SCALE: Small Changes and Lasting Effects (SCALE)
연구 개요
상세 설명
SCALE is a five year study (October 1, 2009 through June 30, 2014) funded by NHLBI. The study will examine the possibility and acceptance of a mindful eating intervention in African American and Latino participants. We will test whether positive thinking can protect participants against the negative impact that stress and depression can have on making positive behavior changes such as mindful eating and physical activity.
Currently, the SCALE study is in the trial phase. Among overweight or obese Black or Latino adults who live in Harlem or the South Bronx, the primary goal of this project is to achieve weight loss of 7% or more over 12 months by making small sustained changes in eating behavior coupled with sustained increases in physical activity. Participants are enrolled for 12 months and are randomized to one of two study groups.
Group 1: Will choose one of ten small change eating strategies, a physical activity goal and will receive the positive affect/self affirmation component.
Group 2: Will choose one of ten small change eating strategies and a physical activity goal
For inquiries regarding potential enrollment in this study, please contact Rosio Ramos at 646-962-5070 or email ror2023@med.cornell.edu
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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New York
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Bronx, New York, 미국, 10451
- Lincoln Medical and Mental Health Center
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Bronx, New York, 미국, 10455
- East Side House Settlement
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Bronx, New York, 미국, 10457
- Iglesia Congregacion Cristiana del Bronx
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New York, New York, 미국, 10026
- Renaissance Health Care Network
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New York, New York, 미국, 10030
- Abyssinian Baptist Church
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New York, New York, 미국, 10035
- Metropolitan Methodist Church
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Eligibility Criteria:
Black or Latino community-dwelling subjects who are 21 years or older and have a body mass index of >25 but <50 or considered to be obese or overweight are be eligible for study participation. All participants must be able to participate in physical activity and Must be fluent in English or Spanish.
Exclusion Criteria:
Subjects will be excluded if:
- Unable to provide informed consent in either English or Spanish for any reason, including cognitive impairment, psychiatric illness, drug or alcohol addiction
- Pregnant or are planning to become pregnant within the year
- Participating in another weight loss program or trial
- On medications for obesity
- Have a history of bulimia;
- history of surgery for obesity;
- Have severe comorbid diseases that can lead to unintentional weight change including cancer, HIV/AIDS, congestive heart failure.
- They live in an institutional setting (nursing home, prison or group home).
Have severe disease or are terminally ill, including stroke, myocardial infarction, coronary artery disease requiring angioplasty.
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공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Group 1
Subjects in will be randomized to the small change eating strategy, a physical activity goal and will receive the positive affect/self affirmation component. eating/physical activity/positive affect/self-affirmation group. |
Subjects will be randomized to the small change eating strategy, a physical activity goal and will receive the positive affect/self affirmation component.
다른 이름들:
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실험적: Group 2
Subjects will be randomized to the small change eating strategy and a physical activity goal. eating/physical activity group. No intervention, just the eating strategy and physical activity components. |
Subjects will be randomized to the small change eating strategy and a physical activity goal.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percent weight loss
기간: 12 months
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The primary goal of this project is to achieve weight loss of 7% or more over 12 months by making small sustained changes in eating behavior coupled with sustained increases in physical activity.
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12 months
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공동 작업자 및 조사자
간행물 및 유용한 링크
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .