Study of Eating Patterns with a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome
3 other identifiers
interventional
235
1 country
2
Brief Summary
SwissChronoFood - Study of eating patterns with a smartphone app and the metabolic effects of time restricted feeding in metabolic syndrome The purpose of this study is to assess eating patterns among teenagers and adults with a new method, going beyond the pen-and-paper food diaries, and to investigate whether time restricted feeding leads to weight loss, improvement in lipid and glucose metabolism in individuals with components of the metabolic syndrome
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2017
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2017
CompletedFirst Posted
Study publicly available on registry
August 7, 2017
CompletedStudy Start
First participant enrolled
September 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2022
CompletedDecember 6, 2024
August 1, 2024
3.5 years
April 2, 2017
December 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Eating duration
Duration from the first to last caloric intake over 24-hour cycle, collected via the smartphone app. Note: Key inclusion criterion for the intervention phase (Part 2).
From baseline visit to end of observation phase (Part 1: 4 weeks for adults, 2 weeks for teenagers)
Change of metabolic syndrome components
Number of participants with changes in weight and/or lipid profile and/or glucose metabolism in the intervention phase (Part 2). Note: Changes of the different components will be analyzed separately as secondary outcomes.
From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)
Secondary Outcomes (11)
Adherence to TRF intervention
From randomization visit to close-out visit (Part 2: 6 months for adults, 6 weeks for teenagers)
Weight change
From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)
Change in lipid profile
From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)
Change in glucose metabolism
From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)
Change in blood pressure
From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers)
- +6 more secondary outcomes
Other Outcomes (7)
Change in fat mass
From randomization visit to close-out visit (Part 3: 6 months, only adults)
Change in fat free mass
From randomization visit to close-out visit (Part 3: 6 months, only adults)
Change in diurnal rhythms of cortisol secretion
From randomization visit to close-out visit (Part 3: 6 months, only adults)
- +4 more other outcomes
Study Arms (2)
Time restricted feeding
EXPERIMENTALFor those in the intervention phase (Part 2)
Regular dietary advices
ACTIVE COMPARATORFor those in the intervention phase (Part 2)
Interventions
To eat only during a self-selected window of 12 hours, with no advice on nutrition quality, quantity or caloric intake
Regular dietary advices by a trained dietitian or research nurse according to current nutrition guidelines
Data collection on eating patterns via the smartphone app
Eligibility Criteria
You may qualify if:
- Age ≥ 12 years
- Body mass index ≥ 20 kg/m2 and stable weight (previous 3 months) in adults; BMI ≥ 25th percentile in teenagers
- Smartphone compatible with the app (iOS or Android systems)
- Any component of the metabolic syndrome following the International Diabetes Federation consensus definition
- Eating duration \>14h during the observation phase
- Age 18-40 years, men and pre-menopausal women
- BMI 30-40 kg/m2
- In the fasting state (at least 8 hours)
You may not qualify if:
- Pregnant and breastfeeding women, plans for maternity during the study
- Major illness/fever over the previous month, active cancer
- Eating disorder, on a diet / weight management, prior bariatric surgery
- Major mental illness, unable to give informed consent
- Current shift work or travel abroad planned in the next month
- Prior cardiovascular event
- Major liver, gastrointestinal, renal or endocrine disorder, diabetes mellitus with hypoglycemic drug(s)
- Major sleep disorder, centrally acting medication
- Lipid lowering drug, hypoglycemic drug, medication affecting the gut
- Impaired glucose tolerance (pre-diabetes) or diabetes mellitus
- Positive pregnancy test
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Inselspital, Klinik für Allgemeine Innere Medizin
Bern, Canton of Bern, 3010, Switzerland
University Hospital of Lausanne (CHUV)
Lausanne, 1011, Switzerland
Related Publications (4)
Buso G, Favre L, Vionnet N, Gonzalez-Rodriguez E, Hans D, Puder JJ, Dubath C, Eap CB, Raffoul W, Collet TH, Mazzolai L. Body Composition Assessment by Dual-Energy X-Ray Absorptiometry: A Useful Tool for the Diagnosis of Lipedema. Obes Facts. 2022;15(6):762-773. doi: 10.1159/000527138. Epub 2022 Oct 28.
PMID: 36310013BACKGROUNDPhillips NE, Mareschal J, Schwab N, Manoogian ENC, Borloz S, Ostinelli G, Gauthier-Jaques A, Umwali S, Gonzalez Rodriguez E, Aeberli D, Hans D, Panda S, Rodondi N, Naef F, Collet TH. The Effects of Time-Restricted Eating versus Standard Dietary Advice on Weight, Metabolic Health and the Consumption of Processed Food: A Pragmatic Randomised Controlled Trial in Community-Based Adults. Nutrients. 2021 Mar 23;13(3):1042. doi: 10.3390/nu13031042.
PMID: 33807102BACKGROUNDBorloz S, Bucher Della Torre S, Collet TH, Jotterand Chaparro C. Consumption of Ultraprocessed Foods in a Sample of Adolescents With Obesity and Its Association With the Food Educational Style of Their Parent: Observational Study. JMIR Pediatr Parent. 2021 Nov 15;4(4):e28608. doi: 10.2196/28608.
PMID: 34779776BACKGROUNDPapageorgiou M, Biver E, Mareschal J, Phillips NE, Hemmer A, Biolley E, Schwab N, Manoogian ENC, Gonzalez Rodriguez E, Aeberli D, Hans D, Pot C, Panda S, Rodondi N, Ferrari SL, Collet TH. The effects of time-restricted eating and weight loss on bone metabolism and health: a 6-month randomized controlled trial. Obesity (Silver Spring). 2023 Feb;31 Suppl 1(Suppl 1):85-95. doi: 10.1002/oby.23577. Epub 2022 Oct 14.
PMID: 36239695BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tinh-Hai Collet, MD
University of Lausanne Hospitals
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 2, 2017
First Posted
August 7, 2017
Study Start
September 29, 2017
Primary Completion
March 31, 2021
Study Completion
March 31, 2022
Last Updated
December 6, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Starting 6 months after publication
- Access Criteria
- Upon appropriate data request by other scientists
Anonymized dataset of selected variables that underlie results in a publication. Some data may not be amenable to complete anonymization and will not be shared to ensure appropriate confidentiality of participant's data.