NCT04657627

Brief Summary

This study aims to assess the effects of a new approach to food labelling called physical activity calorie equivalent (PACE) labelling. PACE food labelling provides the public with information about how many minutes (or miles/kilometres) of physical activity (e.g. walking or running) are equivalent to the calories contained in foods.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 8, 2020

Completed
29 days until next milestone

Study Start

First participant enrolled

January 6, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2021

Completed
Last Updated

October 8, 2021

Status Verified

October 1, 2021

Enrollment Period

9 months

First QC Date

November 24, 2020

Last Update Submit

October 7, 2021

Conditions

Keywords

Nutrition labellingPhysical activitySocial media

Outcome Measures

Primary Outcomes (1)

  • Change in eating behaviour of discretionary foods at 13 weeks

    Eating behaviour of discretionary foods will be assessed by a modified version of Online Food Frequency Questionnaire (eNutri FFQ), designed to measure habitual food intake. Participants will record frequencies of discretionary food and drink items eaten during the last month (e.g. "1/week" or "1/day").

    Pre-baseline (one time point prior to randomisation) and post-intervention (one time point after week 13)

Secondary Outcomes (3)

  • Cognitive restraint of eating

    Pre-baseline (one time point prior to randomisation) and post-intervention (one time point after week 13)

  • Physical activity

    Pre-baseline (one time point prior to randomisation) and post-intervention (one time point after week 13)

  • Body weight

    Pre-baseline (one time point prior to randomisation), mid-intervention (week 7) and post-intervention (one time point after week 13)

Study Arms (2)

PACE plus calorie information intervention group

EXPERIMENTAL

PACE plus calorie information intervention group will receive PACE plus calorie information of discretionary foods via social media posts.

Behavioral: PACE plus calorie labelling information

Calorie-only information comparator group

ACTIVE COMPARATOR

Calorie-only information comparator group will receive calorie-only information of discretionary foods via social media posts.

Behavioral: Calorie-only labelling information

Interventions

The intervention group will be exposed to PACE plus calorie labelling information via Instagram and Twitter social media posts every day for 13 weeks.

PACE plus calorie information intervention group

The comparator group will be exposed to calorie-only labelling information via Instagram and Twitter social media posts every day for 13 weeks.

Calorie-only information comparator group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 18 years old.
  • BMI of ≥ 18.5 kg/m2.
  • ≤ 3kg weight loss in previous 6 months.
  • Access and ability to use personal Twitter and/or Instagram account via own smartphone, computer or tablet device.
  • Access to the internet.
  • Access to a set of weighing scales.

You may not qualify if:

  • Unable to read and understand English.
  • Experienced in the last 12 months or currently undergoing any of the following conditions or illnesses: coronary heart disease (CHD), hypertension, heart failure, stroke/transient ischaemic attack, atrial fibrillation, type 2 diabetes, chronic obstructive pulmonary disease (COPD), painful condition, dementia and cancer.
  • Had bariatric surgery.
  • Pregnant, lactating or planning to become pregnant in the next 12 months.
  • Parallel participation in another weight, dietary or physical activity intervention study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loughborough University

Loughborough, Leicestershire, LE11 3TU, United Kingdom

Location

MeSH Terms

Conditions

Motor ActivityBody Weight

Condition Hierarchy (Ancestors)

BehaviorSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Amanda Daley

    Loughborough University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants will be randomised to one of two groups for 13 weeks: (i) PACE plus calorie information intervention group or (ii) calorie-only information comparator group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Amanda Daley

Study Record Dates

First Submitted

November 24, 2020

First Posted

December 8, 2020

Study Start

January 6, 2021

Primary Completion

September 30, 2021

Study Completion

October 4, 2021

Last Updated

October 8, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations