- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT00814554
Effectiveness Evaluation of Three Strategies of Promotion of Healthy Dietary and Physical Activity Behaviours to Prevent Weight Excess Among Teenagers (PRALIMAP)
29 июня 2010 г. обновлено: University of Nancy
PRALIMAP: Effectiveness Evaluation of Three Strategies of Prevention of Overweight and Obesity in Adolescents; a Cluster Randomised Controlled Trial
The aim of this study is to compare the effectiveness of three public health intervention strategies to reduce weight excess and obesity prevalence among teenagers within the frame of a public health program aiming at promoting healthy eating and physical activity behaviors.
Обзор исследования
Статус
Завершенный
Условия
Подробное описание
A cluster randomised trial implemented in 24 high and technical schools including 20 000 fifth-former aims, on a three-year period, at evaluating the effectiveness of three strategies, combined or not, according a 2*2*2 factorial plan, concerning the promotion of healthy dietary and physical activity behaviours: to develop individual skills by individual and collective education, to propose favourable environment, to screen and care for subjects at risk of weight excess.
Main outcomes are improvement of knowledge, attitudes and behaviours, mean body mass index (BMI) change, proportion of obese children according to international standards after two years of follow-up, and finally psychological and sociological factors which are facilitators or barriers to such actions.
The evidence of the effectiveness of one or the other of the strategies will help to define interventions framework for medical, educative and economic sector actors.
Тип исследования
Интервенционный
Регистрация (Действительный)
5458
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Vandoeuvre les nancy, Франция, 54500
- Nancy-University
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
Inclusion Criteria:
- Being student in the included public high school in Region of Lorraine (East of France) whatever the age
Exclusion Criteria:
- None
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Факторное присвоение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Без вмешательства: control
no intervention was carried out in high school
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Экспериментальный: Educational strategy
Educational strategy was carried out in high school.
|
1.Educational strategy.
The strategy is to implement health promotion actions aiming at developing personal skills to adopt healthy behaviors in the field of nutrition and physical activity in conformity with up-to-date recommendations and references.
Each adolescent will be provided with about 50 education hours distributed in individual and collective activities in school (15 hours), interventions during courses (20 hours), and outdoors activities (15 hours).
Другие имена:
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Экспериментальный: Screening strategy
Screening strategy was carried out in high school.
|
2. Screening strategy.
Screening includes measurement of BMI and plotting the growing chart with adolescents, measurement of eating troubles.
Screening will be performed by the school medical and nurse team.
At risk subjects will be defined according to precise criteria and will be referred to the GP and to obesity networks developed by Health Insurance system where they are provided with specific activities with dieticians, physical activity teachers and psychologists.
Subjects with psychological difficulties will be referred for psychological care.
Другие имена:
|
|
Экспериментальный: Environmental strategy
Environmental strategy was carried out in high school.
|
3. Environmental strategy.
The strategy is to develop in schools favorable and supportive environments for healthy behaviors targeting the collective catering and physical activity offer and the establishment policy.
Especially actions aim at increase fruits and vegetables availability, water consumption, physical activity inside the schools.
Другие имена:
|
|
Экспериментальный: Educational and Screening strategies
Educational strategy and Screening strategy were carried out in high school
|
1.Educational strategy.
The strategy is to implement health promotion actions aiming at developing personal skills to adopt healthy behaviors in the field of nutrition and physical activity in conformity with up-to-date recommendations and references.
Each adolescent will be provided with about 50 education hours distributed in individual and collective activities in school (15 hours), interventions during courses (20 hours), and outdoors activities (15 hours).
Другие имена:
2. Screening strategy.
Screening includes measurement of BMI and plotting the growing chart with adolescents, measurement of eating troubles.
Screening will be performed by the school medical and nurse team.
At risk subjects will be defined according to precise criteria and will be referred to the GP and to obesity networks developed by Health Insurance system where they are provided with specific activities with dieticians, physical activity teachers and psychologists.
Subjects with psychological difficulties will be referred for psychological care.
Другие имена:
|
|
Экспериментальный: Screening and Environmental strategies
Screening strategy and Environmental strategy were carried out in high school
|
2. Screening strategy.
Screening includes measurement of BMI and plotting the growing chart with adolescents, measurement of eating troubles.
Screening will be performed by the school medical and nurse team.
At risk subjects will be defined according to precise criteria and will be referred to the GP and to obesity networks developed by Health Insurance system where they are provided with specific activities with dieticians, physical activity teachers and psychologists.
Subjects with psychological difficulties will be referred for psychological care.
Другие имена:
3. Environmental strategy.
The strategy is to develop in schools favorable and supportive environments for healthy behaviors targeting the collective catering and physical activity offer and the establishment policy.
Especially actions aim at increase fruits and vegetables availability, water consumption, physical activity inside the schools.
Другие имена:
|
|
Экспериментальный: Educational and Environmental strategies
Educational strategy and Environmental strategy were carried out in high school
|
1.Educational strategy.
The strategy is to implement health promotion actions aiming at developing personal skills to adopt healthy behaviors in the field of nutrition and physical activity in conformity with up-to-date recommendations and references.
Each adolescent will be provided with about 50 education hours distributed in individual and collective activities in school (15 hours), interventions during courses (20 hours), and outdoors activities (15 hours).
Другие имена:
3. Environmental strategy.
The strategy is to develop in schools favorable and supportive environments for healthy behaviors targeting the collective catering and physical activity offer and the establishment policy.
Especially actions aim at increase fruits and vegetables availability, water consumption, physical activity inside the schools.
Другие имена:
|
|
Экспериментальный: the three strategies
Educational strategy, Screening strategy and Environmental strategy were carried out in high school.
|
1.Educational strategy.
The strategy is to implement health promotion actions aiming at developing personal skills to adopt healthy behaviors in the field of nutrition and physical activity in conformity with up-to-date recommendations and references.
Each adolescent will be provided with about 50 education hours distributed in individual and collective activities in school (15 hours), interventions during courses (20 hours), and outdoors activities (15 hours).
Другие имена:
2. Screening strategy.
Screening includes measurement of BMI and plotting the growing chart with adolescents, measurement of eating troubles.
Screening will be performed by the school medical and nurse team.
At risk subjects will be defined according to precise criteria and will be referred to the GP and to obesity networks developed by Health Insurance system where they are provided with specific activities with dieticians, physical activity teachers and psychologists.
Subjects with psychological difficulties will be referred for psychological care.
Другие имена:
3. Environmental strategy.
The strategy is to develop in schools favorable and supportive environments for healthy behaviors targeting the collective catering and physical activity offer and the establishment policy.
Especially actions aim at increase fruits and vegetables availability, water consumption, physical activity inside the schools.
Другие имена:
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
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Overweight and obesity according to IOTF references
Временное ограничение: 0-1-2 years
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0-1-2 years
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Вторичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
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Knowledge, attitude and behaviors toward nutrition (food and physical activity)
Временное ограничение: 0-1-2 years
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0-1-2 years
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Соавторы
Следователи
- Главный следователь: Serge Briançon, Pr, Public Health School
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- Manneville F, Briancon S, Legrand K, Langlois J, Lecomte E, Omorou AY, Guillemin F. Physical Activity and Eating Behavior Inequalities Mediating the Effects of Socioeconomic Status and Sex on Adolescent Quality of Life: Insights of the PRALIMAP Trial. J Phys Act Health. 2022 Sep 13;19(10):648-657. doi: 10.1123/jpah.2022-0093. Print 2022 Oct 1.
- Langlois J, Omorou AY, Vuillemin A, Briancon S, Lecomte E; PRALIMAP Trial Group. Association of socioeconomic, school-related and family factors and physical activity and sedentary behaviour among adolescents: multilevel analysis of the PRALIMAP trial inclusion data. BMC Public Health. 2017 Feb 8;17(1):175. doi: 10.1186/s12889-017-4070-9.
- Omorou AY, Langlois J, Lecomte E, Vuillemin A, Briancon S; PRALIMAP Trial Group. Adolescents' Physical Activity and Sedentary Behavior: A Pathway in Reducing Overweight and Obesity. The PRALIMAP 2-Year Cluster Randomized Controlled Trial. J Phys Act Health. 2015 May;12(5):628-35. doi: 10.1123/jpah.2014-0035. Epub 2014 Nov 13.
- Bonsergent E, Agrinier N, Thilly N, Tessier S, Legrand K, Lecomte E, Aptel E, Hercberg S, Collin JF, Briancon S; PRALIMAP Trial Group. Overweight and obesity prevention for adolescents: a cluster randomized controlled trial in a school setting. Am J Prev Med. 2013 Jan;44(1):30-9. doi: 10.1016/j.amepre.2012.09.055.
- Legrand K, Bonsergent E, Latarche C, Empereur F, Collin JF, Lecomte E, Aptel E, Thilly N, Briancon S. Intervention dose estimation in health promotion programmes: a framework and a tool. Application to the diet and physical activity promotion PRALIMAP trial. BMC Med Res Methodol. 2012 Sep 19;12:146. doi: 10.1186/1471-2288-12-146.
- Briancon S, Bonsergent E, Agrinier N, Tessier S, Legrand K, Lecomte E, Aptel E, Hercberg S, Collin JF; PRALIMAP Trial Group. PRALIMAP: study protocol for a high school-based, factorial cluster randomised interventional trial of three overweight and obesity prevention strategies. Trials. 2010 Dec 6;11:119. doi: 10.1186/1745-6215-11-119.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 сентября 2006 г.
Первичное завершение (Действительный)
1 декабря 2009 г.
Завершение исследования (Действительный)
1 декабря 2009 г.
Даты регистрации исследования
Первый отправленный
23 декабря 2008 г.
Впервые представлено, что соответствует критериям контроля качества
24 декабря 2008 г.
Первый опубликованный (Оценивать)
25 декабря 2008 г.
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
30 июня 2010 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
29 июня 2010 г.
Последняя проверка
1 марта 2010 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- pralimap-0610
- CNIL-906312
- CCTIRS-06.376
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования Масса тела
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ACADIA Pharmaceuticals Inc.РекрутингLewy Body Demence PsychosisСоединенные Штаты, Чехия, Сербия, Франция, Болгария, Италия
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ACADIA Pharmaceuticals Inc.Запись по приглашениюLewy Body Demence PsychosisСоединенные Штаты, Чехия, Болгария
Клинические исследования Educational strategy
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University of WashingtonNational Institute of Mental Health (NIMH); Kenyatta National Hospital; University...РекрутингНаука реализации | Подростковая ВИЧ-инфекция | Стратегии реализации | Переход на уход за взрослымиКения
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University of MichiganNational Heart, Lung, and Blood Institute (NHLBI)Завершенный