NCT04893772

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 20, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

June 30, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 19, 2023

Status Verified

May 1, 2021

Enrollment Period

4 months

First QC Date

May 12, 2021

Last Update Submit

April 18, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Body weight in kg

    Weighed at home

    Change in body weight up to 12 weeks

Secondary Outcomes (29)

  • Sleep duration

    Before weight loss programme (day 0)

  • Sleep quality

    Before weight loss programme (day 0)

  • Physical activity

    Before weight loss programme (day 0)

  • Meal timings

    Before weight loss programme (day 0)

  • How hungry do you feel?

    Daily from day 1 up to 12 weeks

  • +24 more secondary outcomes

Interventions

Intermittent fastingDIETARY_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.

Also known as: LighterLife Fast

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults embarking on a commerical intermittent fasting weight loss programme

You may qualify if:

  • Those responding to adverts on the LighterLife Fast Challenge social media channels will be asked if they would like to participate

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nutritional Sciences, King's College London

London, United Kingdom

Location

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2021

First Posted

May 20, 2021

Study Start

June 30, 2021

Primary Completion

October 31, 2021

Study Completion

December 31, 2021

Last Updated

April 19, 2023

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations