- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Indiana
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Bloomfield, Indiana, Estados Unidos, 47424
- Reclutamiento
- Eastern Greene Middle School
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Contacto:
- Nathan Martindale Athletic Director
- Número de teléfono: (812) 825-5010
- Correo electrónico: nmartindale@egreene.k12.in.us
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Lyons, Indiana, Estados Unidos, 47443
- Reclutamiento
- White River Valley Middle School
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Contacto:
- Zack Waggoner Principal
- Número de teléfono: 812-659-3915
- Correo electrónico: zwaggoner@wrv.k12.in.us
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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 |
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Comparador activo: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Total Physical Activity
Periodo de tiempo: 7 days, prior to the start of the intervention & end of intervention. The same timeline occurs in the control semester.
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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.
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Self-Reported Physical Activity
Periodo de tiempo: 7 days, at the start of the control semester
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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:
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7 days, at the start of the control semester
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Self-Reported Physical Activity
Periodo de tiempo: 7 days, 6 weeks after the start of the intervention
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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:
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7 days, 6 weeks after the start of the intervention
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Light Physical Activity
Periodo de tiempo: 7 days, prior to the start of the intervention & end of intervention. The same timeline occurs in the control semester.
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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.
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Moderate Physical Activity
Periodo de tiempo: 7 days, prior to the start of the intervention & end of intervention. The same timeline occurs in the control semester.
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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.
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Vigorous Physical Activity
Periodo de tiempo: 7 days, prior to the start of the intervention & end of intervention. The same timeline occurs in the control semester.
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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.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Enjoyment of Physical Activity
Periodo de tiempo: 8 weeks
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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
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Commitment to Physical Activity
Periodo de tiempo: 8 weeks
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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
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Social Support for Exercise
Periodo de tiempo: 8 weeks
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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.
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8 weeks
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Athletic Identity
Periodo de tiempo: 8 weeks
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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:
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8 weeks
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Motivation to Exercise
Periodo de tiempo: 8 weeks
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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
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Goal Attainment
Periodo de tiempo: 8 weeks
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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
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 31209
- 24CDA1038890 (Otro número de subvención/financiamiento: American Heart Association)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
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