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Increasing Physical Activity Among Inactive Bariatric Surgery Patients (Bari-Active)

14. marts 2016 opdateret af: Dale Bond, The Miriam Hospital

Increasing Physical Activity Among Inactive Bariatric Surgery Patients

For the growing number of severely obese individuals, there are currently few effective long-term weight control options with the exception of bariatric surgery. However, behavioral factors including low physical activity can undermine successful surgical outcomes. This study will compare the effects of a behavioral physical activity intervention with a standard care control condition on changes in physical activity among inactive adult bariatric surgery patients.

Studieoversigt

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

Interventionel

Tilmelding (Faktiske)

80

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02903
        • Weight Control and Diabetes Research Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

21 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Dale s Bond, Ph.D., The Miriam Hospital/Brown Alpert Medical School

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2009

Primær færdiggørelse (Faktiske)

1. april 2014

Studieafslutning (Faktiske)

1. juni 2015

Datoer for studieregistrering

Først indsendt

19. august 2009

Først indsendt, der opfyldte QC-kriterier

19. august 2009

Først opslået (Skøn)

20. august 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. marts 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. marts 2016

Sidst verificeret

1. marts 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DK83438
  • K01DK083438 (U.S. NIH-bevilling/kontrakt)
  • DK083438-01

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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