Sustainable Weight Loss Study: Nutrition Support Tools and Weight Loss Among Obese People
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Nutrition and food purchasing tool + telenutrition
Participants will use an online nutrition and food purchasing tool in addition to telenutrition.
|
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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Comparador activo: 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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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Weight change
Periodo de tiempo: Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
|
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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Waist circumference
Periodo de tiempo: Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
|
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
|
|
Blood pressure
Periodo de tiempo: Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
|
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
Periodo de tiempo: Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
|
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
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 102
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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