Intermittent Versus Continuous Low-Energy Diet in Patients With Type 2 Diabetes: Protocol for a Pilot Randomized Controlled Trial
Notice bibliographique
Résumé
BACKGROUND: Intensive face-to-face weight loss programs using continuous low-energy diets (CLEDs) providing approximately 800 kcal per day (3347 kJ per day) can produce significant weight loss and remission from type 2 diabetes (T2D). Intermittent low-energy diets (ILEDs) and remotely delivered programs could be viable alternatives that may support patient choice and adherence. OBJECTIVE: This paper describes the protocol of a pilot randomized controlled trial to test the feasibility and potential efficacy of remotely supported isocaloric ILED and CLED programs among patients with overweight and obesity and T2D. METHODS: A total of 79 participants were recruited from primary care, two National Health Service hospital trusts, and a voluntary T2D research register in the United Kingdom. The participants were randomized to a remotely delivered ILED (n=39) or CLED (n=40). The active weight loss phase of CLED involved 8 weeks of Optifast 820 kcal/3430 kJ formula diet, followed by 4 weeks of food reintroduction. The active weight loss phase of ILED (n=39) comprised 2 days of Optifast 820 kcal/3430 kJ diet and 5 days of a portion-controlled Mediterranean diet for 28 weeks. Both groups were asked to complete 56 Optifast 820 kcal/3430 kJ days during their active weight loss phase with an equivalent energy deficit. The diets were isocaloric for the remainder of the 12 months. CLED participants were asked to follow a portion-controlled Mediterranean diet 7 days per week. ILED followed 1-2 days per week of a food-based 820 kcal/3430 kJ diet and a portion-controlled Mediterranean diet for 5-6 days per week. Participants received high-frequency (weekly, fortnightly, or monthly depending on the stage of the trial) multidisciplinary remote support from a dietitian, nurse, exercise specialist, and psychologist via telephone or the Oviva smartphone app. The primary outcomes of the study were uptake, weight loss, and changes in glycated hemoglobin at 12 months. An outcome assessment of trial retention was retrospectively added. Secondary outcomes included an assessment of adherence and adverse events. A qualitative evaluation was undertaken via interviews with participants and health care professionals who delivered the intervention. RESULTS: A total of 79 overweight or obese participants aged 18-75 years and diagnosed with T2D in the last 8 years were recruited to the Manchester Intermittent and Daily Diet Diabetes App Study (MIDDAS). Recruitment began in February 2018, and data collection was completed in February 2020. Data analysis began in June 2020, and the first results are expected to be submitted for publication in 2021. CONCLUSIONS: The outcomes of the MIDDAS study will inform the feasibility of remotely delivered ILED and CLED programs in clinical practice and the requirement for a larger-scale randomized controlled trial. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN) 15394285; http://www.isrctn.com/ISRCTN15394285. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/21116.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,030 | 0,027 |
| Méta-épidémiologie (sens strict) | 0,006 | 0,003 |
| Méta-épidémiologie (sens large) | 0,011 | 0,005 |
| Bibliométrie | 0,003 | 0,004 |
| Études des sciences et des technologies | 0,004 | 0,004 |
| Communication savante | 0,004 | 0,003 |
| Science ouverte | 0,004 | 0,002 |
| Intégrité de la recherche | 0,006 | 0,009 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,075 | 0,011 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».