Exploring the Optimal Duration of a Group-based Online Behavioral Weight Loss Program
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Obesity presents a vexing public health challenge. Effective behavioral weight control treatments are available, loss, and projections show these interventions could have a significant impact on overall population health if the interventions were more broadly available. Internet delivery of behavioral lifestyle interventions has potential for broad reach and is thus an attractive option, although average weight losses tend to be lower than in a comparable behavioral program delivered in-person. Nonetheless, internet-delivered group behavioral weight control programs which incorporate synchronous chat "group sessions" can produce an average of 5% weight loss, with almost a quarter of participants losing at least 10% of their body weight at 6-months, and thus offer weight losses which are clinically significant. Online programs are more cost effective than in-person delivery of the same program, but efforts to optimize the delivery of online programs to achieve the best weight outcomes balanced against delivery cost are in their infancy. The current feasibility study seeks to explore critical elements to allow testing of whether a moderate dose program (16 online weekly video chat sessions) can produce weight losses comparable to the higher dose (24 weekly video chat sessions) internet-delivered behavioral weight loss program which is the established standard which we have demonstrated effective in the past. This pilot study will provide proof-of-concept to determine whether the approach is promising and if it is feasible to conduct. The pilot will explore the feasibility of recruiting individuals to weight loss programs of varying duration (4 months vs. 6 months), refine our ability to deliver the 16-session program, compare 6-month weight losses between the two programs of shorter and longer duration, respectively, and obtain data to characterize weight maintenance experiences and retention over the 12-month study period.
Up to 80 individuals will be randomized into an online behavioral weight loss program lasting 4 months or 6 months. Individuals will meet weekly for one hour in a synchronous chat session with an experienced behavioral weight control counselor. Participants will be followed over 12 months from study start.
Tipo de estudio
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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South Carolina
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Columbia, South Carolina, Estados Unidos, 29208
- University of South Carolina
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Vermont
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Burlington, Vermont, Estados Unidos, 05405
- Behavioral Weight Management Program/Univ of Vermont
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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:
- female
- BMI between 25-55
- free of medical problems that might contraindicate participation in a behavioral weight reduction program containing an exercise component
- not currently on medication that might affect weight loss
- not currently pregnant or pregnant in the previous 6 months or currently breastfeeding
- not enrolled in another weight reduction program
- must have a computer (at home or work) with access to the Internet and a video camera
- must have a smart phone (to allow use of step counting and dietary intake self-monitoring apps)
- Only one member of a household will be eligible to participate
- must successfully complete a self-monitoring diary of foods consumed for a week during screening for study eligibility
- demonstrate the ability to access the website successfully (practice chat)
- agree to be randomized to either group
- must be willing to share access to self-monitoring information collected via the app MyFitnessPal, and Fitbit.com weight data collected via the digital smart scale (scale will be provided)
Exclusion Criteria:
- have had a heart attack or a stroke in the past 6 months,
- have ever had weight loss surgery,
- have lost more than 10 pounds in the previous 6 months,
- are currently taking medications for weight loss,
- are required by their doctor to follow a special diet (other than a low fat diet)
- have plans to move from the area in the upcoming 12 months
- who have schedules that will make it likely that they will have difficulty attending the scheduled "chat" groups
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Four Month Duration
Participants will meet weekly online via video chat with an experienced behavioral weight loss counselor in a synchronous 1-hour chat session for 16 weeks in a well-established behavioral weight loss program.
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Participants meet weekly on line with other group participants for 16 weeks.
The group-based online behavioral weight control program incorporates the elements of current thinking and empirical data on successful weight loss programs, including restricted calorie intake and increased physical activity.
Key behavioral strategies to facilitate making sustained changes in dietary habits and activity patterns are introduced, promoted, and reinforced throughout the program.
Weekly "group meetings" in a video chat forum led by an experienced group weight control counselor are the venue for the group process, and extensive web-based resources to support behavior changes are offered.
The online groups are "closed" such that those individuals who start the group remain in that group for the duration of their participation.
Weight loss counselor will provide feedback and encouragement to participants after reviewing food diaries via weekly emails.
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Comparador activo: Six Month Duration
Participants will meet weekly online via video chat with an experienced behavioral weight loss counselor in a synchronous 1-hour chat session for 24 weeks in a well-established behavioral weight loss program.
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Participants meet weekly on line with other group participants for 24 weeks.
The group-based online behavioral weight control program incorporates the elements of current thinking and empirical data on successful weight loss programs, including restricted calorie intake and increased physical activity.
Key behavioral strategies to facilitate making sustained changes in dietary habits and activity patterns are introduced, promoted, and reinforced throughout the program.
Weekly "group meetings" in a video chat forum led by an experienced group weight control counselor are the venue for the group process, and extensive web-based resources to support behavior changes are offered.
The online groups are "closed" such that those individuals who start the group remain in that group for the duration of their participation.
Weight loss counselor will provide feedback and encouragement to participants after reviewing food diaries via weekly emails.
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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 from baseline to 2, 4, 6 and 12 months
Periodo de tiempo: 2 months, 4 months, 6 months, 12 months
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Weight loss at each follow-up will be calculated as % kg lost from baseline.
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2 months, 4 months, 6 months, 12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Process measures: Attendance by subjects at weekly online meetings
Periodo de tiempo: 2,4,6 months
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The group facilitator will take attendance at weekly online class meetings.
Attendance at on-line meetings will be calculated as % of meetings actually attended out of 16 or 24 meetings that were scheduled according to condition assignment
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2,4,6 months
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Process measures: Completion of weekly online treatment modules by subjects
Periodo de tiempo: 2, 4, 6 months
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Completion of online treatment modules by each subject by condition will be calculated as % modules completed out of 16 or 24 modules scheduled according to condition assignment.
Module completion is defined as viewing the module and completing the online activity questions associated with each respective module.
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2, 4, 6 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Delia Smith West, PhD, University of South Carolina
- Investigador principal: Jean R Harvey, PhD, University of Vermont
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
Términos MeSH relevantes adicionales
- Peso corporal
- Cambios en el peso corporal
- Pérdida de peso
- Exceso de peso
- Efectos fisiológicos de las drogas
- Agentes adrenérgicos
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Agentes Autonómicos
- Agentes del sistema nervioso periférico
- Agonistas alfa adrenérgicos
- Agonistas adrenérgicos
- Agentes del sistema respiratorio
- Simpaticomiméticos
- Agentes vasoconstrictores
- Descongestionantes nasales
- Oximetazolina
Otros números de identificación del estudio
- CHRBSS #STUDY00000761
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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