- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00962325
Increasing Physical Activity Among Inactive Bariatric Surgery Patients (Bari-Active)
Increasing Physical Activity Among Inactive Bariatric Surgery Patients
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Rhode Island
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Providence, Rhode Island, 미국, 02903
- Weight Control and Diabetes Research Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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간섭 없음: Standard care control
6 weeks of standard preoperative care
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Changes in MVPA minutes, bout-related (occurring in bouts of 10 minutes or longer) and total
기간: 6-week Post-intervention follow-up
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6-week Post-intervention follow-up
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Change in MVPA, bout-related and total
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Dale s Bond, Ph.D., The Miriam Hospital/Brown Alpert Medical School
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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