Diabetes Prevention In Estrie
Comparative Evaluation of the Effectiveness of 2 Available Resources in Estrie, for the Prevention of Type 2 Diabetes in High-risk Subjects
This study compared the efficacy at one year of an interdisciplinary approach including individual counseling and group seminars versus group seminars alone to induce weight loss in subjects at high risk of developing type 2 diabetes.
This study also compare if a participant's presence in small informative meeting groups as the only form of intervention is sufficient to induce a lifestyle change, thus inducing the weight loss needed for the prevention of the diseases associated with obesity.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Eligible participants will be randomized into 2 intervention groups (30 per group):
- Small Meeting groups: a curriculum of 25 meeting-seminars will take place for 45 minutes, each one approaching various aspects of nutrition, physical activity, psychology, motivation and medical needs. These seminars are administered by the professionals of the obesity clinic and are already in place. However, these are usually only offered to the patients registered with the obesity clinic.
- Obesity Clinic of CHUS: combination of 25 described meeting-seminars see-high, in addition to individual interviews every 6 weeks with the interdisciplinary team of the obesity clinic of CHUS (usual operation).
Subjects will be evaluated initially and then every 3 months during 1 year by the following measurements: questionnaires to evaluate motivation and physical activity; 3 day dietary journals; weight assessment, using both metabolic and mechanical balance; waist circumference; and blood pressure.
A medical evaluation with size measure, a test evaluating knowledge of the participants on obesity, OGTT (Oral Glucose Tolerance Test) - a 5 hour determination of secretion and resistance to insulin, insulin-mediated suppression of plasma non-esterified fatty acids, a plasma lipid profile, accelerometry, bio electric impedance, and an activity physical test (6 minute walk test) will be carried out initially, and then repeated for up to 1 year.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Quebec
-
Sherbrooke, Quebec, Canada
- Centre de Recherche Clinique (CRC), Centre Hospitalier Universitaire de Sherbrooke
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- pre diabetic state underlined by a marginal fasting glycemia between 6,1 and 6,9 mmol/L and/or a glucose intolerance with glucose confirmed by an OGTT 2 hours
- overweight or obesity (BMI > 27 kg/m² ; (Body Mass Index))
- enlightened assent
Exclusion Criteria:
- Impossibility to be present at the visits
- Physical/motor incapacity (or other) making one unable and/or insecure to walk at a moderate to rapid speed of 6 min and more
- Use of an anti-obesity treatment during the last 3 months
- Bariatric Surgery in the past
- Planned Pregnancy
- Pacemaker
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 1
interdisciplinary weight loss intervention
|
one-year individualized interdisciplinary weight loss program vs. small group seminars on healthy lifestyle
|
|
Comparatore attivo: 2
Small group seminars without interdisciplinary intervention
|
one-year individualized interdisciplinary weight loss program vs. small group seminars on healthy lifestyle
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
a weight loss of 7% in at least 19% of the subjects
Lasso di tempo: one year
|
one year
|
|
reduced body weight of at least 5.6 kg in at least 25% of the subjects
Lasso di tempo: one year
|
one year
|
|
an increase in the level of physical activity by at least 150 minutes per week in at least 29% of the subjects
Lasso di tempo: one year
|
one year
|
|
a reduced daily caloric intake of at least 450 kcal/jour in at least 25% of the subjects
Lasso di tempo: one year
|
one year
|
|
a reduced percentage of the calories introduced in the form of fat of at least 6.6%, in absolute value, in at least 25% of the subjects
Lasso di tempo: one year
|
one year
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
change in insulin sensitivity by HOMA
Lasso di tempo: one year
|
one year
|
|
change in insulin secretion during an OGTT by deconvolution of plasma c-peptide
Lasso di tempo: one year
|
one year
|
|
change in beta cell function by calculation of the disposition index
Lasso di tempo: one year
|
one year
|
|
change in insulin-mediated suppression of plasma non-esterified fatty acids during an OGTT
Lasso di tempo: one year
|
one year
|
|
relation between weight loss and change in insulin sensitivity, beta cell function, and insulin-mediated suppression of plasma non-esterified fatty acids
Lasso di tempo: one year
|
one year
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Marie-France Langlois, MD, Medecine Department, Division of endocrinology, CHUS
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 04-087
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