Primary PreventionELPASNCT00456911
Family Dietary Coaching to Improve Nutritional Intakes and Body Weight Control
A study of Primary Prevention and Obesity Prevention, run by Centre d'Etudes et de Documentation du Sucre at 1 site in France.
Trial summary
We hypothesize that Family Dietary Coaching for one school year will allow a nutritional shift towards following recommendations and improve health indicators in free-living children and adults. Read more about this study
- Who is it for?
- Ages 6 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Prevention, Obesity Prevention, Body Weight Control
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,020 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2005to Jul 2006
- 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 6 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- second- or third-grade pupils
- affiliation with the French Health Care System
- written informed consent
- Exclusion Criteria: no inclusion criteria were based on pathological, ethnical or socio-educative indicators
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Longitudinal Study on Health and Diet (Etude Longitudinale Prospective Alimentation et Santé)
We hypothesize that Family Dietary Coaching for one school year will allow a nutritional shift towards following recommendations and improve health indicators in free-living children and adults.
Read the detailed description
Insufficient evidence supports the feasibility and the efficacy of current nutritional recommendations to prevent obesity. The purpose of this study is to test the hypothesis that family dietary coaching would improve nutritional intakes and health indicators in free-living children and adults.
Intervention: the 1013 participating families (1013 children and 1013 parents) are randomly assigned to Group A (advice to reduce fat and to increase complex carbohydrates), Group B (advice to reduce both fat and sugars and to increase complex carbohydrates) or a control group (no advice). GA and GB receive monthly phone counseling and Internet-based monitoring. Main outcome measures are changes in nutritional intakes and body mass index throughout the intervention in both children and adults. Secondary outcomes included changes in fat mass, physical activity, fasting blood indicators and food-related quality of life.
- Conditions
- Primary Prevention, Obesity Prevention, Body Weight Control
- Being tested
- Fat and carbohydrate controlled diet
- Keywords
- obesity, prevention, children, adults, family, dietary, coaching, body mass index, fat mass
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fat and carbohydrate controlled dietBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in body mass index throughout the intervention
Secondary outcomes (6)
changes in nutritional intakes throughout the intervention
changes in fat mass throughout the intervention
changes in anthropometric indicators throughout the intervention
changes in physical activity throughout the intervention
changes in fasting blood indicators throughout the intervention (adults only)
changes in food-related quality of life throughout the intervention (adults only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2007 (estimated)
- Study startMar 2005
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 2,020 participants
Sponsor and investigators
- Lead sponsor
- Centre d'Etudes et de Documentation du Sucre
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Higher Education and Research, France, Paris Academy (Rectorat de Paris), Avenance Enseignement, Fondation Louis Bonduelle
- Investigators
- Alain BOULIER, MD, PHD, Study chair, Department of Nutrition and Functional Investigations, INSERM U695, Bichat-Claude Bernard Hospital, Paris, FranceDominique-Adèle CASSUTO, MD, Study chair, Paris, FranceJudith CHWALOW, PHD, Study chair, Department of Nutrition, EA3502, Hôtel-Dieu, Paris, FrancePierre COMBRIS, PHD, Study chair, INRA-CORELA, Ivry-sur-Seine, FranceCharles COUET, MD, Study chair, INSERM E211, Tours Hospital, Tours, FranceBéatrice JOURET, MD, Study chair, Department of Pediatrics, Children's Hospital, Toulouse, FranceMonique ROMON, MD, Study chair, Department of Nutrition, EA2694 Lille2 University, Lille, FranceChantal SIMON, MD, PhD, Study chair, Louis Pasteur University, Medical Faculty, EA 1801, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00456911
- Sponsor's protocol ID
- ELPAS 2002-RN31
- Acronym
- ELPAS
- Status last verified
- Apr 2007
- First submitted
- 3 Apr 2007
- Last updated
- 13 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Paineau DL, Beaufils F, Boulier A, Cassuto DA, Chwalow J, Combris P, Couet C, Jouret B, Lafay L, Laville M, Mahe S, Ricour C, Romon M, Simon C, Tauber M, Valensi P, Chapalain V, Zourabichvili O, Bornet F. Family dietary coaching to improve nutritional intakes and body weight control: a randomized controlled trial. Arch Pediatr Adolesc Med. 2008 Jan;162(1):34-43. doi: 10.1001/archpediatrics.2007.2.
PubMed 18180410
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Longitudinal Study on Health and Diet (Etude Longitudinale Prospective Alimentation et Santé)
- ClinicalTrials.gov ID
- NCT00456911
- Acronym / sponsor ID
- ELPAS / ELPAS 2002-RN31
- Conditions
- Primary Prevention, Obesity Prevention, Body Weight Control
- Keywords
- obesity, prevention, children, adults, family, dietary, coaching, body mass index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,020 participants
- Lead sponsor
- Centre d'Etudes et de Documentation du SucreUniversity, hospital or other
- Collaborators
- Ministry of Higher Education and Research, France, Paris Academy (Rectorat de Paris), Avenance Enseignement, Fondation Louis Bonduelle
- Study start
- Mar 2005
- Study completion
- Jul 2006 (actual)
- First posted
- 5 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We hypothesize that Family Dietary Coaching for one school year will allow a nutritional shift towards following recommendations and improve health indicators in free-living children and adults.
Detailed description
Insufficient evidence supports the feasibility and the efficacy of current nutritional recommendations to prevent obesity. The purpose of this study is to test the hypothesis that family dietary coaching would improve nutritional intakes and health indicators in free-living children and adults.
Intervention: the 1013 participating families (1013 children and 1013 parents) are randomly assigned to Group A (advice to reduce fat and to increase complex carbohydrates), Group B (advice to reduce both fat and sugars and to increase complex carbohydrates) or a control group (no advice). GA and GB receive monthly phone counseling and Internet-based monitoring. Main outcome measures are changes in nutritional intakes and body mass index throughout the intervention in both children and adults. Secondary outcomes included changes in fat mass, physical activity, fasting blood indicators and food-related quality of life.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 6 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- second- or third-grade pupils
- affiliation with the French Health Care System
- written informed consent
- Exclusion Criteria: no inclusion criteria were based on pathological, ethnical or socio-educative indicators
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fat and carbohydrate controlled diet | Behavioural | – |
Primary outcome
changes in body mass index throughout the intervention
6 secondary outcomes
changes in nutritional intakes throughout the intervention
changes in fat mass throughout the intervention
changes in anthropometric indicators throughout the intervention
changes in physical activity throughout the intervention
changes in fasting blood indicators throughout the intervention (adults only)
changes in food-related quality of life throughout the intervention (adults only)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2008.
- Derived from this study: PubMed 18180410Paineau DL, Beaufils F, Boulier A, Cassuto DA, Chwalow J, Combris P, Couet C, Jouret B, Lafay L, Laville M, Mahe S, Ricour C, Romon M, Simon C, Tauber M, Valensi P, Chapalain V, Zourabichvili O, Bornet F. Family dietary coaching to improve nutritional intakes and body weight control: a randomized controlled trial. Arch Pediatr Adolesc Med. 2008 Jan;162(1):34-43. doi: 10.1001/archpediatrics.2007.2.
- French Ministry of Research websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain BOULIER, MD, PHD study chair
Department of Nutrition and Functional Investigations, INSERM U695, Bichat-Claude Bernard Hospital, Paris, France
Dominique-Adèle CASSUTO, MD study chair
Paris, France
Judith CHWALOW, PHD study chair
Department of Nutrition, EA3502, Hôtel-Dieu, Paris, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Primary Prevention and Obesity Prevention, run by Centre d'Etudes et de Documentation du Sucre 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 4 inclusion and 0 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 13 Feb 2008. 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?
changes in body mass index throughout the intervention. 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 NCT00456911, which also lists 1 linked publication.
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 13 Feb 2008.