- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02729675
Innovative Approaches to Increase F&V Intake Thru Worksites (Good to Go)
Innovative Approaches to Increase F&V Intake Thru Worksites: The Fresh Initiative
연구 개요
상태
상세 설명
"Good to Go" (GTG) is a cluster randomized trial, which is studying the efficacy of innovative multi-level worksite interventions including educational/behavioral interventions and/or a fruit and vegetable (F&V) market at the worksite to improve F&V intake of employees. The hypothesis is that providing convenient, inexpensive access to F&V at the workplace through a F&V market will increase the availability of F&V at the workplace as well as at home and increase F&V intake of the employee. However, because it is unclear if improving F&V access and availability alone is adequate to increase F&V intake, the investigators will test the efficacy of the F&V delivery intervention alone and in combination with a promotional/educational intervention delivered at the worksite. The efficacy of these innovative interventions will be tested during a cluster randomized trial with 21 worksites to determine which interventions are most efficacious in increasing F&V consumption.
The primary specific aims of this proposed research are to employ a cluster randomized trial to study the efficacy of delivering fresh F&V at reduced prices for purchase at worksites (access intervention); the F&V delivery intervention paired with educational interventions to change informational and social environments at the worksite (enhanced intervention); and a comparison intervention acting as an attention placebo. The study will compare the efficacy of the Access intervention and the enhanced intervention with the comparison Arm and will also compare the efficacy of the Access intervention to the Enhanced intervention.
연구 유형
등록 (실제)
단계
- 2 단계
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- works at least 25 hours per week at the worksite
- is on-site at least half of every day shift during the week
- reads and understands English.
Exclusion Criteria:
- has a medical condition that would prevent consumption of most fruits and vegetables,
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Access Intervention
Worksites in this condition received weekly Fruit and Vegetable markets
|
The 7 worksites in this arm received year-round, weekly mobile F&V markets (Fresh To You - FTY) selling local and non-local fresh produce at or below local supermarket prices.
The markets carried 50 to 70 different produce items and were held both indoors and outdoors depending on the weather and worksite preference.
When held indoors, F&V were sold in a cafeteria or other highly trafficked area.
In good weather, the markets were held outside on the worksite property in a retrofitted a car trailer.
Each market lasted two hours.
On average, FTY prices were 15% to 25% lower than local retail supermarket prices.
Signs, posters, email blasts and flyers advertised the markets.
The FTY intervention at each worksite began with a Kick-Off event, which included the first FTY market.
Each employee who attended the first market received a large, reusable shopping bag with the FTY logo on it and a freezer pack to keep F&V fresh.
다른 이름들:
|
|
실험적: Enhanced Intervention
Worksites in this condition received weekly Fruit and Vegetable markets and Educational Interventions including Campaigns, Newsletters, DVDs, A Website, and Chef Demonstrations
|
The 7 worksites in this arm received year-round, weekly mobile F&V markets (Fresh To You - FTY) selling local and non-local fresh produce at or below local supermarket prices.
The markets carried 50 to 70 different produce items and were held both indoors and outdoors depending on the weather and worksite preference.
When held indoors, F&V were sold in a cafeteria or other highly trafficked area.
In good weather, the markets were held outside on the worksite property in a retrofitted a car trailer.
Each market lasted two hours.
On average, FTY prices were 15% to 25% lower than local retail supermarket prices.
Signs, posters, email blasts and flyers advertised the markets.
The FTY intervention at each worksite began with a Kick-Off event, which included the first FTY market.
Each employee who attended the first market received a large, reusable shopping bag with the FTY logo on it and a freezer pack to keep F&V fresh.
다른 이름들:
The 7 worksites in this arm received the Access intervention described above as well as set of educational/behavioral interventions.
At the Kick-Off, employees received the first month's newsletter and an educational digital video disk (DVD) in the reusable shopping bag.
They also received a chef-run cooking demonstration/taste-testing along with recipes and information about the upcoming intervention activities.
Intervention activities included two 6-week campaigns (Just Add Two and Choose Color, Choose Health); a 90 minute DVD with cooking demonstrations about preparing quick, healthy inexpensive meals and unusual F&V; a two-page, full-color newsletter distributed monthly; Food demonstrations/tastings delivered once a month by chefs including an easy to prepare, F&V-based recipe; a total of 12 recipe handouts that correlated with the monthly cooking demonstration; a Good to Go website; and a project bulletin board.
다른 이름들:
|
|
활성 비교기: Comparison Intervention
Worksites in this condition received Stress and Physical Activity Interventions
|
Brown University contracted with the Greater Providence Young Men's Christian Association (YMCA) to provide a physical activity and stress reduction intervention at the 7 worksites in the comparison group.
Two, six-week campaigns were developed jointly by the Brown study team and YMCA staff.
These campaigns followed the same format as the enhanced intervention group campaigns and were provided during the same time periods as those at the enhanced intervention sites.
Everyone who participated in the campaigns also received a free, 6-week membership to the YMCA.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Fruit and Vegetable Intake
기간: Baseline, 6 and 12 months
|
Measured by National Cancer Institute Eating at America's Table All Day Screener
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Baseline, 6 and 12 months
|
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Change in Fruit and Vegetable Intake
기간: Baseline, 6 and 12 months
|
Two-Item Cup F&V intake screener
|
Baseline, 6 and 12 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in fruit and vegetable eating behaviors
기간: Baseline, 6 and 12 months
|
F&V habits questions
|
Baseline, 6 and 12 months
|
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 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- R01CA133396 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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. .
식습관에 대한 임상 시험
-
Western University, Canada아직 모집하지 않음
-
University of Haifa완전한산후 기간 | 산모 정신 건강 | Parenting / Maternal Behavior | 초산 (첫 아이를 임신한 산모) | 산후 우울 증상이스라엘
Access Intervention에 대한 임상 시험
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Beckman Coulter, Inc.완전한
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Hugo W. Moser Research Institute at Kennedy Krieger...완전한
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Memorial Sloan Kettering Cancer Center모병
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Lawson Health Research InstituteBoston Scientific Corporation종료됨
-
Shanghai Yueyang Integrated Medicine Hospital아직 모집하지 않음
-
Second Affiliated Hospital, School of Medicine,...모집하지 않고 적극적으로
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Hospices Civils de Lyon아직 모집하지 않음
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University of North Carolina, GreensboroInstitute of Education Sciences완전한주의 결핍 과잉 행동 장애