- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02574689
Home-based, Individually-tailored Physical Activity Print Intervention for African American Women in the Deep South (HIPP)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Alabama
-
Birmingham, Alabama, Stati Uniti, 35233
- University of Alabama at Birmingham
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 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.
|
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.
|
Comparatore attivo: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
7-Day Physical activity Recall interview (change from baseline in 7-Day physical activity recall interview)
Lasso di tempo: baseline and 6 months
|
minutes/week of moderate intensity or greater physical activity
|
baseline and 6 months
|
7-Day Physical activity Recall interview (change from baseline in 7-Day physical activity recall interview)
Lasso di tempo: baseline and 12 months
|
minutes/week of moderate intensity or greater physical activity
|
baseline and 12 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
6 minute walk test
Lasso di tempo: baseline, 6 months, 12 months
|
meters walked in 6 minutes
|
baseline, 6 months, 12 months
|
body mass index
Lasso di tempo: baseline, 6 months, 12 months
|
kg/m^2
|
baseline, 6 months, 12 months
|
waist circumference
Lasso di tempo: baseline, 6 months, 12 months
|
cm
|
baseline, 6 months, 12 months
|
body impedance analyses
Lasso di tempo: baseline, 6 months, 12 months
|
% body fat
|
baseline, 6 months, 12 months
|
Social Support for exercise scale
Lasso di tempo: baseline, 6 months, 12 months
|
range=0-65 for both friends and family subscales, with higher scores indicating more social support
|
baseline, 6 months, 12 months
|
Outcome expectations scale
Lasso di tempo: baseline, 6 months, 12 months
|
range= 1-5, with higher scores representing more outcome expectations
|
baseline, 6 months, 12 months
|
Physical Activity Enjoyment scale
Lasso di tempo: baseline, 6 months, 12 months
|
range=18-126, with higher scores indicating more enjoyment
|
baseline, 6 months, 12 months
|
accelerometers
Lasso di tempo: baseline, 6 months, 12 months
|
minutes/week of moderate intensity or greater physical activity
|
baseline, 6 months, 12 months
|
Stages of Readiness Measure
Lasso di tempo: baseline, 6 months, 12 months
|
categorize participants into stages of change (pre contemplation, contemplation, preparation, action, maintenance)
|
baseline, 6 months, 12 months
|
Self -Efficacy for physical activity scale
Lasso di tempo: baseline, 6 months, 12 months
|
range= 1-5, with higher scores representing more self-efficacy
|
baseline, 6 months, 12 months
|
processes of change measure
Lasso di tempo: baseline, 6 months, 12 months
|
range= 1-5, with higher scores representing greater use of cognitive and/or behavioral processes of change
|
baseline, 6 months, 12 months
|
Decisional Balance scale
Lasso di tempo: baseline, 6 months, 12 months
|
scores >0 indicate more advantages than disadvantages to physical activity
|
baseline, 6 months, 12 months
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Dori Pekmezi, PhD, University of Alabama at Birmingham
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- X130405004
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su HIPP
-
Medical University of WarsawCompletato