Clinical trial NCT04893772: Meal Timings, Appetite, Mood and Weight Loss in Individuals on a Commercial Intermittent Fasting Programme
Official title: Observational Study to Assess Associations Between Daily Meal Timings, Appetite, Mood and Weight Loss in Individuals Completing a Commercial Intermittent Fasting Programme
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Weight Loss
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: LighterLife (UK) Ltd
First posted: 2021-05-20
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults embarking on a commerical intermittent fasting weight loss programme

Brief summary: Although individuals following commercial intermittent fasting programmes consume meal replacement products during fasting days, further behavioural variables such as time of food consumption, sleep quality and duration, appetite and mood may significantly impact weight loss and intervention success. This project aims to assess behavioural patterns (dietary intake, sleep, meal timing, physical activity), mood and appetite on both fasting and non-fasting days and to investigate whether these are associated with weight loss.


Eligibility criteria: Inclusion Criteria:

* Those responding to adverts on the LighterLife Fast Challenge social media channels will be asked if they would like to participate

Exclusion Criteria:

* Those without access to a smart phone or laptop will not be eligible to take part in the study due to the need to report variables daily

Primary outcomes:
measure: Body weight in kg
timeFrame: Change in body weight up to 12 weeks
Secondary outcomes:
measure: Sleep duration
timeFrame: Before weight loss programme (day 0)
measure: Sleep quality
timeFrame: Before weight loss programme (day 0)
measure: Physical activity
timeFrame: Before weight loss programme (day 0)
measure: Meal timings
timeFrame: Before weight loss programme (day 0)
measure: How hungry do you feel?
timeFrame: Daily from day 1 up to 12 weeks
measure: How satisfied do you feel?
timeFrame: Daily from day 1 up to 12 weeks
measure: How full do you feel?
timeFrame: Daily from day 1 up to 12 weeks
measure: How much do you think you can eat?
timeFrame: Daily from day 1 up to 12 weeks
measure: Would you like to eat something sweet?
timeFrame: Daily from day 1 up to 12 weeks
measure: Would you like to eat something salty?
timeFrame: Daily from day 1 up to 12 weeks
measure: Would you like to eat something savoury?
timeFrame: Daily from day 1 up to 12 weeks
measure: Would you like to eat something fatty?
timeFrame: Daily from day 1 up to 12 weeks
measure: Overall my mood is (very unpleasant to very pleasant)
timeFrame: Daily from day 1 up to 12 weeks
measure: Mindfulness - I was finding to difficult to stay focused on what I was doing
timeFrame: Weekly from week 1 up to 12 weeks
measure: Mindfulness - I was doing something without paying attention
timeFrame: Weekly from week 1 up to 12 weeks
measure: Mindfulness - I was preoccupied with the future or the past
timeFrame: Weekly from week 1 up to 12 weeks
measure: Mindfulness - I was doing something automatically without being aware of what I was doing
timeFrame: Weekly from week 1 up to 12 weeks
measure: Mindfulness - I was rushing through something without really being attentive to it.
timeFrame: Weekly from week 1 up to 12 weeks
measure: Height
timeFrame: Before weight loss programme (day 0)
measure: Dietary intake (macronutrients and energy)
timeFrame: Before weight loss programme (day 0)
measure: Diet quality
timeFrame: Before weight loss programme (day 0)
measure: Dietary intake (macronutrients and energy)
timeFrame: Non-fasting days: Weeks 1, 2, 3, 4, 8 and 12
measure: Diet quality
timeFrame: Non-fasting days: Weeks 1, 2, 3, 4, 8 and 12
measure: Meal replacement product choice
timeFrame: Fasting days: Weeks 1, 2, 3, 4, 8 and 12
measure: Meal replacement product timings
timeFrame: Fasting days: Weeks 1, 2, 3, 4, 8 and 12
measure: Sleep duration
timeFrame: Daily from day 1 up to 12 weeks
measure: Sleep quality
timeFrame: Daily from day 1 up to 12 weeks
measure: Physical activity
timeFrame: Daily from day 1 up to 12 weeks
measure: Alcohol use
timeFrame: Before weight loss programme (day 0)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Department of Nutritional Sciences, King's College London
Study officials:
References: