MEST : A School- Based Health Literacy Intervention Trial
A Cluster- Randomized Controlled Trial Evaluating the MEST Work Strategy to Improve Health Literacy Among Upper Secondary School Students
The purpose of this study is to evaluate the effectiveness of the MEST work strategy in upper secondary schools. MEST is a school based, health promoting intervention delivered by school health services and designed to strengthen students' health literacy and mental well being. The study assesses whether implementation of the MEST work strategy results in improved health literacy and mental well being compared with usual school health services.
This study is a cluster randomized superiority trial in which upper secondary schools are assigned either to an intervention group implementing the MEST work strategy or to a control group continuing with school health services as usual. Student reported outcomes are collected using digitally administered questionnaires during school hours at baseline, prior to initiation of the intervention, and at 4 and 9 months following intervention initiation (end of the school year).
연구 개요
상세 설명
This study is a cluster randomized controlled trial conducted in upper secondary schools, with schools serving as the unit of randomization to minimize contamination between students. A matched pair allocation design is used to ensure balance between trial arms. The anticipated enrollment is 12 schools (clusters).
Simulation based power analyses indicated that the primary analytic models yielded approximately 0.62-0.72 power to detect an effect size of d = 0.30 and were generally close to or exceeded 0.80 when the post test effect size was larger (d = 0.40).
The MEST work strategy is implemented during regular school hours by school health services and is designed to enhance students' ability to access, understand, evaluate, and apply health related information, with a specific focus on health literacy and mental well being. Data are collected using digitally administered questionnaires at baseline (T0), 4 months (T1), and 9 months (T2) following initiation of the intervention.
The primary outcome is general health literacy. Secondary outcomes include mental health literacy and mental well being. Prespecified secondary subgroup/moderator analyses will examine potential effect modification by gender, socioeconomic status, and minority, Indigenous, or immigrant background. Additional exploratory analyses will assess whether the dose of the MEST work strategy delivered is associated with outcomes. Outcome data are reported by students, while information on intervention dose is obtained from the school health services.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Hanne N Bjørnsen, RN, MS, MPH, PhD
- 전화번호: 004790107526
- 이메일: hanne.nissen.bjornsen@fhi.no
연구 연락처 백업
- 이름: Hilde E Toreid, RN, MS
- 전화번호: 004790874102
- 이메일: hilde.elisabeth.toreid@fhi.no
연구 장소
-
-
Trøndelag
-
Levanger, Trøndelag, 노르웨이, 7600
- Norwegian Institute of Public Health (NIPH)
-
연락하다:
- Hilde E Toreid, RN, MS
- 전화번호: 004790874102
- 이메일: hilde.elisabeth.toreid@fhi.no
-
연락하다:
- Boye Welde, Dr.Philos
- 전화번호: 004799357696
- 이메일: boye.welde@fhi.no
-
수석 연구원:
- Hilde E Toreid, RN, MS
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Students 16-24 years
- Students enrolled in upper secondary school classes
- Provided informed consent
Exclusion Criteria:
- Students <16 years and > 24 years
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: MEST Work Strategy
Schools assigned to the intervention arm receive the MEST work strategy delivered by school health services during regular school hours over one school year.
The intervention is designed to strengthen students' general health literacy through structured learning activities, facilitated discussions, and individual follow up when needed.
|
The MEST work strategy is needs based and adaptive.
An anonymous, digitally administered MEST survey conducted prior to intervention initiation informs the selection and tailoring of intervention topics throughout the school year.
This survey is used solely to guide intervention delivery and is not included in the outcome evaluation.
Intervention activities may include classroom based sessions, school wide seminars, small thematic group activities, and individual consultations provided by the school health services, depending on identified student needs.
All activities are conducted on school premises using existing school facilities and digital infrastructure.
|
|
간섭 없음: Control- School Health Servics as usual
Schools assigned to the control arm continue with school health services as usual throughout the study period.
Usual care includes routine health promotion activities and access to individual consultations provided within the existing school health services.
Schools in the control arm are not exposed to the MEST work strategy during the study period.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
General Health Literacy
기간: Baseline, 4 months, 9 months
|
General health literacy assessed using the Health Literacy Survey 2019 - Young Persons 12-item scale (HLS19 YP12). The instrument consists of 12 items, each rated on a 4 point scale. Total scores range from 12 to 48, with higher scores indicating higher (better) levels of health literacy. |
Baseline, 4 months, 9 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Mental Health Literacy
기간: Baseline, 4 months, 9 months
|
Mental health literacy using the Mental Health Learning Scale (MHLS-9).
The instrument consists of 9 items, each rated on a 5- point likert scale, giving a total score from 9 to 45, with higher scores indicating higher (better) levels of mental health literacy.
|
Baseline, 4 months, 9 months
|
|
Mental Well-Being
기간: Baseline, 4 months, 9 months
|
Mental well-being assessed using the Short Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS).
The instrument consist of 7 items, each rated on a 5- point scale.
It ranges from 7 to 35 points, with higher scores indicating better mental well- being.
|
Baseline, 4 months, 9 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Hanne N Bjørnsen, RN, MS, MPH, PhD, Norwegian Institute of Public Health
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- SDAM_FOR555624 /NIPH 6107-6107
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .