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NCT06072300: PACE-VEND
Effects of Physical Activity Calorie Equivalent Labelling on Hot Drink Vending Transactions
Phase 3 trial testing Physical activity calorie equivalent labelling in Averaged Kilocalories Per Beverage Transaction in 20,000 participants. Status unknown.
31 May 2024
Quick facts
| Lead sponsor | Loughborough University |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 20,000 |
| Start date | 30 October 2023 |
| Primary completion | 31 May 2024 |
| Estimated completion | 31 May 2024 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Physical activity calorie equivalent labelling
Conditions studied
- Averaged Kilocalories Per Beverage Transaction — all drugs for Averaged Kilocalories Per Beverage Transaction →
- Proportion of Total High Calorie Beverages — all drugs for Proportion of Total High Calorie Beverages →
- Total Number of Beverage Transactions — all drugs for Total Number of Beverage Transactions →
Sponsor
Loughborough University
Who can join
18 and older, any sex, with Averaged Kilocalories Per Beverage Transaction or Proportion of Total High Calorie Beverages. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Food nutritional labels are one way to support people to make more informed, healthier food choices. However, there is limited evidence from trials showing that nutrition information on food or drinks is changing the food purchasing or food/beverage consumption behaviours. Many people do not understand the meaning of kilocalories (kcals, calories) or grams of fat displayed on food labels, and often underestimate the number of calories when labelling is not provided. An alternative or complementary approach to current nutrition labelling, is to provide calorie information with a clear interpretation of what the calorie content of the food item/meal or beverage means in terms of energy expenditure. This approach has been called physical activity calorie equivalent (or expenditure) labelling (PACE), which aims to show the public how many minutes (or miles/kilometres) of physical activity (e.g. walking or running) are equivalent to the calories contained in food/beverages. For example, "the calories in this chocolate bar require 95 minutes of walking to burn off". One context in which the public consume a lot of calories is from vending machines. We hypothesise that providing consumers with PACE information on hot beverage vending machines will reduce the average number of calories per transaction dispensed from the vending machines compared with when no PACE information/labelling is presented on vending machines. The study will adopt what is called a stepped wedge randomised controlled trial design involving 42 hot beverage vending machines in 27 buildings (clusters). Clusters will be randomly allocated to one of eight sequences across 24 weeks, which will dictate the time (weeks) at which clusters display the vending machine PACE labelling intervention. Weeks one to four will constitute a baseline period, during which the data will be collected from all vending machines without PACE labelling in place. This will be followed by 20 weeks during which the PACE labelling intervention will be introduced and maintained at each building according to a stepped wedge design (Figure 2). Specifically, every two weeks, three or four clusters will move to the intervention condition. The number of transactions from the vending machines will be collected over the study period and we will compare the number of transactions in the weeks when the PACE labelling is displayed compared to when it was not.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06072300 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Loughborough University
- Last refreshed: 12 December 2023
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