Overweight or ObesityNCT05273892
The KING'S WHOLE Feasibility Study
A study testing Diet + Activity + Sleep and Diet + Activity in people with Overweight or Obesity, run by King's College London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Overweight or Obesity
- What is being tested?
- Diet + Activity + Sleep and Diet + Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Mar 2022to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- - 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.
Trial locations and contacts
1 site in 1 country.
About this 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
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.
Read the 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.
- Conditions
- Overweight or Obesity
- Being tested
- Diet + Activity + Sleep, Diet + Activity
- Keywords
- Employee, Lifestyle intervention, Online health and wellbeing
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet + Activity + SleepBehavioural
Personalized lifestyle behavior change counselling
Diet + ActivityBehavioural
Personalized lifestyle behavior change counselling
| Study group | Role | What they receive |
|---|---|---|
| Diet + Activity + Sleep | Experimental | Not described Receives: Behavioral: Diet + Activity + Sleep |
| Diet + Activity | Active comparator | Not described Receives: Behavioral: Diet + Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement
Percentage of eligible volunteers consented
Measured: 14 weeks
Attrition
Percentage drop out
Measured: 14 weeks
Intervention adherence
Participants complying with intervention.
Measured: 14 weeks
Intervention adherence - sleep
Sleep hygiene adherence; Scores will range from 0 - 52, with higher scores representing poorer sleep hygiene
Measured: 14 weeks
Secondary outcomes (10)
Change in body weight
Difference from baseline to post intervention in body weight (kg)
Measured: 14 weeks
Change in energy and macro nutrient intake
Difference in energy intake (Kcal), and sources of energy (carbohydrates, fats, and protein)
Measured: 14 weeks
Change in sleep duration
Difference in between baseline and post intervention (hours/night)
Measured: 14 weeks
Change in physical activity intensity and duration
Difference in activity from MotionWatch (duration hours in vigorous and moderate activity)
Measured: 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
Measured: 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.
Measured: 14 Weeks
Change in anxiety questionnaire score
Difference in generalized anxiety (GAD-7) questionnaire score.Range 0 to 21. Higher score = higher anxiety level.
Measured: 14 weeks
Change in depression questionnaire score
Difference in PHQ9 depression questionnaire score.Range 0 to 27. Higher score = more likely depressive symptoms.
Measured: 14 weeks
Change in reported level of burn out
Difference in Oldenberg Burnout Inventory score, higher score = more burnout signs/symptoms
Measured: 14 weeks
Change in day time sleepiness
Difference in Epworth Sleepiness Scale. Range 0 to 24 - higher score = more daytime sleepiness
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start7 Mar 2022
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight or ObesityStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05273892
- Sponsor's protocol ID
- KT 2021
- Status last verified
- Mar 2022
- First submitted
- 1 Mar 2022
- Last updated
- 10 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05273892
- Acronym / sponsor ID
- KT 2021
- Conditions
- Overweight or Obesity
- Keywords
- Employee, Lifestyle intervention, Online health and wellbeing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 10 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet + Activity + Sleep | Experimental | Behavioral: Diet + Activity + Sleep |
| Diet + Activity | Active comparator | Behavioral: Diet + Activity |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (2 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet + Activity + SleepPersonalized lifestyle behavior change counselling | Behavioural | Diet + Activity + Sleep |
| Diet + ActivityPersonalized lifestyle behavior change counselling | Behavioural | Diet + Activity |
Primary outcome
Engagement
Time frame: 14 weeks
Percentage of eligible volunteers consented
Attrition
Time frame: 14 weeks
Percentage drop out
Intervention adherence
Time frame: 14 weeks
Participants complying with intervention.
Intervention adherence - sleep
Time frame: 14 weeks
Sleep hygiene adherence; Scores will range from 0 - 52, with higher scores representing poorer sleep hygiene
10 secondary outcomes
Change in body weight
Time frame: 14 weeks
Change in energy and macro nutrient intake
Time frame: 14 weeks
Change in sleep duration
Time frame: 14 weeks
Change in physical activity intensity and duration
Time frame: 14 weeks
Change in sleep quality score
Time frame: 14 Weeks
Change in work engagement score
Time frame: 14 Weeks
Change in anxiety questionnaire score
Time frame: 14 weeks
Change in depression questionnaire score
Time frame: 14 weeks
Change in reported level of burn out
Time frame: 14 weeks
Change in day time sleepiness
Time frame: 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet + Activity + Sleep and Diet + Activity in people with Overweight or Obesity, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement (time frame: 14 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2022.