Financial Incentives to Exercise for Adolescents (MOVE)
25 de marzo de 2019 actualizado por: University of Oklahoma
Incentivizing Behavior: Promoting More Physical Activity in American Indian Youth
Among youth populations, American Indians have the highest prevalence of diabetes in the United States.
This study will use exercise as the principal lifestyle modification approach to reduce the risk of diabetes in this population.
The Choctaw Nation of Oklahoma has several excellent, but underutilized wellness facilities in their Health Services Area in rural Southeast Oklahoma, a low socioeconomic region.
It has been established that exercise lowers diabetes risk, and many overweight/obese, insulin resistant American Indian youth who live in this region would benefit from an increase in regular exercise.
The challenge is to modify behavior so that routine exercise is established and maintained.
The proposed study will test whether monetary incentives can elicit greater frequency and duration of exercise in American Indian youth when transportation and access barriers are reduced.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
Study participants in the intervention arm of the study will be asked to exercise on 3 days per week for 48 weeks.
Clinical and physical assessments will be performed at baseline and after 16, 32 and 48 weeks.
Participants will be randomized into one of two groups.
Each group will receive payment for exercise sessions completed but one group will be on a fixed schedule of compensation and the other will have a schedule that incentivizes frequency or duration of exercise.
In addition, two reference groups of age-matched participants who are normal weight and subclassified as having either low or high levels of physical activity and fitness will be tested.
The reference groups will complete baseline tests and will not enter the exercise intervention program.
Tipo de estudio
Intervencionista
Inscripción (Actual)
142
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Oklahoma
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Hugo, Oklahoma, Estados Unidos, 74743
- Choctaw Nation of Oklahoma Healthcare
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Talihina, Oklahoma, Estados Unidos, 74571
- Choctaw Nation Diabetes Wellness Center
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
11 años a 20 años (Niño, Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria for exercise intervention cohort:
- 11.0-20.9 years old
- overweight or obese
- family history of diabetes (primary or secondary relative)
- not in sports or exercise program (3 or fewer days per week of moderate-to-vigorous intensity physical activity, MVPA) for prior 3 months
- Tanner stage 2 or above
Inclusion Criteria for reference group cohort:
- 11.0-20.9 years old
- normal weight
- For low physical activity subgroup: not in sports or exercise program (3 or fewer days per week of MVPA) for prior 3 months
- For high physical activity subgroup: >30 minutes of structured MVPA on >3 days/week over the preceding 3 months
- Tanner stage 2 or above
Exclusion Criteria for all participants:
- metabolic, endocrine, cardiovascular, kidney disease
- orthopedic problems that limit physical activity
- medications or treatments that would interfere with the outcomes and interpretations
- smoking or tobacco use
- alcohol or illicit drug use
- pregnancy
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Standard payment, phase 1
All participants will perform exercise training.
Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes during weeks 1-16 (phase 1).
All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.
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All participants will perform exercise training at the wellness center.
Exercise duration and intensity will be recorded with heart rate monitors.
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Comparador activo: Standard payment, phase 2
All participants will perform exercise training.
Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes during weeks 17-32 (phase 2).
All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.
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All participants will perform exercise training at the wellness center.
Exercise duration and intensity will be recorded with heart rate monitors.
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Comparador activo: Ramp-down payment, phase 3
All participants will perform exercise training.
This phase will last from weeks 33-48 (phase 3).
Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes, but the value of the payments will decrease weekly (ramp-down) until reaching zero in week 41.
All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.
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All participants will perform exercise training at the wellness center.
Exercise duration and intensity will be recorded with heart rate monitors.
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Experimental: Incentivized payment, phase 1
All participants will perform exercise training.
Participants in this arm will receive an increasing amount of money when they increase exercise frequency (number of days) during weeks 1-16 (phase 1).
All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior
|
All participants will perform exercise training at the wellness center.
Exercise duration and intensity will be recorded with heart rate monitors.
|
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Experimental: Incentivized payment, phase 2
All participants will perform exercise training.
Participants in this arm will receive an increasing amount of money when they exercise for longer than 20 minutes per session during weeks 17-32 (phase 2).
All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior
|
All participants will perform exercise training at the wellness center.
Exercise duration and intensity will be recorded with heart rate monitors.
|
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Experimental: Raffle payment, phase 3
All participants will perform exercise training.
In weeks 33-48 (phase 3)participants in this arm will receive fewer financial incentives than in the prior 32 weeks but they will be delivered through a raffle system to utilize a variable reinforcement approach.
All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior.
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All participants will perform exercise training at the wellness center.
Exercise duration and intensity will be recorded with heart rate monitors.
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Sin intervención: Normal weight, low activity group
This group of participants will complete only the baseline tests and assessments and will serve as a reference group.
They will be selected to have low physical activity and fitness like the intervention group.
Therefore differences in their results with the intervention group will reflect the effects of overweight/obesity on the variables of interest.
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Sin intervención: Normal weight, high activity group
This group of participants will complete only the baseline tests and assessments and will serve as a reference group.
They will be selected to have higher physical activity and fitness than the intervention group.
They will therefore serve as a healthy reference group and differences in their results with the intervention group will reflect the effects of both overweight/obesity and physical activity on the variables of interest.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change From Baseline in Volume of Exercise (Total Time)
Periodo de tiempo: at baseline (week 0) and weeks 16, 32, and 48.
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Frequency and duration of moderate-to-vigorous physical activity will be measured using heart rate monitors.
The monitors will be worn each exercise session.
Participants are asked to complete 3 exercise sessions per week throughout the 48-week period of enrollment.
The primary comparison between the experimental and active comparator groups will be the volume of exercise (total time) accumulated.
Comparisons will be made for accumulated exercise volume at 16, 32, and 48 weeks and the change from baseline (week 0).
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at baseline (week 0) and weeks 16, 32, and 48.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Insulin Resistance
Periodo de tiempo: at baseline (week 0) and weeks 16, 32, and 48.
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Fasting blood glucose and insulin concentration will be measured and used to calculate the homeostatic model of assessment for insulin resistance (iHOMA2, %S).
Testing will be performed at baseline (week 0) and weeks 16, 32, and 48.
Data analysis will focus on the change from baseline and whether that change differs between groups.
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at baseline (week 0) and weeks 16, 32, and 48.
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Exercise Fitness
Periodo de tiempo: at baseline (week 0) and weeks 16, 32, and 48.
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Peak oxygen uptake (VO2max) during a progressive intensity bicycle test to fatigue.
Testing will be performed at baseline (week 0) and weeks 16, 32, and 48.
Data analysis will focus on the change from baseline and whether that change differs between groups.
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at baseline (week 0) and weeks 16, 32, and 48.
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Body Composition
Periodo de tiempo: at baseline (week 0) and weeks 16, 32, and 48.
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Body fat content.
Testing will be performed at baseline (week 0) and weeks 16, 32, and 48.
Data analysis will focus on the change from baseline and whether that change differs between groups.
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at baseline (week 0) and weeks 16, 32, and 48.
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Physical Activity
Periodo de tiempo: at baseline (week 0) and weeks 16, 32, and 48.
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Daily step counts measured with accelerometers.
Testing will be performed at baseline (week 0) and weeks 16, 32, and 48.
Data analysis will focus on the change from baseline and whether that change differs between groups.
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at baseline (week 0) and weeks 16, 32, and 48.
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Blood Lipids
Periodo de tiempo: at baseline (week 0) and weeks 16, 32, and 48.
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Standard assessment of fasting triglycerides.
Testing will be performed at baseline (week 0) and weeks 16, 32, and 48.
Data analysis will focus on the change from baseline and whether that change differs between groups.
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at baseline (week 0) and weeks 16, 32, and 48.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Kevin R Short, PhD, University of Oklahoma
- Investigador principal: Kenneth C Copeland, MD, University of Oklahoma
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de mayo de 2013
Finalización primaria (Actual)
1 de abril de 2017
Finalización del estudio (Actual)
1 de mayo de 2017
Fechas de registro del estudio
Enviado por primera vez
25 de abril de 2013
Primero enviado que cumplió con los criterios de control de calidad
6 de mayo de 2013
Publicado por primera vez (Estimar)
7 de mayo de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de abril de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
25 de marzo de 2019
Última verificación
1 de marzo de 2019
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- P20 MD000528-RP2
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