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- Ensayo clínico NCT01957800
Weight Loss and Healthy Diet Through Mobile Phone-enabled Social Interactions
31 de agosto de 2015 actualizado por: Christopher Sciamanna, MD, MPH, Milton S. Hershey Medical Center
Enhancing the Sustainability of Weight Loss and Healthy Diet Through Mobile Phone-enabled Social Interactions
A randomized controlled trial comparing the effects of the social-enabled internet weight loss and diet change intervention with the delayed treatment group for 3 months.
We will study the effect of adding social interactions and supports to an Internet weight loss and diet change intervention.
The website intervention will have action planning with social interactions and support features for sharing, reusing, recommending, and discussing strategies for improving habits.
We hypothesize that the intervention group with access to the website will lose more weight than the delayed treatment group after three months.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Over the past two decades a very simple, low-cost and consistently effective intervention has been developed that we believe has potential to be disseminated online in primary care.
The intervention, "action planning" (AP), is also known as "if-then planning" or "implementation intentions".
Action Planning is one element of the process of self-regulation (Wing et al 2006; Luszczynska et al 2007), in which individuals identify (1) situations that challenge their ability to perform a behavior and (2) make a specific plan for what they will do when the situation is next encountered.
Luszczynska and colleagues observed that adding a single session of action planning onto a portion-controlled meal intervention increased the weight lost from 2.1 kg to 4.2 kg (Luszczynska et al 2007).
A meta-analysis of 94 studies using AP, nearly all of which included a single-dose, observed a mean effect size of Cohen's d=.65, consistent with a medium to large effect.
Studies of repeated doses appear to have even greater effects (Chapman and Armitage 2010).
Dr. Sciamanna recently completed a pilot feasibility study in which 53 subjects used an AP intervention for weight loss for 2 months.
All subjects attended a 1-hour introductory session about the use of portion-controlled meals and pedometers.
Subjects were then emailed one AP writing prompt each day, representing one of the 21 of the most common barriers to weight control (Bond et al 2001).
Despite receiving no personalized feedback, over 2 months the subjects wrote action plans, on an average of 4.2 days per week.
After 2 months, the average weight loss was 7.7 pounds.
These adherence levels, though short-term, are greater than typical web-based weight control interventions included in a recent Cochrane review (Wieland 2012).
This pilot study suggests that this low-cost intervention approach may have unusual levels of fidelity.
Even though the average activities of user engagement with AP is quite high in the first two months, there is a slight decline toward the third month.
In focus group discussions after a pilot conducted by Dr. Sciamanna in the Philadelphia area, participants of the pilot indicated consistent difficulties in coming up with ideas for habits that might be useful.
These observations motivates this proposed study.
Tipo de estudio
Intervencionista
Inscripción (Actual)
102
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Pennsylvania
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Hershey, Pennsylvania, Estados Unidos, 17033
- Penn State Milton S. Hershey Medical Center
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
21 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Between 21-65 years old
- English speaking
- BMI from 27-50 kg/m2
- Access to the Internet at home or work for most days of the week
- Have current service for a smart phone with a camera and texting capability
- Able to use mobile phone to take a picture and send it to someone
- Able to use mobile phone to look for information on the internet using a search engine (such as Google)
- Able to use mobile phone to send and receive text messages
- Able to use mobile phone to send and receive emails
- Access to a scale at home
Exclusion Criteria:
- Pregnant or planning to become pregnant in the next 3 months
- Planning on moving out of the area in the next 6 months
- Weigh more than 300 pounds
- Participating in an internet or community weight loss program
- Taking medication, prescription or over the counter for weight loss
- Doctor has said you have a heart condition and should only do physical activity recommended by a doctor
- Feel pain in chest when doing physical activity
- In the past month feel pain in chest when not doing physical activity
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿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: Website
Group will be asked to complete a daily plan online for specific situations that tempt people to overeat.
The website can be accessed online using a computer or smart phone and will allow participants to view others' plans.
Participants will also be asked to enter their weight online every week.
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Website will have action planning with social interactions and support features for sharing, reusing, and recommending strategies for improving habits.
Participants will record their weight and complete surveys online.
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Comparador activo: Usual Care
Group will be given access to the online intervention after the 3-month study ends.
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Participants will record their weight and complete surveys online.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Body Weight
Periodo de tiempo: 3 months
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Body weight will be measured by a research assistant using a portable, digital scale.
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3 months
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Demographics
Periodo de tiempo: 3 months
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We will measure age, gender, race and ethnicity, smoking status, education and other demographics, based on standard self-report.
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3 months
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Hospital and Anxiety Scale
Periodo de tiempo: 3 months
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This self-assessment scale has been found to be a reliable instruction for detecting states of depression and anxiety.
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3 months
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International Physical Activity Questionnaire
Periodo de tiempo: 3 months
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The survey comprises a set of 4 questionnaires.
The purpose of the questionnaires is to provide common instruments that can be used to obtain internationally comparable data on health-related physical activity.
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3 months
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Medications
Periodo de tiempo: 3 months
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We will measure dose and quantity of all prescribed medications based on standard self-report.
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3 months
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Motivation scale
Periodo de tiempo: 3 months
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This questionnaire asks participants how motivated they are to control their weight using non-comparative scaling.
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3 months
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Three Factor Eating Questionnaire
Periodo de tiempo: 3 months
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The questionnaire measures three dimensions of dietary restraint: cognitive restraint, disinhibition, perceived hunger.
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3 months
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Weight Loss Habits
Periodo de tiempo: 3 months
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This questionnaire asks participants to rate their frequency of use of weight loss habits using non-comparative scaling.
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3 months
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Adherence
Periodo de tiempo: 3 months
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We will examine daily journal completion data overall (mean and median) and as percentage.
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3 months
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Satisfaction
Periodo de tiempo: 3 months
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This questionnaire asks participants to provide feedback about the study.
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3 months
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Sedentary Behavior Questionnaire
Periodo de tiempo: 3 months
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3 months
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Well Being
Periodo de tiempo: 3 months
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3 months
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Weight Efficacy Questionnaire
Periodo de tiempo: 3 months
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3 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Christopher Sciamanna, MD, MPH, Milton S. Hershey Medical Center
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de octubre de 2013
Finalización primaria (Actual)
1 de noviembre de 2014
Finalización del estudio (Actual)
1 de noviembre de 2014
Fechas de registro del estudio
Enviado por primera vez
30 de septiembre de 2013
Primero enviado que cumplió con los criterios de control de calidad
30 de septiembre de 2013
Publicado por primera vez (Estimar)
8 de octubre de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
1 de septiembre de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
31 de agosto de 2015
Última verificación
1 de agosto de 2015
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 43474EP
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