Meal Timings, Appetite, Mood and Weight Loss in Individuals on a Commercial Intermittent Fasting Programme (DASMA)

Observational Study to Assess Associations Between Daily Meal Timings, Appetite, Mood and Weight Loss in Individuals Completing a Commercial Intermittent Fasting Programme

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.

Study Overview

• Status: Completed
• Conditions: Weight Loss
• Intervention / Treatment: Dietary supplement: Intermittent fasting

• Study Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Department of Nutritional Sciences, King's College London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adults embarking on a commerical intermittent fasting weight loss programme

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight in kg	Weighed at home	Change in body weight up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep duration	Pittsburg Sleep Quality Index (PSQI) questionnaire	Before weight loss programme (day 0)
Sleep quality	Pittsburg Sleep Quality Index (PSQI) questionnaire	Before weight loss programme (day 0)
Physical activity	Simple Physical Activity Questionnaire (SIMPAQ)	Before weight loss programme (day 0)
Meal timings	Meal timings questionnaire	Before weight loss programme (day 0)
How hungry do you feel?	Visual Analogue Scales, scale of 0 (I am not hungry at all) -100 (I have never been more hungry)	Daily from day 1 up to 12 weeks
How satisfied do you feel?	Visual Analogue Scales, scale of 0 (I am completely empty) -100 (I cannot eat another bite)	Daily from day 1 up to 12 weeks
How full do you feel?	Visual Analogue Scales, scale of 0 (not at all) -100 (totally full)	Daily from day 1 up to 12 weeks
How much do you think you can eat?	Visual Analogue Scales, scale of 0 (nothing at all) -100 (a lot)	Daily from day 1 up to 12 weeks
Would you like to eat something sweet?	Visual Analogue Scales, scale of 0 (yes very much) -100 (not at all)	Daily from day 1 up to 12 weeks
Would you like to eat something salty?	Visual Analogue Scales, scale of 0 (yes very much) -100 (not at all)	Daily from day 1 up to 12 weeks
Would you like to eat something savoury?	Visual Analogue Scales, scale of 0 (yes very much) -100 (not at all)	Daily from day 1 up to 12 weeks
Would you like to eat something fatty?	Visual Analogue Scales, scale of 0 (yes very much) -100 (not at all)	Daily from day 1 up to 12 weeks
Overall my mood is (very unpleasant to very pleasant)	Brief Mood Introspection Scale (BMIS), scale -10 to 10	Daily from day 1 up to 12 weeks
Mindfulness - I was finding to difficult to stay focused on what I was doing	Mindful Attention Awareness Scale (MASS), scale 0 (not at all) to 6 (very much)	Weekly from week 1 up to 12 weeks
Mindfulness - I was doing something without paying attention	Mindful Attention Awareness Scale (MASS), scale 0 (not at all) to 6 (very much)	Weekly from week 1 up to 12 weeks
Mindfulness - I was preoccupied with the future or the past	Mindful Attention Awareness Scale (MASS), scale 0 (not at all) to 6 (very much)	Weekly from week 1 up to 12 weeks
Mindfulness - I was doing something automatically without being aware of what I was doing	Mindful Attention Awareness Scale (MASS), scale 0 (not at all) to 6 (very much)	Weekly from week 1 up to 12 weeks
Mindfulness - I was rushing through something without really being attentive to it.	Mindful Attention Awareness Scale (MASS), scale 0 (not at all) to 6 (very much)	Weekly from week 1 up to 12 weeks
Height	Height in cm	Before weight loss programme (day 0)
Dietary intake (macronutrients and energy)	24 h recall x 2	Before weight loss programme (day 0)
Diet quality	24 h recall x 2	Before weight loss programme (day 0)
Dietary intake (macronutrients and energy)	24 h recall x 4 (4 non-fasting days)	Non-fasting days: Weeks 1, 2, 3, 4, 8 and 12
Diet quality	24 h recall x 4 (4 non-fasting days)	Non-fasting days: Weeks 1, 2, 3, 4, 8 and 12
Meal replacement product choice	Question: Which meal replacement products did you consume?	Fasting days: Weeks 1, 2, 3, 4, 8 and 12
Meal replacement product timings	Question: What time did you consume the meal replacement products?	Fasting days: Weeks 1, 2, 3, 4, 8 and 12
Sleep duration	Question: How long did you sleep?	Daily from day 1 up to 12 weeks
Sleep quality	Questions to rate quality of sleep	Daily from day 1 up to 12 weeks
Physical activity	Question: Did you do any structured exercise today?	Daily from day 1 up to 12 weeks
Alcohol use	AUDIT questionnaire	Before weight loss programme (day 0)

Collaborators and Investigators

• Sponsor: King's College London
• Collaborators: LighterLife (UK) Ltd

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2021
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: May 12, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (Actual): May 20, 2021

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 18, 2023
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: DASMA_KCL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No