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OpenTrials
Completed

NCT Number: NCT04893772

Meal Timings, Appetite, Mood and Weight Loss in Individuals on 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.

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Key information

Conditions

Weight Loss Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Nutritional Sciences, King's College London

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intermittent fasting

Dietary Supplement

Three "fasting" days a week, whereby participants consume 600-800 kcal/day from 4 meal replacement products: breakfast, lunch, a snack and dinner. During the other 4 non-fasting "smart" days each week, participants are instructed to consume 2 x 300 kcal meals and 2 x 100 kcal snacks, from a selection of recipes, plus one meal of their own choosing.

Other names: LighterLife Fast

Primary outcomes

  1. Body weight in kg

    Time frame: Change in body weight up to 12 weeks

    Weighed at home

Secondary outcomes

  1. Sleep duration

    Time frame: Before weight loss programme (day 0)

    Pittsburg Sleep Quality Index (PSQI) questionnaire

  2. Sleep quality

    Time frame: Before weight loss programme (day 0)

    Pittsburg Sleep Quality Index (PSQI) questionnaire

  3. Physical activity

    Time frame: Before weight loss programme (day 0)

    Simple Physical Activity Questionnaire (SIMPAQ)

  4. Meal timings

    Time frame: Before weight loss programme (day 0)

    Meal timings questionnaire

  5. How hungry do you feel?

    Time frame: 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?

    Time frame: 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?

    Time frame: 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?

    Time frame: 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?

    Time frame: 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?

    Time frame: 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?

    Time frame: 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?

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

    Time frame: Weekly from week 1 up to 12 weeks

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

  19. Height

    Time frame: Before weight loss programme (day 0)

    Height in cm

  20. Dietary intake (macronutrients and energy)

    Time frame: Before weight loss programme (day 0)

    24 h recall x 2

  21. Diet quality

    Time frame: Before weight loss programme (day 0)

    24 h recall x 2

  22. Dietary intake (macronutrients and energy)

    Time frame: Non-fasting days: Weeks 1, 2, 3, 4, 8 and 12

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

  23. Diet quality

    Time frame: 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

    Time frame: Fasting days: Weeks 1, 2, 3, 4, 8 and 12

    Question: Which meal replacement products did you consume?

  25. Meal replacement product timings

    Time frame: Fasting days: Weeks 1, 2, 3, 4, 8 and 12

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

  26. Sleep duration

    Time frame: Daily from day 1 up to 12 weeks

    Question: How long did you sleep?

  27. Sleep quality

    Time frame: Daily from day 1 up to 12 weeks

    Questions to rate quality of sleep

  28. Physical activity

    Time frame: Daily from day 1 up to 12 weeks

    Question: Did you do any structured exercise today?

  29. Alcohol use

    Time frame: Before weight loss programme (day 0)

    AUDIT questionnaire

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

  • LighterLife (UK) Ltd

Registry information

Official study title

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

Acronym: DASMA

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 20, 2021
Registry last updated
Apr 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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