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Feasibility of Technology Mediated Lifestyle Intervention for Overweight and Obese Young Adults (Rashakaty)

3 de junio de 2021 actualizado por: Habiba I. Ali, United Arab Emirates University

Development, Implementation and Evaluation of Technology Mediated Lifestyle Intervention for Promoting Weight Loss and Improving Nutrition Behaviors Among Young Adults

Rashakaty (Fitness for Me) study aimed to design a new technologies-based intervention using a website and smart phone applications and to test the feasibility of implementing a lifestyle intervention using these technologies for overweight and obese university students. The intervention was implemented in two universities in the United Arab Emirates

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

Poor eating habits and sedentary lifestyle are common among young adults and increase risk for chronic diseases in subsequent years of life. Rashakaty (Fitness for Me) study aimed to design a new technologies-based intervention using a website and smart phone applications and to test the feasibility of implementing a lifestyle intervention using these technologies for overweight and obese university students. The study intervention was guided by Social Cognitive Theory. The study involved the development of a website, integrating educational material and mobile applications for monitoring diet and physical activity and a16-week feasibility trial to promote weight loss, improve food choices and increase physical activity levels. The trial consisted of two arms: Rashakaty Basic (R-Basic) and Rashakaty Enhanced (R-Enhanced).

Tipo de estudio

Intervencionista

Inscripción (Actual)

246

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

    • Select State Or Region
      • Al Ain, Select State Or Region, Emiratos Árabes Unidos
        • United Arab Emirates University

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

18 años a 35 años (Adulto)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Femenino

Descripción

Inclusion Criteria:

  • Overweight or obese (BMI ≥25.0
  • Adults: Female
  • Age: 18-35 years
  • Current user of a smart phone
  • Student in one of the two target universities in the United Arab Emirates
  • Living in or off the university campus

Exclusion Criteria:

  • Past or planned weight loss surgery
  • Pregnant or breastfeeding
  • Lost 7 kg in the past 3 months
  • Following any weight loss program for 3 months or more
  • Taking any steroid or thyroid hormones treatment or any other medication that may affect body weight
  • Enrolled in medical and nutrition programs since one of the program components was nutrition knowledge assessments

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: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Rashakaty Basic (R-Basic)
Participants in the R-Basic intervention arm had access to a website that contained the study questionnaires and nutrition education materials
Participants in the R-Basic arm received access to a static website that contained educational materials on healthier eating and physical activity and the study questionnaires. The R-Basic intervention was implemented in the University of Sharjah.
Otros nombres:
  • Rashakaty Basic intervention
Experimental: Rashakaty Enhanced (R-Enhanced)
Participants in the R-Enhanced intervention were given access to smart phones applications for monitoring diet and physical activity levels as well as an online access to a nutritionist
The R-Enhanced intervention was guided by the Social Cognitive Theory and employed a variety of behavior modification strategies, including self-monitoring, goal setting, self-efficacy, and social support to facilitate changes in diet and physical activity. In addition, participants in the R-Enhanced intervention had online access to a nutritionist. The R-Enhanced intervention was implemented in the United Arab Emirates University.
Otros nombres:
  • Rashakaty Enhanced intervention

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Body weight
Periodo de tiempo: 16 weeks
changes in body weight
16 weeks
Body composition
Periodo de tiempo: 16 weeks
Changes in body composition (percent body fat)
16 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Nutrition knowledge
Periodo de tiempo: 16 weeks
The General Nutrition Awareness Questionnaire (GNKQ) validated by Parmenter and Wardle in the UK. was used after local adaptation. Four main categories containing a total of 58 items were assessed:1) Awareness of dietary recommendations (11 items); 2) Knowledge of sources of nutrients (37 items); (3) Using the information to make dietary choices (5 items); and 4) Awareness of diet-disease relationships (5 items).
16 weeks
Physical activity
Periodo de tiempo: 16 weeks
Changes in physical activity (number of days and duration) was used using The International Physical Activity Questionnaire (IPAQ) - Short Form
16 weeks
Perceived social support from family and closest friends.
Periodo de tiempo: 16 weeks
Perceived social support for healthier foods and physical activity scale of Health Beliefs Questionnaire which was originally developed by Anderson, E. and colleagues was used after adaptation for university students in the UAE. The social support subscale (16 items for healthy eating and 7 items for physical activity) measures social influences on participants by their family members and closest friends. Each question is scored 1-5 (1 - Strongly disagree, 5 - Strongly agree).
16 weeks
Perceived self-efficacy for healthier eating and physical activity
Periodo de tiempo: 16 weeks
Perceived self-efficacy scale of Health Beliefs Questionnaire which was originally developed by Anderson, E. and colleagues after local adaptation was used. It consists of 33 items for healthy eating and 24 items for physical activity. The healthy food efficacy measure assesses the respondent's confidence in reducing fat, reducing sugar consumption and increasing fruit and vegetable intake. The physical activity measure consists of two subscales: overcoming barriers to engaging in physical activity and integrating physical activity into the daily routine. Each question is scored 0 to 100 (certain I cannot) to 100) all or most of the time.
16 weeks

Colaboradores e Investigadores

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

Colaboradores

Investigadores

  • Investigador principal: Habiba I Ali, PhD, RD, CDE, United Arab Emirates University

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 (Actual)

21 de agosto de 2016

Finalización primaria (Actual)

31 de mayo de 2017

Finalización del estudio (Actual)

31 de mayo de 2017

Fechas de registro del estudio

Enviado por primera vez

30 de mayo de 2021

Primero enviado que cumplió con los criterios de control de calidad

3 de junio de 2021

Publicado por primera vez (Actual)

9 de junio de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de junio de 2021

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

3 de junio de 2021

Última verificación

1 de junio de 2021

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 33/2014/2015

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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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