Study of Eating Patterns with a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome

Not Applicable

Completed

• Conditions: Obesity; Steatosis of Liver; Metabolic Syndrome; Glucose Intolerance; Dyslipidemias; Eating Behavior
• Interventions: Behavioral: Time restricted feeding; Behavioral: Regular dietary advices; Device: Eating patterns

• Registration Number: NCT03241121
• Lead Sponsor: University of Lausanne Hospitals

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

Detailed Description

The prevalence of the metabolic syndrome (MS) is increasing worldwide, due to the progression of its different components (central obesity, elevated blood pressure, impaired glucose tolerance and dyslipidemia), as well as the often associated liver steatosis. One way to tackle the obesity epidemic is to intervene early at the onset in childhood and teenage years - before cardio-metabolic complications have occurred. However, lifestyle programs targeting this age group had limited success in the current obesogenic environment. In particular, weight loss is a key factor in controlling all MS components, yet it is difficult to maintain over time.

Time restricted feeding (TRF) is an approach that emphasizes energy intake limited to certain windows of time within the 24-hour cycle without restrictions on calories or macronutrients. This has emerged as an appealing approach to reduce body weight while improving lipid profile and glucose metabolism. However, TRF has been mostly studied in animals and long-term prospective data on its efficacy and mechanisms in humans is lacking.

Prior to the intervention, the investigators will assess the eating patterns of participants with an innovative smartphone application ('app') which is less intrusive and more reliable than food diaries/questionnaires to assess eating behavior and patterns.

In this project, the investigators will assess eating patterns among teenagers and adults, and investigate whether a controlled TRF intervention leads to beneficial changes in MS components. Study Part 1 uses an epidemiological approach to establish baseline daily eating behavior, physical activity patterns and sleeping habits over 2 weeks (teenagers) and 4 weeks (adults) using the smartphone app. Those individuals meeting criteria for at least one component of MS and who have eaten for \>14 hours per 24-hour cycle will be recruited for Study Part 2. In Part 2, participants will be assigned to TRF or active control groups, and followed in this pragmatic randomized controlled trial for 6 weeks (teenagers) and 6 months (adults) to assess the change in their weight and MS components, as well as liver fat deposits. Study Part 3 will investigate the underlying mechanisms of improved metabolic profile with TRF.

Study Timeline

• Study First Submitted: 2017-04-02
• Study First Submitted QC: 2017-08-02
• Study First Posted: 2017-08-07
• Study Start: 2017-09-29
• Primary Completion: 2021-03-31
• Study Completion: 2022-03-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 235

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Time restricted feeding	Eating patterns	For those in the intervention phase (Part 2)
Regular dietary advices	Eating patterns	For those in the intervention phase (Part 2)
Time restricted feeding	Time restricted feeding	For those in the intervention phase (Part 2)
Regular dietary advices	Regular dietary advices	For those in the intervention phase (Part 2)

Primary Outcome Measures

Name	Time	Method
Eating duration	From baseline visit to end of observation phase (Part 1: 4 weeks for adults, 2 weeks for teenagers)	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).
Change of metabolic syndrome components	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)	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.

Secondary Outcome Measures

Name	Time	Method
Change in fraction of calories consumed after noon	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)	Estimation of caloric content from food pictures collected by the smartphone app
Adherence to TRF intervention	From randomization visit to close-out visit (Part 2: 6 months for adults, 6 weeks for teenagers)	After allocation to the TRF arm, assessment of the adherence to the intervention, as measured by eating duration from the first to last caloric intake over 24-hour cycle.
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)	Part of the composite primary outcome in the intervention phase (Part 2)
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)	Systolic and diastolic blood pressure
Change in hepatic steatosis / fibrosis score	From randomization visit to close-out visit (Part 2: 6 months for adults, 6 weeks for teenagers)	As measured by the Fibroscan device
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)	Part of the composite primary outcome in the intervention phase (Part 2)
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)	Part of the composite primary outcome in the intervention phase (Part 2)
Change in number of meals per day	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)	Temporal analysis of caloric intake events collected by the smartphone app
Change in meal intervals	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)	Temporal analysis of caloric intake events collected by the smartphone app
Change in fraction of calories consumed after 6pm	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)	Estimation of caloric content from food pictures collected by the smartphone app
Change in eating pattern difference between weekdays and weekends	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)	Indirect assessment of different lifestyle habits during weekdays and weekends

Trial Locations

Locations (2)

Inselspital, Klinik für Allgemeine Innere Medizin; 🇨🇭 Bern, BE, Switzerland

University Hospital of Lausanne (CHUV); 🇨🇭 Lausanne, Switzerland