- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02574689
Home-based, Individually-tailored Physical Activity Print Intervention for African American Women in the Deep South (HIPP)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
80 women will receive the HIPP Intervention or Wellness Contact Control. While main outcomes are focused on feasibility and acceptability, physical activity, fitness, and body weight and composition data will be collected at baseline, 6 months, and 12 months, along with blood draws.
HIPP Intervention: The physical activity intervention is based on the Social Cognitive Theory and Transtheoretical Model and, emphasizes behavioral strategies for increasing activity levels (i.e., goal-setting, self-monitoring, problem-solving barriers, increasing social support, rewarding oneself for meeting physical activity goals), and includes regular mailings (three mailings in month 1, two mailings in months 2 and 3, one mailing in months 4, 5, 6, 8, and 10) of physical activity manuals that are matched to the participant's current level of motivational readiness and individually-tailored computer expert system feedback reports. Computer expert system feedback reports will be based on participants' monthly update survey data and include information on:
- current stage of motivational readiness for physical activity;
- increasing self- efficacy (i.e., confidence) for physical activity participation;
- weighing the pros and cons of engaging in physical activity (decisional balance);
- social support from family and friends for physical activity participation;
- outcome expectations (beliefs regarding the consequences of physical activity participation);
- perceived enjoyment of physical activity;
- how the participant compares to her prior responses (progress feedback);
- how the participant compares to individuals who are physically active and with national guidelines (normative feedback);
- self monitoring of physical activity behavior (using pedometers and activity logs to track the total steps and minutes of moderate intensity physical activity per day).
The computer expert system draws from a bank of 330 messages addressing different levels of psychosocial and environmental factors affecting physical activity. Intervention participants will also receive tip sheets addressing physical activity barriers specific to African American women in the Deep South (as identified during our focus groups and comprehensive literature review).
Wellness Contact Control Condition: Cancer prevention information on topics other than physical activity (e.g., "Add Fruits and Veggies to Your Diet") from the American Cancer Society (ACS) website (www.cancer.org) will be mailed to control participants at the same time points that the HIPP Intervention participants receive their physical activity intervention materials.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Alabama
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Birmingham, Alabama, États-Unis, 35233
- University of Alabama at Birmingham
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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:
- African American
- Post-menopausal (defined as not having menstrual periods for at least 12 months)
- Not taking hormone replacement therapy
- Healthy (BMI 18.5-40; No history of heart disease, myocardial infarction, angina, stroke, or orthopedic conditions which limit mobility, or any serious medical condition that would make physical activity unsafe; no psychiatric hospitalization in past 3 years).
- Not taking medication that may impair physical activity tolerance or performance (e.g., beta blockers).
- Not planning to move from the area for the next 12 months
- Willing to be randomized to either study arm and adhere to study protocol
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: HIPP Intervention
The physical activity intervention emphasizes behavioral strategies for increasing activity levels (i.e., goal-setting, self-monitoring, problem-solving barriers, increasing social support, rewarding oneself for meeting physical activity goals), and includes regular mailings (three mailings in month 1, two mailings in months 2 and 3, one mailing in months 4, 5, 6, 8, and 10) of physical activity manuals that are matched to the participant's current level of motivational readiness and individually-tailored computer expert system feedback reports.
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The physical activity intervention is based on the Social Cognitive Theory and Transtheoretical Model and includes motivation-matched physical activity manuals and individually-tailored computer expert system feedback reports.
Tailored reports are based on participants' monthly update survey data and cover: 1) current stage of change; 2) self-efficacy; 3) decisional balance; 4) social support; 5) outcome expectations; 6) enjoyment; 7) progress feedback; 8) normative feedback; 9) self regulation.
The computer expert system draws from a bank of 330 messages addressing different levels of psychosocial and environmental factors affecting physical activity.
|
Comparateur actif: Wellness Contact Control
Cancer prevention information on topics other than physical activity (e.g., "Add Fruits and Veggies to Your Diet") from the ACS website (www.cancer.org)
will be mailed to control participants at the same time points that the HIPP Intervention participants receive their physical activity intervention materials.
|
Cancer prevention information on topics other than physical activity (e.g., "Add Fruits and Veggies to Your Diet") from the American Cancer Society website (www.cancer.org)
are mailed to control participants at the same time points that the HIPP Intervention participants receive their physical activity intervention materials.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
7-Day Physical activity Recall interview (change from baseline in 7-Day physical activity recall interview)
Délai: baseline and 6 months
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minutes/week of moderate intensity or greater physical activity
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baseline and 6 months
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7-Day Physical activity Recall interview (change from baseline in 7-Day physical activity recall interview)
Délai: baseline and 12 months
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minutes/week of moderate intensity or greater physical activity
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baseline and 12 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
6 minute walk test
Délai: baseline, 6 months, 12 months
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meters walked in 6 minutes
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baseline, 6 months, 12 months
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body mass index
Délai: baseline, 6 months, 12 months
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kg/m^2
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baseline, 6 months, 12 months
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waist circumference
Délai: baseline, 6 months, 12 months
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cm
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baseline, 6 months, 12 months
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body impedance analyses
Délai: baseline, 6 months, 12 months
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% body fat
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baseline, 6 months, 12 months
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Social Support for exercise scale
Délai: baseline, 6 months, 12 months
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range=0-65 for both friends and family subscales, with higher scores indicating more social support
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baseline, 6 months, 12 months
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Outcome expectations scale
Délai: baseline, 6 months, 12 months
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range= 1-5, with higher scores representing more outcome expectations
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baseline, 6 months, 12 months
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Physical Activity Enjoyment scale
Délai: baseline, 6 months, 12 months
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range=18-126, with higher scores indicating more enjoyment
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baseline, 6 months, 12 months
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accelerometers
Délai: baseline, 6 months, 12 months
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minutes/week of moderate intensity or greater physical activity
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baseline, 6 months, 12 months
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Stages of Readiness Measure
Délai: baseline, 6 months, 12 months
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categorize participants into stages of change (pre contemplation, contemplation, preparation, action, maintenance)
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baseline, 6 months, 12 months
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Self -Efficacy for physical activity scale
Délai: baseline, 6 months, 12 months
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range= 1-5, with higher scores representing more self-efficacy
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baseline, 6 months, 12 months
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processes of change measure
Délai: baseline, 6 months, 12 months
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range= 1-5, with higher scores representing greater use of cognitive and/or behavioral processes of change
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baseline, 6 months, 12 months
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Decisional Balance scale
Délai: baseline, 6 months, 12 months
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scores >0 indicate more advantages than disadvantages to physical activity
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baseline, 6 months, 12 months
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Dori Pekmezi, PhD, University of Alabama at Birmingham
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
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 (Estimation)
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
- X130405004
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Essais cliniques sur HIPP
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Medical University of WarsawComplété