Financial Incentives to Exercise for Adolescents (MOVE)
25 mars 2019 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
142
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
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Oklahoma
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Hugo, Oklahoma, États-Unis, 74743
- Choctaw Nation of Oklahoma Healthcare
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Talihina, Oklahoma, États-Unis, 74571
- Choctaw Nation Diabetes Wellness Center
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
11 ans à 20 ans (Enfant, Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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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Comparateur actif: 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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Comparateur actif: 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.
|
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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Expérimental: 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.
|
|
Expérimental: 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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Expérimental: 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.
|
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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Aucune intervention: 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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Aucune intervention: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change From Baseline in Volume of Exercise (Total Time)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Insulin Resistance
Délai: at baseline (week 0) and weeks 16, 32, and 48.
|
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
Délai: 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
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Physical Activity
Délai: at baseline (week 0) and weeks 16, 32, and 48.
|
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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Kevin R Short, PhD, University of Oklahoma
- Chercheur principal: Kenneth C Copeland, MD, University of Oklahoma
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 mai 2013
Achèvement primaire (Réel)
1 avril 2017
Achèvement de l'étude (Réel)
1 mai 2017
Dates d'inscription aux études
Première soumission
25 avril 2013
Première soumission répondant aux critères de contrôle qualité
6 mai 2013
Première publication (Estimation)
7 mai 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
3 avril 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
25 mars 2019
Dernière vérification
1 mars 2019
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- P20 MD000528-RP2
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