Prospective Longitudinal Study on Health and Diet (Etude Longitudinale Prospective Alimentation et Santé)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 2,020
- Locations
- 2
- Primary Endpoint
- changes in body mass index throughout the intervention
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Single
Eligibility Criteria
- Ages
- 6 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
changes in body mass index throughout the intervention
Secondary Outcomes
- changes in nutritional intakes 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)
- changes in fat mass throughout the intervention
- changes in anthropometric indicators throughout the intervention