- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03837366
Evaluating Motivational Interviewing and Habit Formation to Enhance the Effect of Activity Trackers on Physical Activity
Evaluating Motivational Interviewing and Habit Formation to Enhance the Effect of Activity Trackers on Healthy Adults' Activity Levels: A Randomized Intervention
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The objective for this pilot study is to determine the efficacy of the Fitbit Charge wearable fitness monitor alone or in combination with additional behavior change strategies for increasing physical activity in inactive adults. A secondary objective is to assess the influence of psychosocial factors (e.g. self-efficacy, self-regulation, habit formation) on the effectiveness of this type of behavior change intervention. The central hypothesis is that use of the Fitbit will increase physical activity from baseline and that adding additional strategies will enhance this effect. This hypothesis is based on previous research demonstrating that continuous self- monitoring (using wearable technology) is effective in promotion of weight-loss in overweight and obese adults. This objective will be addressed through pursuing the following specific aims.
Aim 1: To determine the efficacy of using the Fitbit to increase physical activity behaviors and improve health markers in inactive adults. The working hypothesis is that wearing a Fitbit for 3 months will increase physical activity and improve health markers from baseline to follow-up in inactive adults.
Aim 2: To compare the efficacy of the Fitbit alone to the Fitbit in combination with behavior change strategies for increasing physical activity and improving psychosocial factors in inactive adults. The working hypothesis is that using the Fitbit along with behavior change strategies will lead to greater improvements in physical activity and psychosocial factors (self- motivation, self-regulation, self-efficacy, and social support) than using the Fitbit alone.
Aim 3: To assess the influence of individual differences in psychosocial variables on changes in physical activity over the intervention. The working hypothesis is that higher levels of self- motivation, self-regulation, self-efficacy, and social support at baseline will be predictive of greater improvements in physical activity over the intervention, regardless of group assignment.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Not meeting physical activity guidelines
Exclusion Criteria:
- Meeting physical activity guidelines
- Injury or condition that limits mobility
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Activity Tracker with Health Coaching
Participants assigned to this condition will receive a Fitbit activity tracker to use for 3 months.
Also, they will be asked to come in for a visit approximately one week following baseline assessments.
Using the principles of Motivational Interviewing and Habit Formation, participants will discuss their perceived benefits and barriers of becoming more physically active with a member of the research team.
They will also be encouraged to set a goal related to using their Fitbit to increase their physical activity.
Lastly, they will be given information regarding habit formation and encouraged to identify one or more cues that regularly occur in their daily life to check their Fitbit data as a prompt to engage in physical activity.
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Use of an activity tracker alone or in combination with health coaching on physical activity behaviors.
Autres noms:
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Comparateur actif: Activity Tracker alone
Participants assigned to this condition will use their Fitbit on their own for the duration of 3- month intervention, similar to the experience of participants buying the device off-the-shelf.
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Use of an activity tracker alone or in combination with health coaching on physical activity behaviors.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Steps
Délai: 3 months
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Average steps accumulated per day assessed via the activPAL
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3 months
|
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Moderate and Vigorous Physical Activity
Délai: 3 months
|
Average minutes per day assessed via a combination of activPAL and ActiGraph
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3 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Habit Development
Délai: 3 months
|
Measured via the Automaticity Index of the Self-Reported Habit Index.
The Self-Reported Habit Index consists of 12 items and the Automaticity Subscale includes 4 of these 12.
Each item is scored on a 5-point (0-4) Likert scale with anchors ranging from strongly disagree (0) to strongly agree (4).
As such, scores for the Automaticity Index range from 0-16 with higher scores indicating stronger habits.
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3 months
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Laura D Ellingson-Sayen, PhD, Iowa State University
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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
Autres numéros d'identification d'étude
- LEllingson_Fitbit_Intervention
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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