- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04788836
How Altered Gut-Brain-Axis Influences Food Choices: Part 2 (BrainFood) (BrainFood)
How Altered Gut-Brain-Axis Influences Food Choices. (BrainFood) Part 2: Digital Receipts
Obesity is currently one of the most substantial health burdens. Due to the production of marked and sustained weight loss, bariatric surgery is an increasingly used therapeutic modality to combat obesity and its comorbidities. Surgical rearrangement of the gastrointestinal tract remarkably alters metabolism and hormones acting on neurological and hypothalamic signalling, involved in food decision-making and eating behaviour. In this context, many patients who underwent bariatric surgery self-report changes in appetite, satiety and food preferences. Furthermore, new gut hormone-based (e.g. GLP-1 receptor agonist or GLP-1-RA) pharmacotherapies which mimic the effect of bariatric surgery show impressive efficacy on weight reduction by modulation of food behaviour. However, the mechanisms of such functional changes, and how they relate to food decision-making and food purchase behaviour remain unknown.
In Part 2 of the BrainFood-project, the investigators propose a novel approach using digital receipts from loyalty card to unravel the effect of obesity treatments (surgical and non-surgical) on eating and food purchase behaviour in daily life.
Study Overview
Status
Conditions
Detailed Description
The overall aim of this project is to elucidate the changes in food behaviour among obese adults undergoing obesity treatments.
The main objective is to observe the effect of obesity treatments on food purchase behaviour using digital receipts from grocery shopping. The investigators hypothesize that bariatric surgery leads to changes in food purchase behaviour in obese adults.
The further objective is to compare food purchase behaviour between obese adults against values of an existing reference population, and to assess whether these differences tend to be reduced after the start of the treatment among obese participants.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Lia Bally, MD, PhD
- Phone Number: +41 316323677
- Email: lia.bally@insel.ch
Study Locations
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Bern, Switzerland, 3010
- Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Female and male subjects aged 18 years or older
- Proficient in German (including written)
- BMI≥30kg/m2 or BMI≥28kg/m2 with adiposity-related comorbidities (prediabetes, type 2 diabetes mellitus, hypertension, dyslipidemia)
- Referred for obesity treatment or who started obesity treatment within 6 months (surgical or non-surgical)
- Primary grocery shopping at the Swiss biggest grocery retailers (Coop, Migros), and regularly using a loyalty card (Cumulus and/or Supercard)
Exclusion Criteria:
- Incapacity to give informed consent
- Primary shopping in other food retailers (e.g. Aldi, Lidl, outside of Switzerland, etc.)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Obesity treatment Group
60 (minimum) to 150 (maximum) overweight/obese adults referred for or who started obesity (surgical or non-surgical) treatment within 6 months
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Each participant will be asked to fill a web-based questionnaire that captures sociodemographic, lifestyle, physical and mental health information (Survey) and dietary intake patterns (FFQ).
This will be done pre-treatment (only for those included pre-treatment), 6 months after the start of obesity treatment, 1 year after the start of the treatment and then yearly until 5 year after the start of the treatment.
Participants will create their BitsaboutMe-account (GDPR-compliant data sharing platform from Bern, Switzerland) with the help of study team members. Data from digital receipts will be obtained from Migros Cumulus and Coop Supercard via their BitsaboutMe-account. The data collection allow retrospective digital receipts collection for up to 2 years and automatically continuous collection during study duration. GDPR: General Data Protection Regulation |
Control Group
Comparison of food purchase behaviour with control subjects will be performed using an already existing cohort from a previous study.
This does not required recruiting control subjects.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in food purchase behaviour on the basis of the Healthy Trolley Index (HETI)
Time Frame: Pre-treatment until 5 years after start of obesity treatment
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Changes in food purchase behaviour pre-treatment will be compared to post-treatment on the basis of the HETI, an objective and validated, nutrient-based, healthy shopping scoring system.
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Pre-treatment until 5 years after start of obesity treatment
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Changes in food purchase behaviour on the basis of the Grocery Purchase Quality Index (GPQI)
Time Frame: Pre-treatment until 5 years after start of obesity treatment
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Changes in food purchase behaviour pre-treatment will be compared to post-treatment on the basis of the GPQI, an objective and validated, nutrient-based, healthy shopping scoring system.
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Pre-treatment until 5 years after start of obesity treatment
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Changes in food purchase behaviour on the basis of food groups
Time Frame: Pre-treatment until 5 years after start of obesity treatment
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Changes in food purchase behaviour pre-treatment will be compared to post-treatment on the basis of food groups like vegetables, wholegrain, fruits, sweets and meats.
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Pre-treatment until 5 years after start of obesity treatment
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Changes in food purchase behaviour on the basis of nutrition facts
Time Frame: Pre-treatment until 5 years after start of obesity treatment
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Changes in food purchase behaviour pre-treatment will be compared to post-treatment on the basis of nutrition facts like energy (kcal), carbohydrates, sugars, added sugars, protein, fat, saturated fat, dietary fibre and salt.
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Pre-treatment until 5 years after start of obesity treatment
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Changes in food purchase behaviour on the basis of the Nutri-Score
Time Frame: Pre-treatment until 5 years after start of obesity treatment
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Changes in food purchase behaviour pre-treatment will be compared to post-treatment on the basis of the Nutri-Score, representing the nutritional quality of products.
The Nutri-Score is based on a discrete continuous scale from -15 (most healthy) to 40 (least healthy).
The score is then transcribed into five colour categories (A-E, ranging from bright green (most healthy) to red (least healthy)).
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Pre-treatment until 5 years after start of obesity treatment
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Food purchase behaviour on the basis of the Healthy Trolley Index (HETI)
Time Frame: Pre-treatment until 5 years after start of obesity treatment
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HETI will be compared between obesity treatment group and control group
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Pre-treatment until 5 years after start of obesity treatment
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Food purchase behaviour on the basis of the Grocery Purchase Quality Index (GPQI)
Time Frame: Pre-treatment until 5 years after start of obesity treatment
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GPQI will be compared between obesity treatment group and control group
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Pre-treatment until 5 years after start of obesity treatment
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Food purchase behaviour on the basis of food groups
Time Frame: Pre-treatment until 5 years after start of obesity treatment
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Food groups will be compared between obesity treatment group and control group
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Pre-treatment until 5 years after start of obesity treatment
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Food purchase behaviour on the basis of nutrition facts
Time Frame: Pre-treatment until 5 years after start of obesity treatment
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Nutrition facts will be compared between obesity treatment group and control group
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Pre-treatment until 5 years after start of obesity treatment
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Food purchase behaviour on the basis of the Nutri-Score
Time Frame: Pre-treatment until 5 years after start of obesity treatment
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Nutri-Score will be compared between obesity treatment group and control group
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Pre-treatment until 5 years after start of obesity treatment
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between food purchase patterns (i.e. HETI, GPQI, food groups, nutrition facts, Nutri-Score) and self-perceived quality of life
Time Frame: Pre-treatment until 5 years after start of obesity treatment
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Quality of life will be assessed using on a scale from 1 (very bad) to 5 (very good)
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Pre-treatment until 5 years after start of obesity treatment
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Changes in energy intake
Time Frame: Pre-treatment until 5 years after start of obesity treatment
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Energy intake in kilocalories (kcal)/day based on Food Frequency Questionnaire
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Pre-treatment until 5 years after start of obesity treatment
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Changes in daily carbohydrate intake
Time Frame: Pre-treatment until 5 years after start of obesity treatment
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Dietary intake in gram/day based on Food Frequency Questionnaire
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Pre-treatment until 5 years after start of obesity treatment
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Changes in daily sugar intake
Time Frame: Pre-treatment until 5 years after start of obesity treatment
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Dietary intake in gram/day based on Food Frequency Questionnaire
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Pre-treatment until 5 years after start of obesity treatment
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Changes in daily fibre intake
Time Frame: Pre-treatment until 5 years after start of obesity treatment
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Dietary intake in gram/day based on Food Frequency Questionnaire
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Pre-treatment until 5 years after start of obesity treatment
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Changes in daily protein intake
Time Frame: Pre-treatment until 5 years after start of obesity treatment
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Dietary intake in gram/day based on Food Frequency Questionnaire
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Pre-treatment until 5 years after start of obesity treatment
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Changes in daily fat intake
Time Frame: Pre-treatment until 5 years after start of obesity treatment
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Dietary intake in gram/day based on Food Frequency Questionnaire
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Pre-treatment until 5 years after start of obesity treatment
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Changes in daily saturated fat intake
Time Frame: Pre-treatment until 5 years after start of obesity treatment
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Dietary intake in gram/day based on Food Frequency Questionnaire
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Pre-treatment until 5 years after start of obesity treatment
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Changes in daily sodium intake
Time Frame: Pre-treatment until 5 years after start of obesity treatment
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Dietary intake in milligram/day based on Food Frequency Questionnaire
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Pre-treatment until 5 years after start of obesity treatment
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Changes in daily vegetable intake
Time Frame: Pre-treatment until 5 years after start of obesity treatment
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Dietary intake in gram/day based on Food Frequency Questionnaire
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Pre-treatment until 5 years after start of obesity treatment
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Changes in daily wholegrain intake
Time Frame: Pre-treatment until 5 years after start of obesity treatment
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Dietary intake in gram/day based on Food Frequency Questionnaire
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Pre-treatment until 5 years after start of obesity treatment
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Changes in daily fruit intake
Time Frame: Pre-treatment until 5 years after start of obesity treatment
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Dietary intake in gram/day based on Food Frequency Questionnaire
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Pre-treatment until 5 years after start of obesity treatment
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Changes in daily dessert intake
Time Frame: Pre-treatment until 5 years after start of obesity treatment
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Dietary intake in gram/day based on Food Frequency Questionnaire
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Pre-treatment until 5 years after start of obesity treatment
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Changes in daily meat intake
Time Frame: Pre-treatment until 5 years after start of obesity treatment
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Dietary intake in gram/day based on Food Frequency Questionnaire
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Pre-treatment until 5 years after start of obesity treatment
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lia Bally, MD, PhD, University Hospital Bern & University of Bern
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BrainFood Part 2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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