NCT05273892

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

March 7, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 10, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

October 10, 2022

Status Verified

March 1, 2022

Enrollment Period

7 months

First QC Date

March 1, 2022

Last Update Submit

October 7, 2022

Conditions

Overweight or Obesity

Keywords

EmployeeLifestyle interventionOnline health and wellbeing

Outcome Measures

Primary Outcomes (4)

  • Engagement

    Percentage of eligible volunteers consented

    14 weeks

  • Attrition

    Percentage drop out

    14 weeks

  • Intervention adherence

    Participants complying with intervention.

    14 weeks

  • Intervention adherence - sleep

    Sleep hygiene adherence; Scores will range from 0 - 52, with higher scores representing poorer sleep hygiene

    14 weeks

Secondary Outcomes (10)

  • Change in body weight

    14 weeks

  • Change in energy and macro nutrient intake

    14 weeks

  • Change in sleep duration

    14 weeks

  • Change in physical activity intensity and duration

    14 weeks

  • Change in sleep quality score

    14 Weeks

  • +5 more secondary outcomes

Other Outcomes (1)

  • Change in job satisfaction score

    14 weeks

Study Arms (2)

Diet + Activity + Sleep

EXPERIMENTAL
Behavioral: Diet + Activity + Sleep

Diet + Activity

ACTIVE COMPARATOR
Behavioral: Diet + Activity

Interventions

Diet + Activity + SleepBEHAVIORAL

Personalized lifestyle behavior change counselling

Diet + Activity + Sleep
Diet + ActivityBEHAVIORAL

Personalized lifestyle behavior change counselling

Diet + Activity

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Life Course Sciences

London, SE1 9NH, United Kingdom

Location

MeSH Terms

Conditions

OverweightObesity

Interventions

DietExerciseSleep

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaNervous System Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2022

First Posted

March 10, 2022

Study Start

March 7, 2022

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

October 10, 2022

Record last verified: 2022-03

Locations

GB(1)