The KING'S WHOLE Feasibility Study
7 de octubre de 2022 actualizado por: King's College London
King's Intervention to Achieve Nutrition & Exercise Goals Supported by Lifestyle Advice for Desk-based/Work From Home Workers Delivered as a HOListic Employee Wellbeing Programme: The KING'S WHOLE Feasibility Study
Office working life has changed dramatically over the last 50 years with digitalization; this is estimated to have decreased the amount of energy (calories) used during work.
Employees who work long or irregular working hours or experience job strain are more likely to make less healthy food choices.
The combination of these factors may contribute to increased body weight during a persons working life.
The aim is to investigate the feasibility of an online lifestyle behaviour change intervention in office workers.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Office working life has changed dramatically over the last 50 years with digitalization; this is estimated to have decreased the amount of energy (calories) used during work. Employees who work long or irregular working hours or experience job strain are more likely to make less healthy food choices. The combination of these factors may contribute to increased body weight during a persons working life. The aim is to investigate the feasibility of an online lifestyle behaviour change intervention in office workers.
This feasibility randomized control trial is a remote study and will be conducted online. Participants will be randomized to one of two health and well being interventions.
The study will last 14 weeks. Participants need to attend two on-line study appointments (at the start of week 1 and end of week 14) lasting approximately 30-45 minutes.
In weeks 2, 6 and 10 participants will be asked to participate in a personalised one-to-one behaviour change on-line advice session with a research nutritionist/dietitian. Each session will last approximately 45 minutes.
In weeks 1, 5, 9 and 14 participants will be asked to wear a wrist-worn activity monitor and report what you eat and drink for 3 days.
Tipo de estudio
Intervencionista
Inscripción (Actual)
28
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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-
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London, Reino Unido, SE1 9NH
- Life Course Sciences
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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
18 años a 70 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- King's College employee (working at least 0.5 WTE)
- Work in a desk/computer-based job role
- Body mass index (BMI) that is more than 25kg/m2 and waist circumference indicative of increased cardiometabolic risk based on NHS guidelines for different ethnic groups by sex: Men - White waist circumference more than 94cm (37-in); men of Chinese, Asian, African or African-Caribbean ethnicity - more than 90cm (35.4in). Women - waist circumference more than 80 cm (31.5in)
- Sleep duration 5 - <7 hours on average on most weekdays
- Not actively loosing weight or part of weight management programme (e.g., Weight Watchers or Slimming World)
- Not under medical advice that contraindicates increasing physical activity and exercising.
- Not diagnosed with a sleep condition and have no history of chronic use of sleeping aids.
- Not diagnosed with an eating disorder.
- Not diagnosis in the last 12 months or currently requiring treatment for: heart attack, stroke, pacemaker, hepatitis or any liver disease, diabetes mellitus, chronic gastrointestinal disorders, thyroid conditions, or cancer (excluding basal carcinoma).
- No history of alcohol or drug misuse in the last 2 years.
- Own a smart phone and technology literate
Exclusion Criteria:
- - Shift worker (required to work outside 6 am and 8 pm)
- Pregnant / breastfeeding or have caring responsibilities that would prevent a participant from changing your daily routine.
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: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Diet + Activity + Sleep
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Personalized lifestyle behavior change counselling
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Comparador activo: Diet + Activity
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Personalized lifestyle behavior change counselling
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Engagement
Periodo de tiempo: 14 weeks
|
Percentage of eligible volunteers consented
|
14 weeks
|
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Attrition
Periodo de tiempo: 14 weeks
|
Percentage drop out
|
14 weeks
|
|
Intervention adherence
Periodo de tiempo: 14 weeks
|
Participants complying with intervention.
|
14 weeks
|
|
Intervention adherence - sleep
Periodo de tiempo: 14 weeks
|
Sleep hygiene adherence; Scores will range from 0 - 52, with higher scores representing poorer sleep hygiene
|
14 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in body weight
Periodo de tiempo: 14 weeks
|
Difference from baseline to post intervention in body weight (kg)
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14 weeks
|
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Change in energy and macro nutrient intake
Periodo de tiempo: 14 weeks
|
Difference in energy intake (Kcal), and sources of energy (carbohydrates, fats, and protein)
|
14 weeks
|
|
Change in sleep duration
Periodo de tiempo: 14 weeks
|
Difference in between baseline and post intervention (hours/night)
|
14 weeks
|
|
Change in physical activity intensity and duration
Periodo de tiempo: 14 weeks
|
Difference in activity from MotionWatch (duration hours in vigorous and moderate activity)
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14 weeks
|
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Change in sleep quality score
Periodo de tiempo: 14 Weeks
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Difference in score from PROMIS (Patient-Reported Outcomes Measurement Information System) questionnaire.
Scores between 8 and 40, which are converted to T-Scores (min 28.9 - 76.5).
Higher score = more disturbance
|
14 Weeks
|
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Change in work engagement score
Periodo de tiempo: 14 Weeks
|
Change in Utrecht Work Engagement Scale (UWES) questionnaire score.
Three subscales for "Vigor", "dedication" "absorption" - all have score between 0 and 6.
Higher scores = more vigor/dedication/absorption at work. 1 total UWEZ-9 Score.
Score between 0 and 6.
Higher score = more work engagement.
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14 Weeks
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Change in anxiety questionnaire score
Periodo de tiempo: 14 weeks
|
Difference in generalized anxiety (GAD-7) questionnaire score.Range 0 to 21.
Higher score = higher anxiety level.
|
14 weeks
|
|
Change in depression questionnaire score
Periodo de tiempo: 14 weeks
|
Difference in PHQ9 depression questionnaire score.Range 0 to 27.
Higher score = more likely depressive symptoms.
|
14 weeks
|
|
Change in reported level of burn out
Periodo de tiempo: 14 weeks
|
Difference in Oldenberg Burnout Inventory score, higher score = more burnout signs/symptoms
|
14 weeks
|
|
Change in day time sleepiness
Periodo de tiempo: 14 weeks
|
Difference in Epworth Sleepiness Scale.
Range 0 to 24 - higher score = more daytime sleepiness
|
14 weeks
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in job satisfaction score
Periodo de tiempo: 14 weeks
|
Difference in job satisfaction questionnaire score.Score between 5 and 25.
Higher score= more job satisfaction.
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14 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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)
7 de marzo de 2022
Finalización primaria (Actual)
30 de septiembre de 2022
Finalización del estudio (Actual)
30 de septiembre de 2022
Fechas de registro del estudio
Enviado por primera vez
1 de marzo de 2022
Primero enviado que cumplió con los criterios de control de calidad
1 de marzo de 2022
Publicado por primera vez (Actual)
10 de marzo de 2022
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de octubre de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
7 de octubre de 2022
Última verificación
1 de marzo de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KT 2021
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
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
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