Shift Workers' Health Behavior Action Program Across Europe (SHAPE)
2026년 8월 18일 업데이트: Marco Mensink, Wageningen University
This study evaluates the effects of a Combined Lifestyle Intervention Program (CLIP) on sleep, lifestyle behaviors, obesity risk and health in night-shift workers.
The primary objective is to assess the effect of the CLIP on objectively measured sleep duration.
Secondary objectives include behavioral outcomes related to sleep, diet, physical activity, and stress, as well as body weight and metabolic outcomes, .
It is hypothesized that CLIP participants will show a greater increase in sleep duration than controls, alongside favorable changes in lifestyle and health outcomes.
연구 개요
연구 유형
중재적
등록 (추정된)
400
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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Rotterdam, 네덜란드
- 모병
- Erasmus Medical Centre
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연락하다:
- H. Lammers-van der Holst
- 전화번호: 0031 10 704 0704
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Wageningen, 네덜란드
- 모병
- Wageningen University & Research
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연락하다:
- M. Mensink
- 전화번호: 0031 (0)317 480 100
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Bremen, 독일
- 모병
- Uni Bremen
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연락하다:
- U. Klink
- 전화번호: 0049 421 218 68980
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Bremerhaven, 독일
- 아직 모집하지 않음
- TTZ
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Lodz, 폴란드
- 아직 모집하지 않음
- Lodz
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연락하다:
- M. Wrzesińska
- 전화번호: 0048 42 272 58 13
- 이메일: prorektor.int@umed.lodz.pl
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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
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
Inclusion Criteria:
- Age ≥ 21 years
- Work ≥ 24 hours per week
- Shift work duration > 3 years and currently doing night shifts
- Expected to continue night shiftwork for at least 1 year after inclusion
- On average working ≥ 4 night shifts per month
- Working generally ≥ 2 consecutive night shifts
- In possession of a smartphone and willing to download the study application
Exclusion Criteria:
- Body Mass Index (BMI) < 18.5 or > 40 kg/m2
- Pregnant or lactating
- Chronic diseases with ongoing therapy (e.g. renal failure, active hepatitis, cirrhosis, myocardial infarction, chronic obstructive pulmonary disease and cancer)
- Current or recent use of medications interfering with sleep, including: Central nervous system stimulants (e.g., Ritalin, Adderall, Modafinil or similar); Chronic use of sleep agents (e.g., benzodiazepine, non-hypnotic benzodiaze-pine, first-generation antihistamine, melatonin receptors agonists or similar); Other medications or combinations significantly affecting sleeping patterns
- Recent or ongoing psychotherapy for sleep disorders
- Current or recent use of medications affecting appetite or weight regulation, including: Appetite-enhancing/weight-gain medications (e.g., atypical antipsychotics, cor-ticosteroids such as prednisone, mirtazapine or similar); Appetite-suppressing/weight-loss medications (e.g., CNS stimulants such as Ritalin, Adderall, GLP-1 receptors agonists or similar); Other medications or combinations significantly influencing appetite or body weight
- Participation in another human trial, lifestyle program or weight loss intervention within the past 3 months
- Planned surgical procedure during the study period
- History of or planned bariatric surgery/treatment
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Intervention
Intervention group receives access to the 24-week combined lifestyle intrevention, which includes the mobile intervention app and four interactive workshops.
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The 24-week lifestyle intervention is structured in four 6-week blocks focusing on sleep and stress management or diet and physical activity.
Lifestyle advice and behavior change techniques are delivered via a mobile application, complemented by workshops.
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간섭 없음: Control
The control group receives informational brochures with general advice on the four life-style domains, without active behavioral support.
The control group receives access to the combined lifestyle intrevention after the intervention period has ended.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Sleep duration
기간: From enrollment to the end of intervention (24 weeks)
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Total sleep time (min/24h)
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From enrollment to the end of intervention (24 weeks)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Body weight
기간: From enrollment to end of intervention (24 weeks)
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(kg)
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From enrollment to end of intervention (24 weeks)
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BMI
기간: From enrollment to end of intervention (24 weeks)
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(kg/m2)
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From enrollment to end of intervention (24 weeks)
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Objective sleep quality
기간: From enrollment to end of intervention (24 weeks)
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Wake after sleep onset (min spent awake/main sleep episode), derived from actigraphy data
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From enrollment to end of intervention (24 weeks)
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Overall diet quality
기간: From enrollment to end of intervention (24 weeks)
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Diet quality score: Eetscore™, a 55-item FFQ which is scored with the Dutch Healthy Diet 2015-index to evaluate adherence to the Dutch food-based dietary guideline; resulting in a total score between zero (no adherence) and 100 (complete adherence).
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From enrollment to end of intervention (24 weeks)
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Physical activity level
기간: From enrollment to end of intervention (24 weeks)
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Light, moderate, vigorous activity (min), Sedentary time (min) as measured with an actigraphy (Motionwatch)
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From enrollment to end of intervention (24 weeks)
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Perceived stress
기간: From enrollment to end of intervention (24 weeks)
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Perceived stress score (PSS-10), a 10-item validated questionnaire assessing the extent to which individuals perceive their lives as unpredictable, uncontrollable, and overloaded.
Items are rated on a 5-point Likert scale referring to experiences over the past month; higher score mean more stress.
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From enrollment to end of intervention (24 weeks)
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Subjective sleep quality (Insomina)
기간: From enrollment to end of intervention (24 weeks)
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Insomnia severity (0-28): a 7-item self-administered questionnaire validated in shift workers as a proxy for sleep quality.
Items assess the severity of insomnia symptoms, including difficulties with sleep onset, maintenance, and early awakening.
Each item is scored 0-4, with total scores ranging from 0 to 28; higher scores indicate more severe insomnia
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From enrollment to end of intervention (24 weeks)
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Subjective leep quality (pattern)
기간: [Time Frame: From enrollment to end of intervention (24 weeks)]
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Shift Work Disorder Questionnaire (SWDQ): a 4-item questionnaire assessing sleep patterns, excessive sleepiness, and functional impairment related to shift work (53).
Each item is scored 1-4, yielding a total score of 4-16, with higher scores reflecting greater symptom severit
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[Time Frame: From enrollment to end of intervention (24 weeks)]
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Chrono-nutrition patterns
기간: From enrollment to end of intervention (24 weeks)
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Meal timing, frequency, regularity; using the Chrono nutrition Questionnaire for Shift Workers (CNQ-Shift).
The questionnaire contains 20-23 questions, five questions each for morning, afternoon, and night shifts, three split shifts questions (if applicable), and two questions for work-free days.
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From enrollment to end of intervention (24 weeks)
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Food preferences
기간: From enrollment to end of intervention (24 weeks)
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FFPQ (liking/wanting scores): Participants rate "how pleasant it would be to try a bite of this food," using a 100-point visual analogue scale (explicit liking).
A forced choice procedure is then carried used to assess which food participants would "most like to eat now" (implicit wanting).
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From enrollment to end of intervention (24 weeks)
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Occupational physical activity
기간: From enrollment to end of intervention (24 weeks)
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OSPAQ (min)
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From enrollment to end of intervention (24 weeks)
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Work-related sense of coherence
기간: From enrollment to end of intervention (24 weeks)
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Work-related sense of coherence Work-Soc (5-point Likert scale), a 9-scale assessing individuals' perceived comprehensibility, manageability, and meaningfulness at work.
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From enrollment to end of intervention (24 weeks)
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Satisfaction With Life
기간: [Time Frame: From enrollment to end of intervention (24 weeks)]
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Satisfaction With Life Scale (SWLS): a 5-item questionnaire evaluating global life satisfaction (66).
Items are rated on a 7-point scale
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[Time Frame: From enrollment to end of intervention (24 weeks)]
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Body composition
기간: From enrollment to end of intervention (24 weeks)
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body Fat percentage (%) measured with bio-impedance analysis (BIA)
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From enrollment to end of intervention (24 weeks)
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waist to hip circumference
기간: [Time Frame: From enrollment to end of intervention (24 weeks)]
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ratio of waist and hip circumference (cm/cm)
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[Time Frame: From enrollment to end of intervention (24 weeks)]
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Behavior assessment
기간: From enrollment to end of intervention (24 weeks)
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Action planning, Coping planning, Habit formation, Intention.
All items are scored on a either a 5 or 7-point Likert scale ranging from totally disagree to totally agree.
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From enrollment to end of intervention (24 weeks)
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Stress biomarker
기간: From enrollment to end of intervention (24 weeks)
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Hair cortisol concentraition (HCC), pg/mg hair
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From enrollment to end of intervention (24 weeks)
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glucose
기간: [Time Frame: From enrollment to end of intervention (24 weeks)]
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fasted blood glucose (mM)
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[Time Frame: From enrollment to end of intervention (24 weeks)]
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Insulin
기간: [Time Frame: From enrollment to end of intervention (24 weeks)]
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fasted plasma insulin (pmol/L)
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[Time Frame: From enrollment to end of intervention (24 weeks)]
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blood lipids
기간: [Time Frame: From enrollment to end of intervention (24 weeks)]
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fasted blood lipids (mmol/L)
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[Time Frame: From enrollment to end of intervention (24 weeks)]
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blood pressure
기간: [Time Frame: From enrollment to end of intervention (24 weeks)]
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Diastolic and systolic blood pressure in fasted state (mmHg)
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[Time Frame: From enrollment to end of intervention (24 weeks)]
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circadian biomarker
기간: [Time Frame: From enrollment to end of intervention (24 weeks)]
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urinary melatonin (ng/mL)
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[Time Frame: From enrollment to end of intervention (24 weeks)]
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Participant satisfaction and feasibility
기간: end of intervention (week 24)
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assessed using a study-specific questionnaire evaluating participants' experiences with the intervention content, delivery, usability, and perceived burden of the intervention
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end of intervention (week 24)
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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.
유용한 링크
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)
2026년 5월 15일
기본 완료 (추정된)
2027년 7월 1일
연구 완료 (추정된)
2027년 12월 1일
연구 등록 날짜
최초 제출
2026년 5월 1일
QC 기준을 충족하는 최초 제출
2026년 6월 1일
처음 게시됨 (실제)
2026년 6월 8일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 20일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 18일
마지막으로 확인됨
2026년 5월 1일
추가 정보
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