- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00367029
Individualized Motivational Print Materials to Encourage More Physical Activity
Achieving Physical Activity Guidelines Through an Enhanced Print Intervention
연구 개요
상세 설명
Currently, only 32% of adults in the United States participate in regular physical activity. Several healthcare organizations, including the Centers for Disease Control and Prevention, the National Institutes of Health, and the American Heart Association recommend that adults engage in a minimum of 2 ½ hours of physical activity each week. In a previous study, individuals who received motivational print materials in the mail increased their weekly physical activity more than individuals who received no motivational materials or who received motivational support over the telephone. However, about half of those who were mailed the print materials still did not reach the recommended goal of 2 ½ hours of physical activity per week. The purpose of this study is to compare the effectiveness of an enhanced version of an individualized, print-based motivational program versus a previously tested print-based motivational program at increasing physical activity levels in sedentary individuals.
This study will enroll healthy, sedentary individuals. Participants will be randomly assigned to either a print-based, individually tailored motivational program or an enhanced version of the same program. All participants will attend a baseline study visit, which will include body measurements, physical activity assessments, and health and psychological questionnaires. A select group of participants will also take part in an exercise test. Participants will then document their monthly physical activity. Study researchers will use this information, as well as the completed questionnaires, to develop individualized reports, manuals, and tip sheets that include feedback and strategies for increasing physical activity for each participant. Materials will be mailed to participants 14 times throughout the year. Participants in the enhanced intervention will receive additional materials that focus on increasing social support, self regulation, and outcome expectations, as well as materials on how to effectively monitor physical activity levels. They will also attend one study visit to assess their goals with the research staff. At Months 6 and 12, baseline evaluations will be repeated and all participants will be interviewed to assess physical activity levels.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Rhode Island
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Providence, Rhode Island, 미국, 02903
- Centers for Behavioral and Preventive Medicine, The Miriam Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- In good general health
- Sedentary
- Able to speak and read English
- Planning to live in the area for the duration of the study
Exclusion Criteria:
- Currently participates in 91 or more minutes of moderate or vigorous physical activity per week
- Heart disease
- Cerebrovascular disease
- Peripheral vascular disease
- Chronic obstructive pulmonary disease
- Diabetes
- High blood pressure
- History of gastric bypass surgery
- Psychoses
- Any serious medical problem that would make exercise unsafe or unwise
- Prior participation in a hospital-based or medically supervised weight loss program
- Excessive alcohol consumption
- Pregnant or plans to become pregnant
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: 1
Print-based, individually tailored motivational program
|
Study researchers will develop individualized reports, manuals, and tip sheets that include feedback and strategies for increasing physical activity for each participant. Materials will be mailed to participants 14 times throughout the year. Participants in the enhanced intervention will receive additional materials that focus on increasing social support, self regulation, and outcome expectations, as well as materials on how to effectively monitor physical activity levels. They will also attend one study visit to assess their goals with the research staff. |
|
실험적: 2
Enhanced version of the print-based, individually tailored motivational program
|
Study researchers will develop individualized reports, manuals, and tip sheets that include feedback and strategies for increasing physical activity for each participant. Materials will be mailed to participants 14 times throughout the year. Participants in the enhanced intervention will receive additional materials that focus on increasing social support, self regulation, and outcome expectations, as well as materials on how to effectively monitor physical activity levels. They will also attend one study visit to assess their goals with the research staff. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Achievement of 150 minutes per week of at least moderate intensity physical activity
기간: Measured by the 7-day Physical Activity Recall test at Months 6 and 12
|
Measured by the 7-day Physical Activity Recall test at Months 6 and 12
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Moderators and mediators of the intervention (e.g., motivation and enjoyment)
기간: Measured at Months 6 and 12
|
Measured at Months 6 and 12
|
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Cost-effectiveness
기간: Measured at Months 6 and 12
|
Measured at Months 6 and 12
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Bess H. Marcus, PhD, The Miriam Hospital
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
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- 408
- R01HL064342-05 (미국 NIH 보조금/계약)
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