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

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.

Study Overview

• Status: Completed
• Conditions: Overweight or Obesity
• Intervention / Treatment: Behavioral: Diet + Activity + Sleep; Behavioral: Diet + Activity

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 9NH
    • Life Course Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diet + Activity + Sleep	Behavioral: Diet + Activity + Sleep; Personalized lifestyle behavior change counselling
Active Comparator: Diet + Activity	Behavioral: Diet + Activity; Personalized lifestyle behavior change counselling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Engagement	Percentage of eligible volunteers consented	14 weeks
Attrition	Percentage drop out	14 weeks
Intervention adherence	Participants complying with intervention.	14 weeks
Intervention adherence - sleep	Sleep hygiene adherence; Scores will range from 0 - 52, with higher scores representing poorer sleep hygiene	14 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body weight	Difference from baseline to post intervention in body weight (kg)	14 weeks
Change in energy and macro nutrient intake	Difference in energy intake (Kcal), and sources of energy (carbohydrates, fats, and protein)	14 weeks
Change in sleep duration	Difference in between baseline and post intervention (hours/night)	14 weeks
Change in physical activity intensity and duration	Difference in activity from MotionWatch (duration hours in vigorous and moderate activity)	14 weeks
Change in sleep quality score	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
Change in work engagement score	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.	14 Weeks
Change in anxiety questionnaire score	Difference in generalized anxiety (GAD-7) questionnaire score.Range 0 to 21. Higher score = higher anxiety level.	14 weeks
Change in depression questionnaire score	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	Difference in Oldenberg Burnout Inventory score, higher score = more burnout signs/symptoms	14 weeks
Change in day time sleepiness	Difference in Epworth Sleepiness Scale. Range 0 to 24 - higher score = more daytime sleepiness	14 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in job satisfaction score	Difference in job satisfaction questionnaire score.Score between 5 and 25. Higher score= more job satisfaction.	14 weeks

Collaborators and Investigators

• Sponsor: King's College London

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2022
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: March 1, 2022
• First Submitted That Met QC Criteria: March 1, 2022
• First Posted (Actual): March 10, 2022

Study Record Updates

• Last Update Posted (Actual): October 10, 2022
• Last Update Submitted That Met QC Criteria: October 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Lifestyle intervention; Employee; Online health and wellbeing
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: KT 2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No