Sustainable Weight Loss Study: Nutrition Support Tools and Weight Loss Among Obese People
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Obesity is a major public health burden. Weight loss among obese participants may improve future health outcomes and financial burden to the healthcare system and employers.
The effect of personalized meal planning and online food purchasing and delivery on weight loss and management is unknown.
Design: This trial is an online, three-arm randomized trial to compare a meal planning and telenutrition tool, a meal planning tool only, and MyPlate optimization.
Participants will be assigned to randomly assigned in a 1:1:1 ratio to one of the three groups.
Participants will follow the intervention for 6 months after randomization and will be followed for an additional 1.5 years after randomization.
Participants will report dietary behavior and weight at baseline and each month of the intervention (6 months), 12 months, 18 months, and 24 months.
Population Approximately 300 participants will be enrolled and randomized (100 per arm). Participants will be adults living in New York state who are obese (at least a BMI of 30 kg/m2).
Outcomes Primary outcome: weight change after 6 months Other outcomes: waist circumference; blood pressure, dietary changes, cooking, meal planning, and eating out frequencies
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
BMI ≥ 30 kg/m2 Male or female 18 or older Non-institutionalized Able and willing to provide informed consent Willing to change diet for 3 months Has access to a scale to weigh themselves Lives in NY state
Exclusion Criteria:
Refuse or are unable to provide informed consent to participate in the study Undergoing active cancer treatment Has type 1 or 2 diabetes Stage 3+ CKD or kidney failure Are pregnant or breastfeeding, have given birth in the last three months, or are planning to be pregnant in the next 3 months Report of congestive heart failure Diagnosed with an eating disorder (e.g. anorexia nervosa or bulimia nervosa) Current or former Zipongo users
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: Nutrition and food purchasing tool + telenutrition
Participants will use an online nutrition and food purchasing tool in addition to telenutrition.
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Participants will be asked to use a meal planning and food purchasing feature regularly (at least once every two weeks) and schedule appointments with a registered dietitian.
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Comparateur actif: Nutrition and food purchasing tool
Participants will use an online nutrition and food purchasing tool.
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Participants will be asked to use a meal planning and food purchasing feature regularly (at least once every two weeks).
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Comparateur actif: Nutrition education tool
Participants will be exposed to an online nutrition education materials.
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Participants will be asked to review nutrition education materials online.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Weight change
Délai: Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
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Weight will be measured using a scale and self-reported.
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Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Waist circumference
Délai: Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
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Waist circumference will be measured using a tape measure and self-reported.
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Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
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Blood pressure
Délai: Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
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Blood pressure will be a self-reported assessment at a clinic or pharmacy.
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Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
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Change in diet quality
Délai: Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
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Diet quality will be assessed using a food frequency questionnaire.
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Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
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 (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
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
- 102
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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