NCT03252158

Brief Summary

Background: While there is some evidence that increasing the range of healthier foods and drinks and/or decreasing the range of less healthy options may increase healthier choices, more work is needed to establish the reproducibility of any effect. The current study aims to investigate the impact of altering the availability of healthier and less healthy foods and cold beverages in hospital vending machines. Methods: An adapted multiple treatment reversal design will be used, in which all standard vending machines serving snack foods and/or cold beverages in one hospital in England change the number of slots containing (i) less healthy items and (ii) healthier items over eight 4-week periods. Changes will take place in a two-step process whereby decreases are implemented in a separate study period prior to increases in the contrasting food group. Following a 4-week baseline period, all vending machines will be standardised to have 75% healthier drinks and/or 25% healthier snacks (study period 1). Vending machines (n=9) will be randomly allocated to the order in which they: (1) decrease less healthy foods and increase healthier foods or (2) decrease healthier foods and increase less healthy foods (study periods 2\&3 and 5\&6). After each decrease-increase pair, machines will return to the standardised 75% healthier drinks and 25% healthier snacks (study periods 4 and 7). Sales data will be obtained via records of machine restocking. Planned Analysis: The impact of the availability intervention will be assessed in separate linear mixed models for cold drinks and snacks, examining the impact on total energy (kcal) purchased, per restocking interval, with random effects for vending machine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 17, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

August 17, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2018

Completed
Last Updated

May 3, 2018

Status Verified

May 1, 2018

Enrollment Period

7 months

First QC Date

August 9, 2017

Last Update Submit

May 2, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Energy purchased

    Energy purchased (kcal) per restocking interval from intervention (standard-fare) vending machines

    Restocking interval (between 2-4 days; restocking occurs on set weekdays for each machine, to match usual restocking)

Secondary Outcomes (3)

  • Number of items sold

    Restocking interval (between 2-4 days; restocking occurs on set weekdays for each machine, to match usual restocking)

  • Energy purchased (healthier alternative machines)

    Restocking interval (between 2-4 days; restocking occurs on set weekdays for each machine, to match usual restocking)

  • Number of items sold (healthier alternative machines)

    Restocking interval (between 2-4 days; restocking occurs on set weekdays for each machine, to match usual restocking)

Study Arms (2)

Decrease less healthy item availability

EXPERIMENTAL

Intervention: Availability of healthier vs. less healthy foods Remove less healthy items in 20% of slots, then fill the empty slots with healthier items.

Behavioral: Availability of healthier vs. less healthy foods

Decrease healthier item availability

EXPERIMENTAL

Intervention: Availability of healthier vs. less healthy foods Remove healthier items in 20% of slots, then fill the empty slots with less healthy items.

Behavioral: Availability of healthier vs. less healthy foods

Interventions

Altering the number of slots containing (a) healthier and (b) less healthy foods or beverages in hospital vending machines. Changes follow a 2-step process whereby decreases are implemented in a separate study period prior to increases in the contrasting group. Following a 4-week baseline period, all vending machines will be standardised to have 75% healthier drinks and/or 25% healthier snacks (study period 1). Vending machines will be randomly allocated to the order in which they: (1) decrease less healthy foods and increase healthier foods or (2) decrease healthier foods and increase less healthy foods (study periods 2\&3 and 5\&6). After each decrease-increase pair, machines will return to the standardised 75% healthier drinks / 25% healthier snacks (study periods 4 and 7).

Decrease healthier item availabilityDecrease less healthy item availability

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All vending machines at one UK hospital selling standard-fare (i.e. not healthier alternatives) cold beverages and snack foods

You may not qualify if:

  • Healthier alternative vending machines; vending machines selling hot drinks or meals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cambridge

Cambridge, Cambridgeshire, CB2 0SR, United Kingdom

Location

Study Officials

  • Rachel Pechey, PhD

    University of Cambridge

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: An adapted multiple treatment reversal design will be used, in which the number of slots containing (i) less healthy items and (ii) healthier items are altered over eight 4-week periods. Vending machines will be randomly allocated to one of two groups: (1) decreasing less healthy foods first or (2) decreasing healthier foods first.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Associate

Study Record Dates

First Submitted

August 9, 2017

First Posted

August 17, 2017

Study Start

August 17, 2017

Primary Completion

March 28, 2018

Study Completion

March 28, 2018

Last Updated

May 3, 2018

Record last verified: 2018-05

Locations