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Text2bHealthy: Using Innovative Methods in Childhood Obesity Treatment

8 de mayo de 2015 actualizado por: University of British Columbia

Text2bHealthy: Enhancing Adherence to Childhood Obesity Treatment Through the Use of Innovative Methods

In Canada, the number of obese children and adolescents has increased tremendously. Interventions addressing diet and physical activity have been successful in the short-term. However, a great number of individuals have difficulties maintaining achieved weight loss and returning to treatment sessions.

New technology interventions, through the web or delivered trough Personal Digital Assistants (PDAs) (e.g. iPhone or Blackberry), are increasingly being used in health interventions. PDAs have emerged as appealing in health interventions as they are easily accessible and their interactivity makes them well suited to promote long-term engagement in behaviour change interventions.

This study will look at the utility of supplementing a family-based lifestyle program for overweight and obese adolescents (Shapedown BC) with a PDA intervention (Text2bHealthy) focussing mainly on physical activity, sedentary behaviours, and dietary intake to maintain treatment success by improving self-management skills. Adolescents and will receive Text2bHealthy for 3-months after 3 months participation in the Shapedown BC program.

Results from this study will provide needed information on how to improve treatment adherence and maintenance outcomes through the use of innovative methods and will ultimately contribute to the improvement of long-term outcomes in obesity treatment.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Around the world, the amount of people who are overweight is increasing. This has become a public health crisis. Obesity, especially in children, is a problem because it is associated with risk for health problems and psychological issues. These problems include heart disease and poor quality of life and can happen both in childhood and later life.

Programs that help people change their lifestyle and behaviour are effective to help people lose weight and improve their mental health. In children, the main issue for treating obesity is to help the child keep weight off and to prevent a return to unhealthy behaviours. This means that long-term support is needed. But the health care system is not set up to do this because of a limited amount of resources. The aim of this study is to see if there are better long-term results if we use a technology tool along with a lifestyle program.

The aim of this study is to examine a personal digital assistant (PDA) program (Text2bHealthy) supplemented to an existing family-based group treatment for overweight and obese children. This treatment is called the British Columbia Centre for Healthy Weights (BCCHW) Shapedown BC program. The aim of this study is to see if Text2bHealthy supplemented to the Shapedown BC program helps children to keep the weight of and improves physical activity as well as fruit, vegetable, and fat intake.

We know from studies that reporting one's own behaviour, goal setting, and tailored feedback are key elements in changing health behaviours. Text2bHealthy includes these key elements. PDAs will be given to 30 10-16 year old children and adolescents after completing the Shapedown BC program. They will be explained how to use the PDA. Children who participate in the Text2bHealthy program will set weekly goals related to their physical activity, eating or sitting behaviours. Also, they will report on their lifestyle behaviours twice a week. They will receive personalized feedback on their progress. The feedback is designed to be supportive and to reinforce their behaviour in a positive way. The control group (N=30) will use a paper dairy to keep track of their lifestyle behaviours. At 0 and 3 months after completing the Shapedown BC program, measurements such as height and weight will be taken. Also, exercise and nutrition behaviour will be measured. Physical activity will be measured with pedometers and a recall and nutrition intake with questionnaires.

Because it is hard to maintain weight loss, we need to provide programs that offer the long-term support of behaviour change. Tools such as PDAs seem to be ideal to offer long-term support. For the purpose of this study, PDAs will be used as a proof of concept; the programming can be incorporated into smart phones in the future. From previous studies we know that reporting one's own behaviour seems to improve weight loss in children. Also, behaviours are more likely to be reported when using mobile phones compared to paper & pencil diaries. I am one of the first to study the effect of innovative technologies by using self-reporting, goal setting, and personalized feedback in childhood obesity treatment. We hope that the results from this study will increase our knowledge on the use and feasibility of digital devices in childhood obesity treatment.

The outcomes of this research will be used to better understand how to improve weight loss maintenance among obese children. Obesity places children at higher risk for heart disease and poor quality of life when they are adults. Thus time and cost-effective long-term support programs need to be developed to improve weight loss maintenance. This new program has the potential to improve maintenance of weight loss and healthy lifestyle in overweight and obese children and adolescents.

Tipo de estudio

Intervencionista

Inscripción (Actual)

2

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

    • British Columbia
      • Vancouver, British Columbia, Canadá, V6H 0B3
        • The British Columbia Children's Hospital

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

10 años a 16 años (Niño)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Overweight/obese teens
  • Aged 10 to 16 years
  • Completion of the Shapedown BC program
  • Being a resident of the greater metropolitan area of Vancouver
  • Not expected to move within the study time period
  • Ability to read and speak in English at a 6th grade level

Exclusion Criteria:

  • Participating in other physical activity or nutrition studies or programs such as the Weight Watchers or Jenny Craig
  • Pregnancy
  • Any co-morbidities which require immediate medical attention
  • Any musculoskeletal, cardiovascular, pulmonary, or orthopedic problems or disabilities precluding from being physically active
  • Use of a prescription medication which could interfere with the child's weight
  • Failure to complete the Shapedown BC program
  • Diagnosis of Type 1 diabetes

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
Experimental: Text2bHealthy
The intervention arm receives the Text2bHealthy program on a PDA
The intervention group uses handheld computers to keep track of their lifestyle behaviours and they will receive feedback on thier progress and tips (Text2bHealthy)
Sin intervención: Control group
The control group will complete a paper dairy to keep track of their lifestyle behaviours

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
BMI-z scores
Periodo de tiempo: 3 months
3 months

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Physical activity (physical activity recall, questions and pedometer steps)
Periodo de tiempo: 3 months
3 months
Nutrition
Periodo de tiempo: 3 months
3 months
Sitting behaviour (recall)
Periodo de tiempo: 3 months
3 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Louise Masse, PhD, University of British Columbia

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 marzo de 2013

Finalización primaria (Actual)

1 de agosto de 2014

Finalización del estudio (Actual)

1 de agosto de 2014

Fechas de registro del estudio

Enviado por primera vez

18 de febrero de 2013

Primero enviado que cumplió con los criterios de control de calidad

25 de febrero de 2013

Publicado por primera vez (Estimar)

27 de febrero de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

12 de mayo de 2015

Última actualización enviada que cumplió con los criterios de control de calidad

8 de mayo de 2015

Última verificación

1 de mayo de 2015

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • H12-03175

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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