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The KING'S WHOLE Feasibility Study

Primary Purpose

Overweight or Obesity

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Diet + Activity + Sleep
Diet + Activity
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight or Obesity focused on measuring Employee, Lifestyle intervention, Online health and wellbeing

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Life Course Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Diet + Activity + Sleep

Diet + Activity

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 1, 2022
Last Updated
October 7, 2022
Sponsor
King's College London
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1. Study Identification

Unique Protocol Identification Number
NCT05273892
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 7, 2022 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight or Obesity
Keywords
Employee, Lifestyle intervention, Online health and wellbeing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diet + Activity + Sleep
Arm Type
Experimental
Arm Title
Diet + Activity
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Diet + Activity + Sleep
Intervention Description
Personalized lifestyle behavior change counselling
Intervention Type
Behavioral
Intervention Name(s)
Diet + Activity
Intervention Description
Personalized lifestyle behavior change counselling
Primary Outcome Measure Information:
Title
Engagement
Description
Percentage of eligible volunteers consented
Time Frame
14 weeks
Title
Attrition
Description
Percentage drop out
Time Frame
14 weeks
Title
Intervention adherence
Description
Participants complying with intervention.
Time Frame
14 weeks
Title
Intervention adherence - sleep
Description
Sleep hygiene adherence; Scores will range from 0 - 52, with higher scores representing poorer sleep hygiene
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Change in body weight
Description
Difference from baseline to post intervention in body weight (kg)
Time Frame
14 weeks
Title
Change in energy and macro nutrient intake
Description
Difference in energy intake (Kcal), and sources of energy (carbohydrates, fats, and protein)
Time Frame
14 weeks
Title
Change in sleep duration
Description
Difference in between baseline and post intervention (hours/night)
Time Frame
14 weeks
Title
Change in physical activity intensity and duration
Description
Difference in activity from MotionWatch (duration hours in vigorous and moderate activity)
Time Frame
14 weeks
Title
Change in sleep quality score
Description
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
Time Frame
14 Weeks
Title
Change in work engagement score
Description
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.
Time Frame
14 Weeks
Title
Change in anxiety questionnaire score
Description
Difference in generalized anxiety (GAD-7) questionnaire score.Range 0 to 21. Higher score = higher anxiety level.
Time Frame
14 weeks
Title
Change in depression questionnaire score
Description
Difference in PHQ9 depression questionnaire score.Range 0 to 27. Higher score = more likely depressive symptoms.
Time Frame
14 weeks
Title
Change in reported level of burn out
Description
Difference in Oldenberg Burnout Inventory score, higher score = more burnout signs/symptoms
Time Frame
14 weeks
Title
Change in day time sleepiness
Description
Difference in Epworth Sleepiness Scale. Range 0 to 24 - higher score = more daytime sleepiness
Time Frame
14 weeks
Other Pre-specified Outcome Measures:
Title
Change in job satisfaction score
Description
Difference in job satisfaction questionnaire score.Score between 5 and 25. Higher score= more job satisfaction.
Time Frame
14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Life Course Sciences
City
London
ZIP/Postal Code
SE1 9NH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The KING'S WHOLE Feasibility Study

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