- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00962325
Increasing Physical Activity Among Inactive Bariatric Surgery Patients (Bari-Active)
Increasing Physical Activity Among Inactive Bariatric Surgery Patients
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
The proportion of Americans who are severly obese or more than 100 pounds overweight is rapidly increasing. This presents a significant public health challenge as severely obese individuals have a higher rate of comorbidities and exact a greater toll on the health care system than less obese persons. For these individuals, bariatric surgery is currently the treatment of choice for producing substantial and long-term weight loss, although outcomes vary. Low physical activity is one behavioral factor that undermines surgical success. However, structured behavioral interventions to increase physical activity in bariatric surgery patients have not been conducted.
This study involves a randomized controlled trial that compares the effects of a behavioral intervention to increase physical activity with a standard care control group on changes in physical activity among adult bariatric surgery patients with low physical activity. Eighty bariatric surgery patients will be assigned to 6 weeks of either preoperative: (1) intervention to increase physical activity or (2) standard care control. Participants in the intervention group will receive individual, face-to-face sessions involving tailored instruction in use of standard behavior change strategies such as self-monitoring, goal setting and stimulus control. The PA intervention will focus on increasing home-based walking exercise. Physical activity will be objectively measured for 7 consecutive days via accelerometry at baseline/pre-intervention, post-intervention, and 3- and 6-months postoperative follow-up. At each time point, the groups will be compared on total moderate-to-vigorous physical activity (MVPA) minutes and MVPA minutes occurring in bouts of 10 minutes or longer. This study will test whether the behavioral physical activity intervention produces greater increases in pre- and post-operative physical activity than standard care. The long-term goal of this research is to improve bariatric surgery outcomes through innovative behavioral strategies to increase physical activity.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Rhode Island
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Providence, Rhode Island, Spojené státy, 02903
- Weight Control and Diabetes Research Center
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- BMI equal to or greater than 40 or greater than or equal to 35 (in presence of significant comorbidities)
- Have elected to undergo Roux-en-Y gastric bypass or laparoscopic adjustable gastric banding
- Able to engage in activities of daily living
- Currently inactive, defined as less than 150 weekly minutes of moderate-to-vigorous physical activity in bouts of 10 minutes or more
- Obtainment of written consent from surgeon to participate
Exclusion Criteria:
- Unable to engage in activities of daily living
- Report conditions that would render the participant unlikely to follow the study protocol (e.g., relocation, substance abuse, severe psychiatric condition)
- Inability to understand program instructions due to language barrier or a mental disability
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Activity behaviors counseling
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This will be a 6-week preoperative intervention to increase structured walking activity.
This will be accomplished through weekly individual face-to-face sessions involving tailored instruction in use of standard behavior change strategies such as self-monitoring, goal-setting, stimulus control, etc.
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Žádný zásah: Standard care control
6 weeks of standard preoperative care
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
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Changes in MVPA minutes, bout-related (occurring in bouts of 10 minutes or longer) and total
Časové okno: 6-week Post-intervention follow-up
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6-week Post-intervention follow-up
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
Change in MVPA, bout-related and total
Časové okno: 3- and 6-month postoperative follow-up
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3- and 6-month postoperative follow-up
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Changes in health-related quality of life
Časové okno: 6-week Post-intervention follow-up, 3- and 6-month postoperative follow-up
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6-week Post-intervention follow-up, 3- and 6-month postoperative follow-up
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Changes in physical activity self-efficacy and outcome expectations
Časové okno: Post-intervention follow-up, 3- and 6-month postoperative follow-up
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Post-intervention follow-up, 3- and 6-month postoperative follow-up
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Changes in physical activity enjoyment
Časové okno: Post-intervention, 3- and 6-month postoperative follow-up
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Post-intervention, 3- and 6-month postoperative follow-up
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Weight
Časové okno: post-intervention follow-up, 3- and 6-months postoperative
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post-intervention follow-up, 3- and 6-months postoperative
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Dale s Bond, Ph.D., The Miriam Hospital/Brown Alpert Medical School
Publikace a užitečné odkazy
Obecné publikace
- Bond DS, Raynor HA, Thomas JG, Unick J, Webster J, Ryder B, Vithiananthan S. Greater Adherence to Recommended Morning Physical Activity is Associated With Greater Total Intervention-Related Physical Activity Changes in Bariatric Surgery Patients. J Phys Act Health. 2017 Jun;14(6):492-498. doi: 10.1123/jpah.2016-0529. Epub 2017 Mar 2.
- Bond DS, Vithiananthan S, Thomas JG, Trautvetter J, Unick JL, Jakicic JM, Pohl D, Ryder BA, Roye GD, Sax HC, Wing RR. Bari-Active: a randomized controlled trial of a preoperative intervention to increase physical activity in bariatric surgery patients. Surg Obes Relat Dis. 2015 Jan-Feb;11(1):169-77. doi: 10.1016/j.soard.2014.07.010. Epub 2014 Jul 30.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- DK83438
- K01DK083438 (Grant/smlouva NIH USA)
- DK083438-01
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Klinické studie na Intervention to increase physical activity
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University of Alabama at BirminghamCenters for Disease Control and PreventionNáborRodinné vztahy | PlíseňSpojené státy