- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00962325
Increasing Physical Activity Among Inactive Bariatric Surgery Patients (Bari-Active)
Increasing Physical Activity Among Inactive Bariatric Surgery Patients
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Rhode Island
-
Providence, Rhode Island, Forenede Stater, 02903
- Weight Control and Diabetes Research Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Activity behaviors counseling
|
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.
|
|
Ingen indgriben: Standard care control
6 weeks of standard preoperative care
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Changes in MVPA minutes, bout-related (occurring in bouts of 10 minutes or longer) and total
Tidsramme: 6-week Post-intervention follow-up
|
6-week Post-intervention follow-up
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in MVPA, bout-related and total
Tidsramme: 3- and 6-month postoperative follow-up
|
3- and 6-month postoperative follow-up
|
|
Changes in health-related quality of life
Tidsramme: 6-week Post-intervention follow-up, 3- and 6-month postoperative follow-up
|
6-week Post-intervention follow-up, 3- and 6-month postoperative follow-up
|
|
Changes in physical activity self-efficacy and outcome expectations
Tidsramme: Post-intervention follow-up, 3- and 6-month postoperative follow-up
|
Post-intervention follow-up, 3- and 6-month postoperative follow-up
|
|
Changes in physical activity enjoyment
Tidsramme: Post-intervention, 3- and 6-month postoperative follow-up
|
Post-intervention, 3- and 6-month postoperative follow-up
|
|
Weight
Tidsramme: post-intervention follow-up, 3- and 6-months postoperative
|
post-intervention follow-up, 3- and 6-months postoperative
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Dale s Bond, Ph.D., The Miriam Hospital/Brown Alpert Medical School
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- DK83438
- K01DK083438 (U.S. NIH-bevilling/kontrakt)
- DK083438-01
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