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PAthway To Health (PATH): Fostering Culturally Appropriate Physical Activities in Indigenous Communities (PATH)

2017년 6월 27일 업데이트: Linda Li, University of British Columbia

PAthway To Health (PATH): Fostering Culturally Appropriate Physical Activities Using Digital Technology in Indigenous Communities

Being physically active is important for everyone's health, but it is often challenging for people to start and sustain an activity routine. The investigators will develop and pilot test the PATH (PAthway To Health) program with Indigenous communities served by the Kwakiutl District Council (KDC) Health on North Vancouver Island. The project idea was conceived through a partnership between the communities and University of British Columbia health researchers. The PATH program will include an education sessions on how to be active, physical activity coaching by community health workers, and the use of Fitbit Flex (a wearable activity tracker). The investigators will develop a culturally appropriate online application to pair with Fitbit, which will provide instant feedback to individuals about their activity level. 60 community members will be recruited to test the PATH program. Their physical activity level, health status and use of activity resources at KDC Health Centres will be assessed.

연구 개요

상태

완전한

정황

상세 설명

Background: Promoting an active lifestyle is a priority identified by the communities served by KDC Health. Statistics Canada estimates obesity in one in four adults based on 2007-2009 data, with higher prevalence among Indigenous people compared to non-Aboriginal population (between 26% and 36% among adults living off-reserve and on-reserve, respectively). Furthermore, Indigenous people also report higher prevalence of obesity associated complications, including diabetes, cardiovascular disease, and arthritis. The association between physical inactivity and obesity suggests that increasing physical activity is important.

KDC Health offers a variety of free programs to community members, however, the use of these services has been low. KDC Health has previously partnered with the CIHR-funded IMPAKT project, and has expressed a strong interest in developing an intervention to improve health and wellness in the communities.

Objectives:

  1. To determine whether the PATH program can improve physical activity participation in the communities served by KDC Health.
  2. To assess the effect of this program on reducing sedentary time, and increasing the use of health promotion and wellness services offered by KDC Health
  3. To assess the correlation of physical activity levels and the secondary outcome measures among individuals who are living in the same household.

Methods: The investigators will conduct a community-based proof-of-concept randomized controlled trial (RCT) with 60 eligible participants. Only 1 member per household will be enrolled. If more than 1 member is interested, they will select 1 person by consensus or by a random draw.

After obtaining the baseline measures, participants will be randomly assigned to the 'Now Group' (target=30) or 'Later Group' (target=30).

The Now Group will participate in a brief education session held at the KDC Health Centre, use a wearable physical activity tracker (Fitbit Flex), and physical activity mentoring by a KDC Health Staff (the Activity Mentors). The Activity Mentors have received training for the project from the Principal Investigator. In Month 1-2, participants will meet with their Activity Mentor once every 2 weeks to review their physical activity status, activity goals, and the health programs available at the Centre. In Month 3-4, they will continue to use Fitbit Flex but will no longer have regular meetings with the Activity Mentor.

The Later Group will receive intervention two months later (i.e., Month 3-4).

The primary outcome measure will be the time spent in moderate/vigorous physical activity. In addition, time spent in sedentary behaviours will be recorded. Participants will wear a SenseWear Mini accelerometer for 7 days at baseline, 2 months, and 4 months. Secondary outcome measures include sedentary time measured with SenseWear Mini, health status that will be measured using the SF-36 (a generic measure of health-related quality of life), and body weight. Participants' use of KDC Health programs and their motivation to be physically active will also be recorded.

At the end of the program, participants will be interviewed for 30 minutes in person about their opinion on the intervention. Interviews will focus on 1) barriers/facilitators to being physically active, 2) their experience with the intervention, and 3) the nature of activities they engage in.

연구 유형

중재적

등록 (실제)

60

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • British Columbia
      • Richmond, British Columbia, 캐나다, V6X 2C7
        • Arthritis Research Canada

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

19년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

Inclusion Criteria: Participants are eligible if they:

  1. Are a person from KDC Health Member Nations
  2. Are 19 years or older
  3. Have no health condition that prevents them from being physically active
  4. Are able to participate in a 4-month project -

Exclusion Criteria: Participants are not eligible to participate if they:

  1. Do not meet the criteria above
  2. Use medication that may impair activity tolerance (e.g., beta blockers),
  3. Are unable to provide informed consent -

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 건강 서비스 연구
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Now Group - PATH Program
The Now Group will receive the PATH program. They will participate in a brief education session, use a wearable physical activity tracker, and physical activity mentoring by an Activity Mentors. In Month 1 and 2, participants will meet with their Activity Mentor once every 2 weeks to review their physical activity status, activity goals, and the health programs available at the Centre. In Month 3 and 4, they will continue to use physical activity tracker but will no longer have regular meetings with the Activity Mentor.
A brief education session, use of a wearable physical activity tracker, and physical activity mentoring by an Activity Mentor every 2 weeks.
활성 비교기: Later Group
The Later Group will receive the PATH program in Month 1-2. Intervention will be provided two months later (i.e., Month 3 and 4).
A brief education session, use of a wearable physical activity tracker, and physical activity mentoring by an Activity Mentor every 2 weeks.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Time spent in Moderate to Vigorous Physical Activity (MVPA), measured by SenseWear Mini accelerometer
기간: Change from baseline in Time spent in MVPA at 2 months and 4 months
Participants will wear a SenseWear Mini accelerometer for 7 days at baseline, and Months 2 and 4.
Change from baseline in Time spent in MVPA at 2 months and 4 months

2차 결과 측정

결과 측정
측정값 설명
기간
Time spent in sedentary behaviours, measured by SenseWear Mini accelerometer
기간: Change from baseline in time spent in sedentary behaviours at 2 months and 4 months
Participants will wear a SenseWear Mini accelerometer for 7 days at baseline, and Months 2 and 4.
Change from baseline in time spent in sedentary behaviours at 2 months and 4 months
Change in Health Status, measured by SF-36 Questionnaire
기간: Change from baseline health status at 2 months and 4 months
SF-36 Questionnaire
Change from baseline health status at 2 months and 4 months
Change in Body weight, measured by measured with a calibrated scale
기간: Change from baseline body weight at 2 months and 4 months
Measured with a calibrated scale
Change from baseline body weight at 2 months and 4 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Linda Li, PT, PhD, Arthritis Research Canada

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)

2015년 2월 1일

기본 완료 (실제)

2016년 5월 1일

연구 완료 (실제)

2016년 6월 1일

연구 등록 날짜

최초 제출

2015년 1월 5일

QC 기준을 충족하는 최초 제출

2015년 1월 12일

처음 게시됨 (추정)

2015년 1월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 6월 29일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 6월 27일

마지막으로 확인됨

2017년 6월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • H12-02526

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

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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. .

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