The KING'S WHOLE Feasibility Study

Overweight or Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05273892
• Other study ID #: KT 2021
• Status: Completed
• Phase: N/A
• Start date: March 7, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: March 2022
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Overweight
• Overweight or Obesity

Intervention

Behavioral:
• Diet + Activity + Sleep
Personalized lifestyle behavior change counselling
• Diet + Activity
Personalized lifestyle behavior change counselling

Locations

Country	Name	City	State
United Kingdom	Life Course Sciences	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in job satisfaction score	Difference in job satisfaction questionnaire score.Score between 5 and 25. Higher score= more job satisfaction.	14 weeks
Primary	Engagement	Percentage of eligible volunteers consented	14 weeks
Primary	Attrition	Percentage drop out	14 weeks
Primary	Intervention adherence	Participants complying with intervention.	14 weeks
Primary	Intervention adherence - sleep	Sleep hygiene adherence; Scores will range from 0 - 52, with higher scores representing poorer sleep hygiene	14 weeks
Secondary	Change in body weight	Difference from baseline to post intervention in body weight (kg)	14 weeks
Secondary	Change in energy and macro nutrient intake	Difference in energy intake (Kcal), and sources of energy (carbohydrates, fats, and protein)	14 weeks
Secondary	Change in sleep duration	Difference in between baseline and post intervention (hours/night)	14 weeks
Secondary	Change in physical activity intensity and duration	Difference in activity from MotionWatch (duration hours in vigorous and moderate activity)	14 weeks
Secondary	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
Secondary	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
Secondary	Change in anxiety questionnaire score	Difference in generalized anxiety (GAD-7) questionnaire score.Range 0 to 21. Higher score = higher anxiety level.	14 weeks
Secondary	Change in depression questionnaire score	Difference in PHQ9 depression questionnaire score.Range 0 to 27. Higher score = more likely depressive symptoms.	14 weeks
Secondary	Change in reported level of burn out	Difference in Oldenberg Burnout Inventory score, higher score = more burnout signs/symptoms	14 weeks
Secondary	Change in day time sleepiness	Difference in Epworth Sleepiness Scale. Range 0 to 24 - higher score = more daytime sleepiness	14 weeks