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

Sponsor
King's College London (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04893772
Collaborator
LighterLife (UK) Ltd (Other)
33
1
6
5.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Intermittent fasting

Study Design

Study Type:
Observational
Actual Enrollment :
33 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Observational Study to Assess Associations Between Daily Meal Timings, Appetite, Mood and Weight Loss in Individuals Completing a Commercial Intermittent Fasting Programme
Actual Study Start Date :
Jun 30, 2021
Anticipated Primary Completion Date :
Oct 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Outcome Measures

Primary Outcome Measures

  1. Body weight in kg [Change in body weight up to 12 weeks]

    Weighed at home

Secondary Outcome Measures

  1. Sleep duration [Before weight loss programme (day 0)]

    Pittsburg Sleep Quality Index (PSQI) questionnaire

  2. Sleep quality [Before weight loss programme (day 0)]

    Pittsburg Sleep Quality Index (PSQI) questionnaire

  3. Physical activity [Before weight loss programme (day 0)]

    Simple Physical Activity Questionnaire (SIMPAQ)

  4. Meal timings [Before weight loss programme (day 0)]

    Meal timings questionnaire

  5. How hungry do you feel? [Daily from day 1 up to 12 weeks]

    Visual Analogue Scales, scale of 0 (I am not hungry at all) -100 (I have never been more hungry)

  6. How satisfied do you feel? [Daily from day 1 up to 12 weeks]

    Visual Analogue Scales, scale of 0 (I am completely empty) -100 (I cannot eat another bite)

  7. How full do you feel? [Daily from day 1 up to 12 weeks]

    Visual Analogue Scales, scale of 0 (not at all) -100 (totally full)

  8. How much do you think you can eat? [Daily from day 1 up to 12 weeks]

    Visual Analogue Scales, scale of 0 (nothing at all) -100 (a lot)

  9. Would you like to eat something sweet? [Daily from day 1 up to 12 weeks]

    Visual Analogue Scales, scale of 0 (yes very much) -100 (not at all)

  10. Would you like to eat something salty? [Daily from day 1 up to 12 weeks]

    Visual Analogue Scales, scale of 0 (yes very much) -100 (not at all)

  11. Would you like to eat something savoury? [Daily from day 1 up to 12 weeks]

    Visual Analogue Scales, scale of 0 (yes very much) -100 (not at all)

  12. Would you like to eat something fatty? [Daily from day 1 up to 12 weeks]

    Visual Analogue Scales, scale of 0 (yes very much) -100 (not at all)

  13. Overall my mood is (very unpleasant to very pleasant) [Daily from day 1 up to 12 weeks]

    Brief Mood Introspection Scale (BMIS), scale -10 to 10

  14. Mindfulness - I was finding to difficult to stay focused on what I was doing [Weekly from week 1 up to 12 weeks]

    Mindful Attention Awareness Scale (MASS), scale 0 (not at all) to 6 (very much)

  15. Mindfulness - I was doing something without paying attention [Weekly from week 1 up to 12 weeks]

    Mindful Attention Awareness Scale (MASS), scale 0 (not at all) to 6 (very much)

  16. Mindfulness - I was preoccupied with the future or the past [Weekly from week 1 up to 12 weeks]

    Mindful Attention Awareness Scale (MASS), scale 0 (not at all) to 6 (very much)

  17. Mindfulness - I was doing something automatically without being aware of what I was doing [Weekly from week 1 up to 12 weeks]

    Mindful Attention Awareness Scale (MASS), scale 0 (not at all) to 6 (very much)

  18. Mindfulness - I was rushing through something without really being attentive to it. [Weekly from week 1 up to 12 weeks]

    Mindful Attention Awareness Scale (MASS), scale 0 (not at all) to 6 (very much)

  19. Height [Before weight loss programme (day 0)]

    Height in cm

  20. Dietary intake (macronutrients and energy) [Before weight loss programme (day 0)]

    24 h recall x 2

  21. Diet quality [Before weight loss programme (day 0)]

    24 h recall x 2

  22. Dietary intake (macronutrients and energy) [Non-fasting days: Weeks 1, 2, 3, 4, 8 and 12]

    24 h recall x 4 (4 non-fasting days)

  23. Diet quality [Non-fasting days: Weeks 1, 2, 3, 4, 8 and 12]

    24 h recall x 4 (4 non-fasting days)

  24. Meal replacement product choice [Fasting days: Weeks 1, 2, 3, 4, 8 and 12]

    Question: Which meal replacement products did you consume?

  25. Meal replacement product timings [Fasting days: Weeks 1, 2, 3, 4, 8 and 12]

    Question: What time did you consume the meal replacement products?

  26. Sleep duration [Daily from day 1 up to 12 weeks]

    Question: How long did you sleep?

  27. Sleep quality [Daily from day 1 up to 12 weeks]

    Questions to rate quality of sleep

  28. Physical activity [Daily from day 1 up to 12 weeks]

    Question: Did you do any structured exercise today?

  29. Alcohol use [Before weight loss programme (day 0)]

    AUDIT questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Nutritional Sciences, King's College London London United Kingdom

Sponsors and Collaborators

  • King's College London
  • LighterLife (UK) Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
King's College London
ClinicalTrials.gov Identifier:
NCT04893772
Other Study ID Numbers:
  • DASMA_KCL
First Posted:
May 20, 2021
Last Update Posted:
Aug 2, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 2, 2021