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

April 18, 2023 updated by: King's College London

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Body weight in kg
Time Frame: Change in body weight up to 12 weeks
Weighed at home
Change in body weight up to 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sleep duration
Time Frame: Before weight loss programme (day 0)
Pittsburg Sleep Quality Index (PSQI) questionnaire
Before weight loss programme (day 0)
Sleep quality
Time Frame: Before weight loss programme (day 0)
Pittsburg Sleep Quality Index (PSQI) questionnaire
Before weight loss programme (day 0)
Physical activity
Time Frame: Before weight loss programme (day 0)
Simple Physical Activity Questionnaire (SIMPAQ)
Before weight loss programme (day 0)
Meal timings
Time Frame: Before weight loss programme (day 0)
Meal timings questionnaire
Before weight loss programme (day 0)
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)
Daily from day 1 up to 12 weeks
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)
Daily from day 1 up to 12 weeks
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)
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
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?
Time Frame: Daily from day 1 up to 12 weeks
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?
Time Frame: Daily from day 1 up to 12 weeks
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?
Time Frame: Daily from day 1 up to 12 weeks
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?
Time Frame: Daily from day 1 up to 12 weeks
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)
Time Frame: Daily from day 1 up to 12 weeks
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
Time Frame: Weekly from week 1 up to 12 weeks
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
Time Frame: Weekly from week 1 up to 12 weeks
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
Time Frame: Weekly from week 1 up to 12 weeks
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
Time Frame: Weekly from week 1 up to 12 weeks
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.
Time Frame: Weekly from week 1 up to 12 weeks
Mindful Attention Awareness Scale (MASS), scale 0 (not at all) to 6 (very much)
Weekly from week 1 up to 12 weeks
Height
Time Frame: Before weight loss programme (day 0)
Height in cm
Before weight loss programme (day 0)
Dietary intake (macronutrients and energy)
Time Frame: Before weight loss programme (day 0)
24 h recall x 2
Before weight loss programme (day 0)
Diet quality
Time Frame: Before weight loss programme (day 0)
24 h recall x 2
Before weight loss programme (day 0)
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)
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
24 h recall x 4 (4 non-fasting days)
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
Question: Which meal replacement products did you consume?
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
Question: What time did you consume the meal replacement products?
Fasting days: Weeks 1, 2, 3, 4, 8 and 12
Sleep duration
Time Frame: Daily from day 1 up to 12 weeks
Question: How long did you sleep?
Daily from day 1 up to 12 weeks
Sleep quality
Time Frame: Daily from day 1 up to 12 weeks
Questions to rate quality of sleep
Daily from day 1 up to 12 weeks
Physical activity
Time Frame: Daily from day 1 up to 12 weeks
Question: Did you do any structured exercise today?
Daily from day 1 up to 12 weeks
Alcohol use
Time Frame: Before weight loss programme (day 0)
AUDIT questionnaire
Before weight loss programme (day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
King's College London

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
LighterLife (UK) Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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