Clinical trial NCT05273892: The KING'S WHOLE Feasibility Study
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight or Obesity
Keywords: Employee
Lifestyle intervention
Online health and wellbeing
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Engagement
timeFrame: 14 weeks
measure: Attrition
timeFrame: 14 weeks
measure: Intervention adherence
timeFrame: 14 weeks
measure: Intervention adherence - sleep
timeFrame: 14 weeks
Secondary outcomes:
measure: Change in body weight
timeFrame: 14 weeks
measure: Change in energy and macro nutrient intake
timeFrame: 14 weeks
measure: Change in sleep duration
timeFrame: 14 weeks
measure: Change in physical activity intensity and duration
timeFrame: 14 weeks
measure: Change in sleep quality score
timeFrame: 14 Weeks
measure: Change in work engagement score
timeFrame: 14 Weeks
measure: Change in anxiety questionnaire score
timeFrame: 14 weeks
measure: Change in depression questionnaire score
timeFrame: 14 weeks
measure: Change in reported level of burn out
timeFrame: 14 weeks
measure: Change in day time sleepiness
timeFrame: 14 weeks
Other outcomes:
measure: Change in job satisfaction score
timeFrame: 14 weeks
Locations:
city: London
country: United Kingdom
facility: Life Course Sciences
Study officials:
References: