Clinical trial NCT00456911: Family Dietary Coaching to Improve Nutritional Intakes and Body Weight Control
Official title: Prospective Longitudinal Study on Health and Diet (Etude Longitudinale Prospective Alimentation et Santé)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Prevention
Obesity Prevention
Body Weight Control
Keywords: obesity
prevention
children
adults
family
dietary
coaching
body mass index
fat mass
Lead sponsor: Centre d'Etudes et de Documentation du Sucre
Sponsor class: OTHER
Collaborators: name: Ministry of Higher Education and Research, France
name: Paris Academy (Rectorat de Paris)
name: Avenance Enseignement
name: Fondation Louis Bonduelle
First posted: 2007-04-05
Enrollment: 2020
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Primary outcomes:
measure: changes in body mass index throughout the intervention
Secondary outcomes:
measure: changes in nutritional intakes throughout the intervention
measure: changes in fat mass throughout the intervention
measure: changes in anthropometric indicators throughout the intervention
measure: changes in physical activity throughout the intervention
measure: changes in fasting blood indicators throughout the intervention (adults only)
measure: changes in food-related quality of life throughout the intervention (adults only)
Other outcomes:
Locations:
city: Paris
country: France
facility: Free-Living Participants
state: Ile de France
Study officials:
affiliation: Department of Nutrition and Functional Investigations, INSERM U695, Bichat-Claude Bernard Hospital, Paris, France
name: Alain BOULIER, MD, PHD
role: STUDY_CHAIR
affiliation: Paris, France
name: Dominique-Adèle CASSUTO, MD
role: STUDY_CHAIR
affiliation: Department of Nutrition, EA3502, Hôtel-Dieu, Paris, France
name: Judith CHWALOW, PHD
role: STUDY_CHAIR
affiliation: INRA-CORELA, Ivry-sur-Seine, France
name: Pierre COMBRIS, PHD
role: STUDY_CHAIR
affiliation: INSERM E211, Tours Hospital, Tours, France
name: Charles COUET, MD
role: STUDY_CHAIR
affiliation: Department of Pediatrics, Children's Hospital, Toulouse, France
name: Béatrice JOURET, MD
role: STUDY_CHAIR
affiliation: Department of Nutrition, EA2694 Lille2 University, Lille, France
name: Monique ROMON, MD
role: STUDY_CHAIR
affiliation: Louis Pasteur University, Medical Faculty, EA 1801, Strasbourg, France
name: Chantal SIMON, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Pediatrics, Children's Hospital, Toulouse, France
name: Maïté TAUBER, MD
role: STUDY_CHAIR
affiliation: Department of Endocrinology, CRNH Ile-de-France, Jean Verdier Hospital, Bondy, France
name: Paul VALENSI, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nutri-Health, Rueil-Malmaison, France
name: Francis BORNET, MD, PHD
role: STUDY_CHAIR
affiliation: Nutri-Health, Rueil-Malmaison, France
name: Damien PAINEAU, MS
role: STUDY_CHAIR
References:
citation: 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.