OPUS School Meal Study
2017년 3월 3일 업데이트: Arne Astrup
OPUS(Optimal Well-being, Development and Health for Danish Children Through a Healthy New Nordic Diet) School Meal Study
The aim of this randomized crossover study, is to investigate the effect of school meals based on a sustainable New Nordic Diet on growth, learning abilities, well-being, sleep quality, physical activity and risk markers of cardiovascular disease (CVD), type II diabetes and osteoporosis in 8-11 year old Danish school children.
The participating 3rd and 4th grades on 9 selected primary schools will be randomized to either start receiving New Nordic Diet school meals for 3 month(mo) or to eat their habitual school lunch for 3 mo and then crossover for additional 3 mo. All participants will be examined three times; at baseline, after 3 mo and after 6 mo.
연구 개요
연구 유형
중재적
등록 (실제)
834
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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Copenhagen, 덴마크, 1958
- Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
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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
8년 (어린이)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- Pupils in 3rd and 4th grades
- Primary Schools in the Zealand Region and Capital Region of Denmark
- Schools with an available school kitchen, that can be approved by the food authorities
- Schools where at least 60 % of the pupils in three or more classes signs up to participate in the Study
Exclusion Criteria:
- The children should not participate in a scientific study or have participated in a scientific study within the last 4 weeks. This, however depends on the character of the other study.
- The children must not suffer from serious food allergies or food intolerance.
- The children must not suffer from diseases or conditions that makes them ill-suited for participation in the study, eg. malabsorptive conditions or serious mental disorders
- The Schools must not offer an well-established common meal plan, that provides most of the pupils with healthy food on a daily basis
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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다른: NewNordicDiet first
Intervention with NND for 3 mo then no intervention for 3 mo
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The study participants are provided with three daily school meals for 3 month
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다른: NewNordicDiet last
No intervention for 3 mo and then intervention with NND for 3 mo
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The study participants are provided with three daily school meals for 3 month
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Metabolic syndrome score
기간: Change during 3 month of intervention compared with change during 3 month control period
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The metabolic syndrome score is a continuous z-score based on individual z-scores for waist circumference (WC), mean arterial pressure (MAP), serum high density lipoprotein (HDL), Serum triglyceride (TG) and Homeostasis Model Assessment (HOMA) index.
It´s an internal score meaning that the basis for the score is the distribution of values in this study population at baseline.
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Change during 3 month of intervention compared with change during 3 month control period
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Concentration Performance
기간: Change during 3 month of intervention compared with change during 3 month control period
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Concentration Performance is assessed by means of a concentration test called the D2-test of Attention.
Concentration Performance is derived from the number of correctly crossed out relevant items minus the errors of commission (confused).
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Change during 3 month of intervention compared with change during 3 month control period
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Early Cardiovascular Risk Markers
기간: Change during 3 month of intervention compared with change during 3 month control period
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Systolic and diastolic blood pressure, serum blood cholesterol (total, Low Density Lipoprotein (LDL), Very Low Density Lipoprotein (VLDL) and HDL) and TG, plasma glucose, serum insulin and the HOMA index.
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Change during 3 month of intervention compared with change during 3 month control period
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Other metabolic syndrome scores
기간: Change during 3 month of intervention compared with change during 3 month control period
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Other metabolic syndrome scores will be calculated as continuous z-scores based on each of the individual z-scores for Waist Circumference (WC), Mean Arterial Pressure (MAP), serum High Density Lipoprotein (HDL), serum Triglyceride (TG) and insulin, separately, and possibly with weighted contribution of each of the risk markers to the score.
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Change during 3 month of intervention compared with change during 3 month control period
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Inflammatory markers
기간: Change during 3 month of intervention compared with change during 3 month control period
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Plasma concentrations of the cytokines Interleucin-6 (IL-6) and Tumor Necrosis Factor (TNF) alfa, the adipokine adiponectin and the acute-phase protein c-reactive protein (CRP) (measured as high-sensitive) in plasma will be used as markers of subclinical inflammation and related to the other early metabolic syndrome and cardiovascular risk markers.
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Change during 3 month of intervention compared with change during 3 month control period
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Illnesses and use of medicine
기간: Change during 3 month of intervention compared with change during 3 month control period
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Self-reported data collected by computer-assisted questionnaire interview with the parents, either personal (month 0) or by telephone (month 3 and 6).
Outcomes are the number of days, during the last two weeks, with: asthma symptoms, use of asthma-medicine, hay-fever symptoms, use of hay-fever-medicine, atopic eczema, symptoms such as sore throat or fever, and the use of pain killers or antibiotics.
The number of days of absence from school due to illness, the number of days of illness during weekends and holidays, and number of visits to the doctor will also be evaluated.
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Change during 3 month of intervention compared with change during 3 month control period
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Use of ADHD medicine
기간: Change during 3 month of intervention compared with change during 3 month control period
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Among those children with a diagnosis of Attention Deficit/Hyperactivity Disorder (ADHD) or Attention Deficit Disorder (ADD), the mean daily dose of methylphenidate (based on reported intake of drugs containing this substance) during the last two weeks will be evaluated.
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Change during 3 month of intervention compared with change during 3 month control period
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General fatty acid composition of whole-blood
기간: Change during 3 month of intervention compared with change during 3 month control period
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Content of saturated fatty acids, monounsaturated fatty acids, polyunsaturated fatty acids, total n-3 and n-6 polyunsaturated fatty acids and the n-6:n-3 ratio in whole-blood measured as weight% relative to the weight of total fatty acids.
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Change during 3 month of intervention compared with change during 3 month control period
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Reading proficiency
기간: Change during 3 month of intervention compared with change during 3 month control period
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Reading proficiency is assessed by means of the Danish Sentence Reading test 2 having two measures: Percentage of correct sentences read within eight minutes.
Reading speed - number of sentences reached.
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Change during 3 month of intervention compared with change during 3 month control period
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Mathematics proficiency
기간: Change during 3 month of intervention compared with change during 3 month control period
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Mathematics proficiency is assessed by means of the Danish MG test for 3rd and 4th grade.
They each have one measure: Number of correct results within 45 minutes.
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Change during 3 month of intervention compared with change during 3 month control period
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Learning
기간: Change during 3 month of intervention compared with change during 3 month control period
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Student learning is assessed by means of the Danish LRS Learning Rating Scale filled out by students.
The scale contains four subscales and one combined scale (sum score) adding the four subscales.
The subscales cover: academic learning, social situation in school, teaching style appropriateness, and school expectations.
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Change during 3 month of intervention compared with change during 3 month control period
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Wellness
기간: Change during 3 month of intervention compared with change during 3 month control period
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Student wellness is assessed by means of the Danish WRS Wellness Rating Scale filled out by students.
The scale contains five subscales and one combined scale (sum score) adding the five subscales.
The subscales cover: Living environment, school, school mates, family, and self concept.
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Change during 3 month of intervention compared with change during 3 month control period
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Physical activity
기간: Change during 3 month of intervention compared with change during 3 month control period
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Physical activity is measured using actigraphy. Outcome measures will be counts/min, time spent in sedentary, light, moderate and vigorous activities. Questions regarding TV-watching, playing with videogames and physical activity, will help identify activity-pattern. |
Change during 3 month of intervention compared with change during 3 month control period
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Sleep
기간: Change during 3 month of intervention compared with change during 3 month control period
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Sleep is measured using actigraphy with the monitor placed on the right hip for all students and on the non-dominant wrist for a sub-sample. Using a sleep diary, total sleep time and sleep efficiency will be derived from these actigraphy measurements. In addition, at month 0, the abbreviated version of the Children's Sleep Habits Questionnaire (CSHQ) is used to identify sleep problems. |
Change during 3 month of intervention compared with change during 3 month control period
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Fitness
기간: Change during 3 month of intervention compared with change during 3 month control period
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Fitness is measured using the Andersen test, which is an intermittent running test to estimate maximal oxygen uptake (mL*min-1*kg-1).
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Change during 3 month of intervention compared with change during 3 month control period
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Dietary intake
기간: Change during 3 month of intervention compared with change during 3 month control period
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Dietary intake is measured as micro-and macronutrients as well as food groups (e.g.
fish and fruit/vegetables) by means of a 7-day dietary survey, which is a web based recall record method developed especially for children.
Families without internet access can use a paper version of a 7-day dietary survey.
The meal time perception is measured as well.
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Change during 3 month of intervention compared with change during 3 month control period
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Body weight and body mass index (BMI)
기간: Change during 3 month of intervention compared with change during 3 month control period
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Body weight (in kg, BMI and BMI z-score calculated on the basis of the current references from the World Health Organization (WHO)
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Change during 3 month of intervention compared with change during 3 month control period
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Body composition
기간: Change during 3 month of intervention compared with change during 3 month control period
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Body composition will be determined by Dual energy X-ray Absorptiometry (DXA) scanning.
The parameters included are total body Fat Free Mass Index (FFMI in kg/m2), total body Fat Mass Index (FMI in kg/m2), total body fat percentage and the ratio between android and gynoid fat mass in kg.
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Change during 3 month of intervention compared with change during 3 month control period
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Appetite-regulating hormones
기간: Change during 3 month of intervention compared with change during 3 month control period
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Leptin and ghrelin.
If resources are available at the end of the study period, ghrelin will be separated in acylated and deacylated ghrelin, and both the effect of the intervention on total, acylated, deacylated and the ratio between acylated:deacylated ghrelin will be assessed.
If the resources are too tight at the end of the study, only total ghrelin will be used.
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Change during 3 month of intervention compared with change during 3 month control period
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Vitamin D status
기간: Baseline and change during 3 month of intervention compared with change during 3 month control period
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Serum concentrations of 25-hydroxyvitamin D [25(OH)D] will be used as marker of vitamin D status, related to food intake and time of season.
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Baseline and change during 3 month of intervention compared with change during 3 month control period
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Bone Health
기간: Change during 3 month of intervention compared with change during 3 month control period
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Bone Health will be evaluated by DXA scanning (total body and spine Bone Mineral Content (BMC), Bone Mineral Density (BMD), and Bone Area (BA).
Osteocalcin and serum Parathyreoideahormon (PTH) are also included as markers of bone health.
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Change during 3 month of intervention compared with change during 3 month control period
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General fatty acid composition in whole-blood
기간: Change during 3 month intervnetion compared with change during 3 month control period
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Change during 3 month intervnetion compared with change during 3 month control period
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Iron status
기간: Change during 3 month intervention compared with 3 month control period
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Whole-blood hemoglobin and serum ferritin will be used as measures of iron status
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Change during 3 month intervention compared with 3 month control period
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Attention - other measures
기간: Change during 3 month of intervention compared with change during 3 month control period
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The following five measures from the attention test D2 will be used: TN=Total Number of items processed E%=Percentage of errors |
Change during 3 month of intervention compared with change during 3 month control period
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Omega-3 index in whole-blood
기간: Change during 3 month of intervention compared with change during 3 month control period
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The Omega-3 index in whole-blood is defined as the weight percentage of eicosapentaenoicacid + the weight percentage of docosahexaenoic acid in whole-blood
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Change during 3 month of intervention compared with change during 3 month control period
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Genotyping
기간: Baseline
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SNPs in genes related to metabolic pathways, messenger molecules, receptors or other genes that may affect efficacy measures in OPUS School Food Project
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Baseline
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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
- Lauritzen L, Sorensen LB, Harslof LB, Ritz C, Stark KD, Astrup A, Dyssegaard CB, Egelund N, Michaelsen KF, Damsgaard CT. Mendelian randomization shows sex-specific associations between long-chain PUFA-related genotypes and cognitive performance in Danish schoolchildren. Am J Clin Nutr. 2017 Jul;106(1):88-95. doi: 10.3945/ajcn.117.152595. Epub 2017 May 17.
- Biltoft-Jensen A, Damsgaard CT, Andersen EW, Ygil KH, Andersen R, Ege M, Christensen T, Thorsen AV, Tetens I, Wu H, Landberg R. Validation of Reported Whole-Grain Intake from a Web-Based Dietary Record against Plasma Alkylresorcinol Concentrations in 8- to 11-Year-Olds Participating in a Randomized Controlled Trial. J Nutr. 2016 Feb;146(2):377-83. doi: 10.3945/jn.115.222620. Epub 2016 Jan 13.
- Sorensen LB, Dyssegaard CB, Damsgaard CT, Petersen RA, Dalskov SM, Hjorth MF, Andersen R, Tetens I, Ritz C, Astrup A, Lauritzen L, Michaelsen KF, Egelund N. The effects of Nordic school meals on concentration and school performance in 8- to 11-year-old children in the OPUS School Meal Study: a cluster-randomised, controlled, cross-over trial. Br J Nutr. 2015 Apr 28;113(8):1280-91. doi: 10.1017/S0007114515000033. Epub 2015 Mar 20.
- Dalskov SM, Ritz C, Larnkjaer A, Damsgaard CT, Petersen RA, Sorensen LB, Ong KK, Astrup A, Molgaard C, Michaelsen KF. The role of leptin and other hormones related to bone metabolism and appetite regulation as determinants of gain in body fat and fat-free mass in 8-11-year-old children. J Clin Endocrinol Metab. 2015 Mar;100(3):1196-205. doi: 10.1210/jc.2014-3706. Epub 2014 Dec 22.
- Hjorth MF, Quist JS, Andersen R, Michaelsen KF, Tetens I, Astrup A, Chaput JP, Sjodin A. Change in sleep duration and proposed dietary risk factors for obesity in Danish school children. Pediatr Obes. 2014 Dec;9(6):e156-9. doi: 10.1111/ijpo.264. Epub 2014 Sep 24.
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
2011년 5월 1일
기본 완료 (실제)
2012년 6월 1일
연구 완료 (실제)
2012년 6월 1일
연구 등록 날짜
최초 제출
2011년 10월 20일
QC 기준을 충족하는 최초 제출
2011년 10월 20일
처음 게시됨 (추정)
2011년 10월 24일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 3월 6일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 3월 3일
마지막으로 확인됨
2017년 3월 1일
추가 정보
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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