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Body WeightPRALIMAPNCT00814554

Effectiveness Evaluation of Three Strategies of Promotion of Healthy Dietary and Physical Activity Behaviours to Prevent Weight Excess Among Teenagers

A study testing Educational strategy, Screening strategy and Environmental strategy in people with Body Weight and Nutrition Processes, run by University of Nancy at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Body Weight, Nutrition Processes, Prevention
What is being tested?
Educational strategy, Screening strategy and Environmental strategy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,458 participants
Where
1 siteFrance
Study dates
Sep 2006to Dec 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Being student in the included public high school in Region of Lorraine (East of France) whatever the age

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

France1 site

  • Nancy-University

    Vandœuvre-lès-Nancy, 54500

Other trials in France

About this study

Official title: 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.

Read the detailed description

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.

Being tested
Educational strategy, Screening strategy, Environmental strategy
Keywords
obesity, nutrition, cluster randomized trial, high school, primary prevention
Medical subject headings
Body Weight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Educational strategyBehavioural

    Also called Axe 1

    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).

  • Screening strategyBehavioural

    Also called Axe 2

    1. 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.

  • Environmental strategyOther

    Also called Axe 3

    1. 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.
Study groups in NCT00814554
Study groupRoleWhat they receive
controlNo interventionno intervention was carried out in high school
Educational strategyExperimentalEducational strategy was carried out in high school.
Receives: Behavioral: Educational strategy
Screening strategyExperimentalScreening strategy was carried out in high school.
Receives: Behavioral: Screening strategy
Environmental strategyExperimentalEnvironmental strategy was carried out in high school.
Receives: Other: Environmental strategy
Educational and Screening strategiesExperimentalEducational strategy and Screening strategy were carried out in high school
Receives: Behavioral: Educational strategy; Behavioral: Screening strategy
Screening and Environmental strategiesExperimentalScreening strategy and Environmental strategy were carried out in high school
Receives: Behavioral: Screening strategy; Other: Environmental strategy
Educational and Environmental strategiesExperimentalEducational strategy and Environmental strategy were carried out in high school
Receives: Behavioral: Educational strategy; Other: Environmental strategy
the three strategiesExperimentalEducational strategy, Screening strategy and Environmental strategy were carried out in high school.
Receives: Behavioral: Educational strategy; Behavioral: Screening strategy; Other: Environmental strategy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overweight and obesity according to IOTF references

    Measured: 0-1-2 years

Secondary outcomes (1)

  1. Knowledge, attitude and behaviors toward nutrition (food and physical activity)

    Measured: 0-1-2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Dec 2008 (estimated)
  2. Study startSep 2006
  3. Primary completionDec 2009
  4. Study completionDec 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
5,458 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00814554
Sponsor's protocol ID
pralimap-0610
Other IDs
CNIL-906312, CCTIRS-06.376
Acronym
PRALIMAP
Status last verified
Mar 2010
First submitted
23 Dec 2008
Last updated
30 Jun 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 36100207

  • 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.

    PubMed 28178972

  • 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.

    PubMed 25393601

  • 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.

    PubMed 23253647

  • 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.

    PubMed 22992391

  • 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.

    PubMed 21134278

Questions about this trial

What is this clinical trial studying?

A study testing Educational strategy, Screening strategy and Environmental strategy in people with Body Weight and Nutrition Processes, run by University of Nancy at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overweight and obesity according to IOTF references (time frame: 0-1-2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00814554, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2010.

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