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Completed

NCT Number: NCT05273892

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Life Course Sciences

London, SE1 9NH, United Kingdom

About this 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.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diet + Activity + Sleep

Behavioral

Personalized lifestyle behavior change counselling

Diet + Activity

Behavioral

Personalized lifestyle behavior change counselling

Primary outcomes

  1. Engagement

    Time frame: 14 weeks

    Percentage of eligible volunteers consented

  2. Attrition

    Time frame: 14 weeks

    Percentage drop out

  3. Intervention adherence

    Time frame: 14 weeks

    Participants complying with intervention.

  4. Intervention adherence - sleep

    Time frame: 14 weeks

    Sleep hygiene adherence; Scores will range from 0 - 52, with higher scores representing poorer sleep hygiene

Secondary outcomes

  1. Change in body weight

    Time frame: 14 weeks

    Difference from baseline to post intervention in body weight (kg)

  2. Change in energy and macro nutrient intake

    Time frame: 14 weeks

    Difference in energy intake (Kcal), and sources of energy (carbohydrates, fats, and protein)

  3. Change in sleep duration

    Time frame: 14 weeks

    Difference in between baseline and post intervention (hours/night)

  4. Change in physical activity intensity and duration

    Time frame: 14 weeks

    Difference in activity from MotionWatch (duration hours in vigorous and moderate activity)

  5. Change in sleep quality score

    Time frame: 14 Weeks

    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

  6. Change in work engagement score

    Time frame: 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.

  7. Change in anxiety questionnaire score

    Time frame: 14 weeks

    Difference in generalized anxiety (GAD-7) questionnaire score.Range 0 to 21. Higher score = higher anxiety level.

  8. Change in depression questionnaire score

    Time frame: 14 weeks

    Difference in PHQ9 depression questionnaire score.Range 0 to 27. Higher score = more likely depressive symptoms.

  9. Change in reported level of burn out

    Time frame: 14 weeks

    Difference in Oldenberg Burnout Inventory score, higher score = more burnout signs/symptoms

  10. Change in day time sleepiness

    Time frame: 14 weeks

    Difference in Epworth Sleepiness Scale. Range 0 to 24 - higher score = more daytime sleepiness

Other outcomes

  1. Change in job satisfaction score

    Time frame: 14 weeks

    Difference in job satisfaction questionnaire score.Score between 5 and 25. Higher score= more job satisfaction.

Sponsors and collaborators

Lead sponsor

King's College London

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 10, 2022
Registry last updated
Oct 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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