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

Study Overview
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Brief Summary
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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.

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

Conditions
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Weight Loss

Intervention / Treatment
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* Dietary Supplement: Intermittent fasting


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Intermittent fasting|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.|

What is the study measuring?
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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) |