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The KING'S WHOLE Feasibility Study

7. oktober 2022 opdateret af: King's College London

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

28

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Diet + Activity + Sleep
Adfærdsmæssigt: Diet + Activity + Sleep
Personalized lifestyle behavior change counselling
Aktiv komparator: Diet + Activity
Adfærdsmæssigt: Diet + Activity
Personalized lifestyle behavior change counselling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Engagement
Tidsramme: 14 weeks
Percentage of eligible volunteers consented
14 weeks
Attrition
Tidsramme: 14 weeks
Percentage drop out
14 weeks
Intervention adherence
Tidsramme: 14 weeks
Participants complying with intervention.
14 weeks
Intervention adherence - sleep
Tidsramme: 14 weeks
Sleep hygiene adherence; Scores will range from 0 - 52, with higher scores representing poorer sleep hygiene
14 weeks

Sekundære resultatmål

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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in job satisfaction score
Tidsramme: 14 weeks
Difference in job satisfaction questionnaire score.Score between 5 and 25. Higher score= more job satisfaction.
14 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

King's College London

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

7. marts 2022

Primær færdiggørelse (Faktiske)

30. september 2022

Studieafslutning (Faktiske)

30. september 2022

Datoer for studieregistrering

Først indsendt

1. marts 2022

Først indsendt, der opfyldte QC-kriterier

1. marts 2022

Først opslået (Faktiske)

10. marts 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. oktober 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. oktober 2022

Sidst verificeret

1. marts 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KT 2021

Plan for individuelle deltagerdata (IPD)

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