Study to Test the Feasibility, Acceptability, and Weight Change of Take Off Pounds Sensibly (TOPS) in a Safety Net Clinic (TOPS at DOC)
Pilot Study to Test the Feasibility, Acceptability, and Weight Change of Take Off Pounds Sensibly (TOPS) in a Safety Net Clinic
The purpose of this pilot proposal are the following: 1) to determine the feasibility and acceptability of integrating the TOPS weight loss program into underserved populations through an urban safety net clinic and 2) to gather preliminary data of weight change to inform the design of a future randomized, controlled trial to determine the efficacy of the TOPS program in safety net clinics.
To achieve these goals, the investigators will pursue the following Specific Aims:
Specific Aim 1. Assess the feasibility and acceptability of integrating the TOPS program into an urban safety net clinic, with process measures (i.e., recruitment/refusal rates and retention/dropout rates) and focus groups.
Hypothesis 1. Integrating the TOPS program into an urban safety net clinic is feasible and acceptable to participants.
Specific Aim 2. Assess the percent of participants in the TOPS intervention arm with clinically significant weight change (i.e., weight loss of ≥5% of initial body weight) at 12, 26, and 52 weeks.
Hypothesis 2. 10%, 25%, and 33% of participants in the TOPS intervention arm will lose ≥5% of initial body weight at 12, 26, and 52 weeks, respectively.
Descripción general del estudio
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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North Carolina
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Durham, North Carolina, Estados Unidos, 27701
- Duke General Internal Medicine
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Participants must be patients of the DOC.
- BMI: Asian patients with a BMI of ≥23 kg/m2 and patients of other racial and ethnic backgrounds will be included if have a BMI of ≥25 kg/m2. Asian patients are allowed to participate at a BMI in the normal range because they are more likely to develop diabetes (or insulin resistance or glucose intolerance at a BMI of 23 kg/m2).
Exclusion Criteria:
- Mental illness that would cause disruptions to group meetings
- Cognitive impairment that would preclude participants from understanding the program
- Type 2 diabetics on insulin or sulfonylureas without provider approval
- untreated hyper- or hypothyroidism
- current cancer diagnosis
- history of cancer (other than skin cancer)
- gastrointestinal disorders affecting food intake
- use of medications thought to effect metabolism, body weight, energy expenditure, or appetite
- women currently pregnant or lactating, planning to become pregnant, or less than 6 months post-partum
- weight loss of > 5% in past 6 months
- major psychiatric disorder
- current moderate to severe symptoms of depression
- eating disorders
- current alcohol or substance abuse.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: TOPS
Participants will attend weekly TOPS meetings with standard weekly weigh ins
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Take Off Pounds Sensibly (TOPS) is a national, nonprofit, peer-led, group-based, weight loss program that offers a comprehensive program on diet and physical activity with group support for weight management.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Weight
Periodo de tiempo: Baseline, 12, 24, and 52 weeks
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Weekly weight data will be collected by the DOC Designee at baseline, 12, 24, and 52 weeks.
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Baseline, 12, 24, and 52 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Program Attendance
Periodo de tiempo: 52 Weeks
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Calculate the percentage of TOPS at DOC group session attendance (sessions attended/total offered).
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52 Weeks
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Retention as measured by attendance sheets
Periodo de tiempo: 12, 24 and 52 weeks
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Calculate the retention of participants in the TOPS at DOC program at 12, 24, and 52 weeks.
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12, 24 and 52 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Nia S Mitchell, MD, MPH, Duke University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Pro00080518
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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