- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00891943
A Trial of One to One Weight Management in Primary Care
A Randomised Controlled Trial of a One to One Weight Management Intervention in Primary Care
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Primary care could make a substantial impact on the increasing prevalence of overweight and obesity and their associated adverse impact on health. The lack of a proven intervention may deter health professionals in primary care from providing support to their overweight patients as few obese people recall receiving weight control advice from a health professional.
In this study we aim to conduct a large scale randomised controlled trial to assess the effectiveness of a longer-term structured lifestyle support programme provided by a research nurse and the provision of pedometers compared to usual care in overweight/ obese adults who wish to lose weight. We will assess the degree of weight loss over a period of 12 months as well as related factors such as changes in waist circumference, quality of life and cost-effectiveness of the interventions.
The research is highly relevant to policy making at both national and local levels.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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London, Royaume-Uni, WC1E 7HT
- London School of Hygiene and Tropical Medicine
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London, Royaume-Uni
- Several GP practices in the Camden and Westminster area.
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- 18 years or over
- BMI ≥ 25 kg/m2
- GP confirmation
Exclusion Criteria:
- pregnant or lactating women
- patients with renal failure, pacemakers or cancer
- participating in other research affecting weight
- Ability to complete questionnaires
- Ability to give consent
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Autre: Structured lifestyle support
Intervention group-structured lifestyle support.
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The intervention group will meet with a research nurse on 14 occasions over the 1 year research study, for structured lifestyle support, including dietary, physical activity and behavioral advice.
They will also receive a pedometer.
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Aucune intervention: Usual care for weight management
This is the control group, and they will receive "usual care" for weight management at their GP practice.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Changes in weight, waist circumference and percent body fat at 12 months.
Délai: 12 months
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12 months
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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Weight, waist circumference, and percent body fat at 6 months.
Délai: 0 and 6 months
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0 and 6 months
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BMI, blood pressure, resting heart rate; obesity and weight related quality of life, Rosenberg measure of self-esteem changes at 12 months.
Délai: 0 and 12 months
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0 and 12 months
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Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Kiran Nanchahal, MSc, London School of Hygiene and Tropical Medicine
Publications et liens utiles
Publications générales
- Noble LM, Godfrey E, Al-Baba L, Baez G, Thorogood N, Nanchahal K. Treatment fidelity in the Camden Weight Loss (CAMWEL) intervention assessed from recordings of advisor-participant consultations. BMC Obes. 2018 Sep 10;5:24. doi: 10.1186/s40608-018-0203-7. eCollection 2018.
- McCambridge J, Sorhaindo A, Quirk A, Nanchahal K. Patient preferences and performance bias in a weight loss trial with a usual care arm. Patient Educ Couns. 2014 May;95(2):243-7. doi: 10.1016/j.pec.2014.01.003. Epub 2014 Jan 13.
- Nanchahal K, Power T, Holdsworth E, Hession M, Sorhaindo A, Griffiths U, Townsend J, Thorogood N, Haslam D, Kessel A, Ebrahim S, Kenward M, Haines A. A pragmatic randomised controlled trial in primary care of the Camden Weight Loss (CAMWEL) programme. BMJ Open. 2012 May 4;2(3):e000793. doi: 10.1136/bmjopen-2011-000793. Print 2012.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- phpepw71
- Sponsors number:PHPEPW71
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