- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03691545
Making Healthy Choices: Does Having an Online Health Coach Help?
2020년 3월 6일 업데이트: Jennifer Brunet, University of Ottawa
Helping Rural-living Young Adult Cancer Survivors Make Healthy Lifestyle Choices: Does Having a Telehealth Personal Health Coach Help?
Participating in regular physical activity and consuming a diet high in fruits and vegetables can aid in the management of various acute and chronic side effects of cancer treatment; however, few rural-dwelling young adult cancer survivors are active enough and consume enough fruits and vegetables to accrue benefits.
Telehealth interventions show promise for helping these young adults increase their motivation to participate in these behaviours by addressing barriers associated with accessing face-to-face behaviour counselling services (e.g., time commitment, travel distance).
Yet, few researchers have examined the feasibility and acceptability of a telehealth intervention that provides motivational support grounded in self-determination theory for these health behaviours in rural-dwelling young adult cancer survivors.
Based on previous research, the researchers reasoned that rural-dwelling young adult cancer survivors' physical activity and fruit and vegetable consumption would be more likely to increase if they participated in a telehealth intervention therefore, the researchers aim to test the feasibility, acceptability, and preliminary efficacy of the intervention.
The researchers also aim to assess if changes in perceived basic psychological need satisfaction, behaviour regulation, and perceived autonomy support are associated with changes in physical activity and fruit and vegetable consumption.
연구 개요
연구 유형
중재적
등록 (실제)
7
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Ontario
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Ottawa, Ontario, 캐나다, K1N6N5
- University of Ottawa
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
20년 (성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Are between the ages of 20-39 years
- Live in a rural area (i.e., areas with <35,000 inhabitants)
- Have completed primary treatment for non-metastatic cancer
- Are not currently meeting the American Cancer Society guidelines for physical activity and fruit and vegetable consumption
- Have access to the Internet and to audio-visual devices
- Are willing to provide informed consent to participate in this study and willing to follow study protocol
- Able to read and understand English
- Are ambulatory
Exclusion Criteria:
- Have a serious condition that precludes safe participation in physical activity
- Have symptomatic heart or vascular diseases (angina, peripheral vascular disease, congestive heart failure)
- Have severe hypertension
- Have had a recent stroke
- Have a chronic obstructive pulmonary disease
- Have severe insulin-dependent diabetes mellitus
- Have renal disease
- Have liver disease
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Intervention Group
(1) 12 weekly interactive sessions with a health coach to help them set goals and make changes toward becoming physically active and consuming the recommended number of fruits and vegetables.
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This arm will receive personalized health coaching (behaviour change counseling)
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Physical activity behaviour: International Physical Activity Questionnaire Short Form (IPAQ-S; Booth, 2000).
기간: Baseline (week 0) and post-intervention (week 12)
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Change in self-reported physical activity (over the past 7 days) from baseline to post-intervention, with higher scores representing a better outcome.
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Baseline (week 0) and post-intervention (week 12)
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Fruit and vegetable intake behaviour: Behavioural Risk Factor Surveillance System Fruit and Vegetable section (BRFSS-FV; Trowbridge, Wong, Byers, & Serdula, 1990)
기간: Baseline (week 0) and post-intervention (week 12)
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Change in self-reported fruit and vegetable intake (over the past 7 days) from baseline to post-intervention, with higher scores representing a better outcome.
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Baseline (week 0) and post-intervention (week 12)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Basic psychological needs satisfaction for physical activity: Psychological Need Satisfaction in Exercise Scale (PNSE; Wilson, Rogers, Rodgers, & Wild, 2006)
기간: Baseline (week 0) and post-intervention (week 12)
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Change in basic psychological need satisfaction for physical activity from baseline to post-intervention, using a 1 (false) to 6 (true) scale with higher scores representing a better outcome.
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Baseline (week 0) and post-intervention (week 12)
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Basic psychological need satisfaction for fruit and vegetable consumption: Psychological Need Satisfaction questionnaire (PNS; Deci, Ryan, Gagne, Leone, Usunov, & Kornazheva, 2001)
기간: Baseline (week 0) and post-intervention (week 12)
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Change in basic psychological need satisfaction for fruit and vegetable consumption from baseline to post-intervention, using a 1 (strongly disagree) to 7 (strongly agree) scale with higher scores representing a better outcome.
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Baseline (week 0) and post-intervention (week 12)
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Motivational regulations for physical activity: Exercise Treatment Self-Regulation Questionnaire (TSRQ-E; Williams, Deci, & Ryan, 1998)
기간: Baseline (week 0) and post-intervention (week 12)
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Change in motivational regulations for physical activity from baseline to post-intervention, using a 1 (not at all true) to 7 (very true) scale with higher scores representing a better outcome.
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Baseline (week 0) and post-intervention (week 12)
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Motivational regulations for fruit and vegetable consumption: Dietary Self-Regulation questionnaire (DSR; Williams, Deci, & Ryan, 1998)
기간: Baseline (week 0) and post-intervention (week 12)
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Change in motivational regulations for fruit and vegetable consumption from baseline to post-intervention, using a 1 (not at all true) to 7 (very true) scale with higher scores representing a better outcome.
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Baseline (week 0) and post-intervention (week 12)
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Perceived autonomy support: Health Care Climate Questionnaire (HCCQ; Williams, Grow, Freedman, Ryan, & Deci, 1996)
기간: Post-intervention (week 12)
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Level of perceived autonomy support for health behaviours post-intervention, using a 1 (strongly disagree) to 7 (strongly agree) scale with higher scores representing a better outcome.
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Post-intervention (week 12)
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Recruitment rates
기간: Duration of recruitment and intervention phase (12 weeks)
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The number of eligible participants who enrol in the study out of the number assessed for eligibility
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Duration of recruitment and intervention phase (12 weeks)
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Retention rates for intervention
기간: Duration of recruitment and intervention phase (12 weeks)
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The number of participants completing the 12-week intervention.
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Duration of recruitment and intervention phase (12 weeks)
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Adherence rates for intervention
기간: Duration of recruitment and intervention phase (12 weeks)
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The number of eligible participants completing ≥ 70% of the intervention sessions (i.e., 8/12)
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Duration of recruitment and intervention phase (12 weeks)
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Acceptability of intervention: Semi-structured interviews
기간: Post-intervention (12 weeks)
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Participants will be asked what they liked, disliked, and experienced during the intervention
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Post-intervention (12 weeks)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Williams GC, Grow VM, Freedman ZR, Ryan RM, Deci EL. Motivational predictors of weight loss and weight-loss maintenance. J Pers Soc Psychol. 1996 Jan;70(1):115-26. doi: 10.1037//0022-3514.70.1.115.
- Booth M. Assessment of physical activity: an international perspective. Res Q Exerc Sport. 2000 Jun;71(2 Suppl):S114-20. No abstract available.
- Deci, E. L., Ryan, R.M., Gagne, M., Leone, D.R., Usunov, J., & Kornazheva, B.P. (2001). Need satisfaction, motivation, and well-being in the work organizations of a former eastern bloc country: A cross-sectional study of self-determination. Journal of Personality and Social Psychology, 27(8), 930-942.
- Trowbridge FL, Wong FL, Byers TE, Serdula MK. Methodological issues in nutrition surveillance: the CDC experience. J Nutr. 1990 Nov;120 Suppl 11:1512-8. doi: 10.1093/jn/120.suppl_11.1512.
- Williams, G. C., Deci, E. L., & Ryan, R. M. (1998). Building health-care partnerships by supporting autonomy: Promoting maintained behavior change and positive health outcomes. In A. L. Suchman, P. Hinton-Walker, & R. Botelho (Ed.), Partnerships in healthcare: Transforming relational process (pp. 67-87). Rochester, NY: University of Rochester Press.
- Wilson, P. M., Rogers, W. T., Rodgers, W. M., & Wild, T. C. (2006). Psychological need satisfaction in exercise scale. Journal of Sport & Exercise Psychology, 28, 231-251.
- Price J, Brunet J. Feasibility and acceptability of a telehealth behavior change intervention for promoting physical activity and fruit and vegetable consumption among rural-living young adult cancer survivors. J Psychosoc Oncol. 2021;39(6):715-733. doi: 10.1080/07347332.2021.1896616. Epub 2021 Apr 2.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2018년 10월 1일
기본 완료 (실제)
2019년 9월 30일
연구 완료 (실제)
2019년 9월 30일
연구 등록 날짜
최초 제출
2018년 9월 27일
QC 기준을 충족하는 최초 제출
2018년 9월 28일
처음 게시됨 (실제)
2018년 10월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 3월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 3월 6일
마지막으로 확인됨
2020년 3월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- H08-18-882
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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. .
신체 활동에 대한 임상 시험
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University Hospital, Grenoble완전한관절만곡증 Amyoplasia 또는 원위 관절만곡증의 진단 | National Reference Center의 AMC Clinic에서 5일 다학제 평가 | Grenoble Alpes 병원의 Physical Medecin, Medical Genetic and Imaging 부서와 함께프랑스
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Oslo University HospitalThe Research Council of Norway완전한림프종 | 백혈병 | 암 | 줄기세포 이식
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Fundacio d'Investigacio en Atencio Primaria Jordi...완전한
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University of FloridaNational Institute on Alcohol Abuse and Alcoholism (NIAAA)모병