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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04657627
Other study ID # 1544
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 6, 2021
Est. completion date October 4, 2021

Study information

Verified date October 2021
Source Loughborough University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 103
Est. completion date October 4, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United Kingdom Loughborough University Loughborough Leicestershire

Sponsors (3)

Lead Sponsor Collaborator
Loughborough University Alexandra Todd, Dr Oonagh Markey

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Cognitive restraint of eating 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)
Secondary Physical activity 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)
Secondary Body weight 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)
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