Weight LossDASMANCT04893772
Meal Timings, Appetite, Mood and Weight Loss in Individuals on a Commercial Intermittent Fasting Programme
An observational study of Weight Loss, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- Intermittent fasting
- How many people
- 33 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Jun 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults embarking on a commerical intermittent fasting weight loss programme
Who may be able to join
- Those responding to adverts on the LighterLife Fast Challenge social media channels will be asked if they would like to participate
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Nutritional Sciences, King's College London
London
About this study
Official title: 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.
- Conditions
- Weight Loss
- Being tested
- Intermittent fasting
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent fastingDietary supplement
Also called LighterLife Fast
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 being measured
The primary outcome is the main question the study is designed to answer.
Body weight in kg
Weighed at home
Measured: Change in body weight up to 12 weeks
Secondary outcomes (29)
Sleep duration
Pittsburg Sleep Quality Index (PSQI) questionnaire
Measured: Before weight loss programme (day 0)
Sleep quality
Pittsburg Sleep Quality Index (PSQI) questionnaire
Measured: Before weight loss programme (day 0)
Physical activity
Simple Physical Activity Questionnaire (SIMPAQ)
Measured: Before weight loss programme (day 0)
Meal timings
Meal timings questionnaire
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Weekly from week 1 up to 12 weeks
Height
Height in cm
Measured: Before weight loss programme (day 0)
Dietary intake (macronutrients and energy)
24 h recall x 2
Measured: Before weight loss programme (day 0)
Diet quality
24 h recall x 2
Measured: Before weight loss programme (day 0)
Dietary intake (macronutrients and energy)
24 h recall x 4 (4 non-fasting days)
Measured: Non-fasting days: Weeks 1, 2, 3, 4, 8 and 12
Diet quality
24 h recall x 4 (4 non-fasting days)
Measured: Non-fasting days: Weeks 1, 2, 3, 4, 8 and 12
Meal replacement product choice
Question: Which meal replacement products did you consume?
Measured: Fasting days: Weeks 1, 2, 3, 4, 8 and 12
Meal replacement product timings
Question: What time did you consume the meal replacement products?
Measured: Fasting days: Weeks 1, 2, 3, 4, 8 and 12
Sleep duration
Question: How long did you sleep?
Measured: Daily from day 1 up to 12 weeks
Sleep quality
Questions to rate quality of sleep
Measured: Daily from day 1 up to 12 weeks
Physical activity
Question: Did you do any structured exercise today?
Measured: Daily from day 1 up to 12 weeks
Alcohol use
AUDIT questionnaire
Measured: Before weight loss programme (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start30 Jun 2021
- Primary completion31 Oct 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- LighterLife (UK) Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04893772
- Sponsor's protocol ID
- DASMA_KCL
- Acronym
- DASMA
- Status last verified
- May 2021
- First submitted
- 12 May 2021
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Assess Associations Between Daily Meal Timings, Appetite, Mood and Weight Loss in Individuals Completing a Commercial Intermittent Fasting Programme
- ClinicalTrials.gov ID
- NCT04893772
- Acronym / sponsor ID
- DASMA / DASMA_KCL
- Conditions
- Weight Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- LighterLife (UK) Ltd
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 20 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults embarking on a commerical intermittent fasting weight loss programme
Key inclusion criteria (1 listed)
- Those responding to adverts on the LighterLife Fast Challenge social media channels will be asked if they would like to participate
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent fastingAlso: LighterLife FastThree "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. | Dietary supplement | – |
Primary outcome
Body weight in kg
Time frame: Change in body weight up to 12 weeks
Weighed at home
29 secondary outcomes
Sleep duration
Time frame: Before weight loss programme (day 0)
Sleep quality
Time frame: Before weight loss programme (day 0)
Physical activity
Time frame: Before weight loss programme (day 0)
Meal timings
Time frame: Before weight loss programme (day 0)
How hungry do you feel?
Time frame: Daily from day 1 up to 12 weeks
How satisfied do you feel?
Time frame: Daily from day 1 up to 12 weeks
How full do you feel?
Time frame: Daily from day 1 up to 12 weeks
How much do you think you can eat?
Time frame: Daily from day 1 up to 12 weeks
Would you like to eat something sweet?
Time frame: Daily from day 1 up to 12 weeks
Would you like to eat something salty?
Time frame: Daily from day 1 up to 12 weeks
Would you like to eat something savoury?
Time frame: Daily from day 1 up to 12 weeks
Would you like to eat something fatty?
Time frame: Daily from day 1 up to 12 weeks
Overall my mood is (very unpleasant to very pleasant)
Time frame: Daily from day 1 up to 12 weeks
Mindfulness - I was finding to difficult to stay focused on what I was doing
Time frame: Weekly from week 1 up to 12 weeks
Mindfulness - I was doing something without paying attention
Time frame: Weekly from week 1 up to 12 weeks
Mindfulness - I was preoccupied with the future or the past
Time frame: Weekly from week 1 up to 12 weeks
Mindfulness - I was doing something automatically without being aware of what I was doing
Time frame: Weekly from week 1 up to 12 weeks
Mindfulness - I was rushing through something without really being attentive to it.
Time frame: Weekly from week 1 up to 12 weeks
Height
Time frame: Before weight loss programme (day 0)
Dietary intake (macronutrients and energy)
Time frame: Before weight loss programme (day 0)
Diet quality
Time frame: Before weight loss programme (day 0)
Dietary intake (macronutrients and energy)
Time frame: Non-fasting days: Weeks 1, 2, 3, 4, 8 and 12
Diet quality
Time frame: Non-fasting days: Weeks 1, 2, 3, 4, 8 and 12
Meal replacement product choice
Time frame: Fasting days: Weeks 1, 2, 3, 4, 8 and 12
Meal replacement product timings
Time frame: Fasting days: Weeks 1, 2, 3, 4, 8 and 12
Sleep duration
Time frame: Daily from day 1 up to 12 weeks
Sleep quality
Time frame: Daily from day 1 up to 12 weeks
Physical activity
Time frame: Daily from day 1 up to 12 weeks
Alcohol use
Time frame: Before weight loss programme (day 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weight Loss, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight in kg (time frame: Change in body weight up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.