Clinical trial NCT04788836: How Altered Gut-Brain-Axis Influences Food Choices: Part 2 (BrainFood)
Official title: How Altered Gut-Brain-Axis Influences Food Choices. (BrainFood) Part 2: Digital Receipts
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Food Preferences
Obesity
Keywords: Bariatric surgery
Food preferences
Food behaviour
Digital receipts
Grocery Shopping
Obesity treatment
GLP-1 receptor agonist
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: ETH Zurich
First posted: 2021-03-09
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A minimum of 60 (up to a maximum of 150) overweight/obese adults planned for or who started surgical or non-surgical obesity treatment within the past 6 months will be recruited for this study. Participants will be recruited by referral from our outpatient endocrine clinic and collaborating Centres of Excellence for Metabolic Surgery.

Brief summary: 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.

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Changes in food purchase behaviour on the basis of the Healthy Trolley Index (HETI)
timeFrame: Pre-treatment until 5 years after start of obesity treatment
measure: Changes in food purchase behaviour on the basis of the Grocery Purchase Quality Index (GPQI)
timeFrame: Pre-treatment until 5 years after start of obesity treatment
measure: Changes in food purchase behaviour on the basis of food groups
timeFrame: Pre-treatment until 5 years after start of obesity treatment
measure: Changes in food purchase behaviour on the basis of nutrition facts
timeFrame: Pre-treatment until 5 years after start of obesity treatment
measure: Changes in food purchase behaviour on the basis of the Nutri-Score
timeFrame: Pre-treatment until 5 years after start of obesity treatment
measure: Food purchase behaviour on the basis of the Healthy Trolley Index (HETI)
timeFrame: Pre-treatment until 5 years after start of obesity treatment
measure: Food purchase behaviour on the basis of the Grocery Purchase Quality Index (GPQI)
timeFrame: Pre-treatment until 5 years after start of obesity treatment
measure: Food purchase behaviour on the basis of food groups
timeFrame: Pre-treatment until 5 years after start of obesity treatment
measure: Food purchase behaviour on the basis of nutrition facts
timeFrame: Pre-treatment until 5 years after start of obesity treatment
measure: Food purchase behaviour on the basis of the Nutri-Score
timeFrame: Pre-treatment until 5 years after start of obesity treatment
Secondary outcomes:
Other outcomes:
measure: Correlation between food purchase patterns (i.e. HETI, GPQI, food groups, nutrition facts, Nutri-Score) and self-perceived quality of life
timeFrame: Pre-treatment until 5 years after start of obesity treatment
measure: Changes in energy intake
timeFrame: Pre-treatment until 5 years after start of obesity treatment
measure: Changes in daily carbohydrate intake
timeFrame: Pre-treatment until 5 years after start of obesity treatment
measure: Changes in daily sugar intake
timeFrame: Pre-treatment until 5 years after start of obesity treatment
measure: Changes in daily fibre intake
timeFrame: Pre-treatment until 5 years after start of obesity treatment
measure: Changes in daily protein intake
timeFrame: Pre-treatment until 5 years after start of obesity treatment
measure: Changes in daily fat intake
timeFrame: Pre-treatment until 5 years after start of obesity treatment
measure: Changes in daily saturated fat intake
timeFrame: Pre-treatment until 5 years after start of obesity treatment
measure: Changes in daily sodium intake
timeFrame: Pre-treatment until 5 years after start of obesity treatment
measure: Changes in daily vegetable intake
timeFrame: Pre-treatment until 5 years after start of obesity treatment
measure: Changes in daily wholegrain intake
timeFrame: Pre-treatment until 5 years after start of obesity treatment
measure: Changes in daily fruit intake
timeFrame: Pre-treatment until 5 years after start of obesity treatment
measure: Changes in daily dessert intake
timeFrame: Pre-treatment until 5 years after start of obesity treatment
measure: Changes in daily meat intake
timeFrame: Pre-treatment until 5 years after start of obesity treatment
Locations:
city: Bern
country: Switzerland
facility: Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital
Study officials:
affiliation: University Hospital Bern & University of Bern
name: Lia Bally, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: