- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04657627
FOODS: Food shOppers' sOcial meDia Study (FOODS)
October 7, 2021 updated by: Amanda Daley, Loughborough University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
103
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Leicestershire
-
Loughborough, Leicestershire, United Kingdom, LE11 3TU
- Loughborough University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ≥ 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PACE plus calorie information intervention group
PACE plus calorie information intervention group will receive PACE plus calorie information of discretionary foods via social media posts.
|
The intervention group will be exposed to PACE plus calorie labelling information via Instagram and Twitter social media posts every day for 13 weeks.
|
|
Active Comparator: Calorie-only information comparator group
Calorie-only information comparator group will receive calorie-only information of discretionary foods via social media posts.
|
The comparator group will be exposed to calorie-only labelling information via Instagram and Twitter social media posts every day for 13 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in eating behaviour of discretionary foods at 13 weeks
Time Frame: Pre-baseline (one time point prior to randomisation) and post-intervention (one time point after week 13)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cognitive restraint of eating
Time Frame: Pre-baseline (one time point prior to randomisation) and post-intervention (one time point after week 13)
|
A modified version (R18) of the Three-Factor Eating Questionnaire (TFEQ) will be used to measure cognitive restraint.
|
Pre-baseline (one time point prior to randomisation) and post-intervention (one time point after week 13)
|
|
Physical activity
Time Frame: Pre-baseline (one time point prior to randomisation) and post-intervention (one time point after week 13)
|
Self-reported physical activity behaviour will be assessed using the 7-day International Physical Activity Questionnaire (IPAQ)
|
Pre-baseline (one time point prior to randomisation) and post-intervention (one time point after week 13)
|
|
Body weight
Time Frame: Pre-baseline (one time point prior to randomisation), mid-intervention (week 7) and post-intervention (one time point after week 13)
|
Weight will be self-reported via participants own weighing scales.
Participants will electronically send via email photograph evidence of readings of their fasted morning weight from weighing scales, following standardised instructions.
|
Pre-baseline (one time point prior to randomisation), mid-intervention (week 7) and post-intervention (one time point after week 13)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Amanda Daley, Loughborough University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 6, 2021
Primary Completion (Actual)
September 30, 2021
Study Completion (Actual)
October 4, 2021
Study Registration Dates
First Submitted
November 24, 2020
First Submitted That Met QC Criteria
December 1, 2020
First Posted (Actual)
December 8, 2020
Study Record Updates
Last Update Posted (Actual)
October 8, 2021
Last Update Submitted That Met QC Criteria
October 7, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1544
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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