How Altered Gut-Brain-Axis Influences Food Choices: Part 2 (BrainFood)

NCT04788836 | Active Not Recruiting

• 1 other identifier: BrainFood Part 2
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Preferences; Obesity

Keywords

Bariatric surgery; Food preferences; Food behaviour; Digital receipts; Grocery Shopping; Obesity treatment; GLP-1 receptor agonist

Outcome Measures

Primary Outcomes (10)

• Changes in food purchase behaviour on the basis of the Healthy Trolley Index (HETI)

  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.

  Pre-treatment until 5 years after start of obesity treatment

• Changes in food purchase behaviour on the basis of the Grocery Purchase Quality Index (GPQI)

  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.

  Pre-treatment until 5 years after start of obesity treatment

• Changes in food purchase behaviour on the basis of food groups

  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.

  Pre-treatment until 5 years after start of obesity treatment

• Changes in food purchase behaviour on the basis of nutrition facts

  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.

  Pre-treatment until 5 years after start of obesity treatment

• Changes in food purchase behaviour on the basis of the Nutri-Score

  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)).

  Pre-treatment until 5 years after start of obesity treatment

• Food purchase behaviour on the basis of the Healthy Trolley Index (HETI)

  HETI will be compared between obesity treatment group and control group

  Pre-treatment until 5 years after start of obesity treatment

• Food purchase behaviour on the basis of the Grocery Purchase Quality Index (GPQI)

  GPQI will be compared between obesity treatment group and control group

  Pre-treatment until 5 years after start of obesity treatment

• Food purchase behaviour on the basis of food groups

  Food groups will be compared between obesity treatment group and control group

  Pre-treatment until 5 years after start of obesity treatment

• Food purchase behaviour on the basis of nutrition facts

  Nutrition facts will be compared between obesity treatment group and control group

  Pre-treatment until 5 years after start of obesity treatment

• Food purchase behaviour on the basis of the Nutri-Score

  Nutri-Score will be compared between obesity treatment group and control group

  Pre-treatment until 5 years after start of obesity treatment

Other Outcomes (14)

• Correlation between food purchase patterns (i.e. HETI, GPQI, food groups, nutrition facts, Nutri-Score) and self-perceived quality of life

  Pre-treatment until 5 years after start of obesity treatment

• Changes in energy intake

  Pre-treatment until 5 years after start of obesity treatment

• Changes in daily carbohydrate intake

  Pre-treatment until 5 years after start of obesity treatment

Study Arms (2)

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

Other: Questionnaire (Survey and Food Frequency Questionnaire (FFQ)); Other: Collection of digital receipts from grocery shopping

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.

Interventions

Questionnaire (Survey and Food Frequency Questionnaire (FFQ)) OTHER

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.

Obesity treatment Group

Collection of digital receipts from grocery shopping OTHER

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

Obesity treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• Incapacity to give informed consent
• Primary shopping in other food retailers (e.g. Aldi, Lidl, outside of Switzerland, etc.)

Sponsors & Collaborators

• Lia Bally: lead
• ETH Zurich: collaborator

Study Sites (1)

Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Food Preferences; Obesity

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Lia Bally, MD, PhD

  University Hospital Bern & University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: March 9, 2021
• Study Start: November 1, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 25, 2025

Record last verified: 2025-06

Locations

CH (1)