. During the weeks in which participants are wearing the accelerometers, there will be a 'compliance check' once per week to ensure the accelerometers are actively being worn. This design ensures that data collected from both schools will inform the effectiveness of the implementation strategy and its impact on key clinical outcomes, such as physical activity levels and psychological health indicators. By comparing outcomes between WRV and EG, the study will evaluate whether goal setting alongside sport-based youth development programming improves children's physical activity levels and related health metrics in rural middle school settings.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
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Indiana
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Bloomfield, Indiana, États-Unis, 47424
- Recrutement
- Eastern Greene Middle School
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Contact:
- Nathan Martindale Athletic Director
- Numéro de téléphone: (812) 825-5010
- E-mail: nmartindale@egreene.k12.in.us
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Lyons, Indiana, États-Unis, 47443
- Recrutement
- White River Valley Middle School
-
Contact:
- Zack Waggoner Principal
- Numéro de téléphone: 812-659-3915
- E-mail: zwaggoner@wrv.k12.in.us
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Currently enrolled in 6th - 7th grade at White River Valley Middle School or Eastern Greene Middle School
- Have parental consent to participate
- Agree to study participation [verbal assent]
- Planning to attend all school days during the program period
- Be available for baseline and post-intervention measurement.
Exclusion Criteria:
- Have a medical condition that would interfere with the goal-setting program plan
- In treatment for a psychiatric disorder such that the intervention materials will not be appropriate.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Goal-Setting
The experimental group will participate in the Hoosier Sport program during their school's physical education class, which consists of sport curricula, leadership development, and health lessons. This group will complete this program with additional goal-setting programming. |
The intervention being tested is the addition of a goal-setting program during Hoosier Sport lessons. Students will receive 6-weeks of 30-minute small group sessions spent establishing and checking in on goals on a goal-setting worksheet |
|
Comparateur actif: No Goal-Setting/Control
The control group will participate in the Hoosier Sport program during their school's physical education class, which consists of sport curricula, leadership development, and health lessons. Participants will receive a goal-setting pamphlet; however, participants will not actively receive the goal-setting programming. |
This group will participate in Hoosier Sport lessons without goal-setting programming. Instead, students will receive a small health pamphlet with information on the benefits of physical activity and setting goals around physical activity. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Total Physical Activity
Délai: 7 days, prior to the start of the intervention & end of intervention. The same timeline occurs in the control semester.
|
Total physical activity measured by AX3 accelerometer at week 0 and week 6 of the goal-setting semester, reported in minutes per day. |
7 days, prior to the start of the intervention & end of intervention. The same timeline occurs in the control semester.
|
|
Self-Reported Physical Activity
Délai: 7 days, at the start of the control semester
|
Self-reported physical activity using the Global Student-Based Health Survey data at week 0. There are 9 questions. Each question is individually scored as follows:
|
7 days, at the start of the control semester
|
|
Self-Reported Physical Activity
Délai: 7 days, 6 weeks after the start of the intervention
|
Self-reported physical activity using the Global Student-Based Health Survey data at week 6. There are 9 questions. Each question is individually scored as follows:
|
7 days, 6 weeks after the start of the intervention
|
|
Light Physical Activity
Délai: 7 days, prior to the start of the intervention & end of intervention. The same timeline occurs in the control semester.
|
Light-intensity physical activity measured by AX3 accelerometer at week 0 and week 6 of the goal-setting semester, reported in minutes per day. |
7 days, prior to the start of the intervention & end of intervention. The same timeline occurs in the control semester.
|
|
Moderate Physical Activity
Délai: 7 days, prior to the start of the intervention & end of intervention. The same timeline occurs in the control semester.
|
Moderate-intensity physical activity measured by AX3 accelerometer at week 0 and week 6 of the goal-setting semester, reported in minutes per day. |
7 days, prior to the start of the intervention & end of intervention. The same timeline occurs in the control semester.
|
|
Vigorous Physical Activity
Délai: 7 days, prior to the start of the intervention & end of intervention. The same timeline occurs in the control semester.
|
Vigorous-intensity physical activity measured by AX3 accelerometer at week 0 and week 6 of the goal-setting semester, reported in minutes per day. |
7 days, prior to the start of the intervention & end of intervention. The same timeline occurs in the control semester.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Enjoyment of Physical Activity
Délai: 8 weeks
|
Participants will complete the Physical Activity Enjoyment Scale Short Version pre and post-intervention to determine how much participants enjoy physical activity. This is a 5-point Likert scale with 4 items, with answers ranging from 1 (Strongly disagree) to 5 (Strongly agree). Possible scores range from 1 to 5 with higher scores indicating greater physical activity enjoyment. |
8 weeks
|
|
Commitment to Physical Activity
Délai: 8 weeks
|
Participants will fill out the Commitment to Physical Activity Scale for Adolescents pre and post-intervention to determine their commitment to physical activity. |
8 weeks
|
|
Social Support for Exercise
Délai: 8 weeks
|
Participants will complete the Social Support and Exercise Survey pre and post intervention to assess perceived support from family and friends for physical activity participation. This is a 26 item 5-point Likert scale that ranges from 1 (Never) to 5 (Very Often). There are 3 subscales.
|
8 weeks
|
|
Athletic Identity
Délai: 8 weeks
|
Participants will complete the Athletic Identity Questionnaire (AIQ) pre and post intervention to assess their perception of themselves as physically active, including appearance, competence, and importance of physical activity. This is a 5-point Likert scale ranging from 1 (Strongly disagree) to 5 (Strongly agree). There are 6 subscales. For each subscale, higher scores indicate the following:
|
8 weeks
|
|
Motivation to Exercise
Délai: 8 weeks
|
Participants will complete the Intrinsic Motivation Inventory pre and post intervention to determine their levels of motivation to exercise. This includes 22 items with 7 different subscales. The minimum value is 1 and maximum value is 7. For subscales: Interest/Enjoyment, Perceived Competence, Perceived Choice, Effort/Importance, Value/Usefulness, and Relatedness - the higher the value, the greater intrinsic motivation. For subscale Pressure/Tension, the higher the value, the more anxiety present. |
8 weeks
|
|
Goal Attainment
Délai: 8 weeks
|
Participants will respond to a single-item Goal Attainment Scale post-intervention to assess how successful the subject feels in achieving their personal goals from 0% to 100%. Closer to 100% reflects greater attainment. |
8 weeks
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 31209
- 24CDA1038890 (Autre subvention/numéro de financement: American Heart Association)
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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