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The KING'S WHOLE Feasibility Study

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05273892
Enrollment
28
Registered
2022-03-10
Start date
2022-03-07
Completion date
2022-09-30
Last updated
2022-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight or Obesity

Keywords

Employee, Lifestyle intervention, Online health and wellbeing

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALDiet + Activity + Sleep

Personalized lifestyle behavior change counselling

BEHAVIORALDiet + Activity

Personalized lifestyle behavior change counselling

Sponsors

King's College London
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Intervention adherence - sleep14 weeksSleep hygiene adherence; Scores will range from 0 - 52, with higher scores representing poorer sleep hygiene
Engagement14 weeksPercentage of eligible volunteers consented
Attrition14 weeksPercentage drop out
Intervention adherence14 weeksParticipants complying with intervention.

Secondary

MeasureTime frameDescription
Change in sleep quality score14 WeeksDifference 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
Change in work engagement score14 WeeksChange 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.
Change in anxiety questionnaire score14 weeksDifference in generalized anxiety (GAD-7) questionnaire score.Range 0 to 21. Higher score = higher anxiety level.
Change in body weight14 weeksDifference from baseline to post intervention in body weight (kg)
Change in reported level of burn out14 weeksDifference in Oldenberg Burnout Inventory score, higher score = more burnout signs/symptoms
Change in day time sleepiness14 weeksDifference in Epworth Sleepiness Scale. Range 0 to 24 - higher score = more daytime sleepiness
Change in depression questionnaire score14 weeksDifference in PHQ9 depression questionnaire score.Range 0 to 27. Higher score = more likely depressive symptoms.
Change in energy and macro nutrient intake14 weeksDifference in energy intake (Kcal), and sources of energy (carbohydrates, fats, and protein)
Change in sleep duration14 weeksDifference in between baseline and post intervention (hours/night)
Change in physical activity intensity and duration14 weeksDifference in activity from MotionWatch (duration hours in vigorous and moderate activity)

Other

MeasureTime frameDescription
Change in job satisfaction score14 weeksDifference in job satisfaction questionnaire score.Score between 5 and 25. Higher score= more job satisfaction.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026