跳至主要内容
临床试验/NCT04788836
NCT04788836已完成不适用

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

Lia Bally2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2021年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
61
试验地点
2
主要终点
Changes in food purchase behaviour on the basis of food groups

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

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

研究组 & 干预措施

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

干预措施: Questionnaire (Survey and Food Frequency Questionnaire (FFQ)) (Other)

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

干预措施: Collection of digital receipts from grocery shopping (Other)

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.

结局指标

主要结局

Changes in food purchase behaviour on the basis of food groups

时间窗: Pre-treatment until 5 years after start of obesity treatment

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.

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

时间窗: Pre-treatment until 5 years after start of obesity treatment

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.

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

时间窗: Pre-treatment until 5 years after start of obesity treatment

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.

Food purchase behaviour on the basis of food groups

时间窗: Pre-treatment until 5 years after start of obesity treatment

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

Food purchase behaviour on the basis of nutrition facts

时间窗: Pre-treatment until 5 years after start of obesity treatment

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

Changes in food purchase behaviour on the basis of nutrition facts

时间窗: Pre-treatment until 5 years after start of obesity treatment

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.

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

时间窗: Pre-treatment until 5 years after start of obesity treatment

HETI will be compared between obesity treatment group and control group

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

时间窗: Pre-treatment until 5 years after start of obesity treatment

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)).

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

时间窗: Pre-treatment until 5 years after start of obesity treatment

GPQI will be compared between obesity treatment group and control group

Food purchase behaviour on the basis of the Nutri-Score

时间窗: Pre-treatment until 5 years after start of obesity treatment

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

次要结局

未报告次要终点

研究者

发起方
Lia Bally
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lia Bally

Professor

Insel Gruppe AG, University Hospital Bern

研究点 (2)

Loading locations...

相似试验