Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Using the Norm Range to Predict the Effect of Food Portion Size Reductions on Compensation Over 5 Days

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03811210
Recruitment Status : Completed
First Posted : January 22, 2019
Last Update Posted : January 24, 2019
Sponsor:
Collaborator:
Medical Research Council
Information provided by (Responsible Party):
Eric Robinson, University of Liverpool

Brief Summary:
Reducing food portion size is a potential strategy to reduce energy intake. However it is unclear at what point consumers compensate for reductions in portion size by increasing energy intake from other items. This could result in no overall benefit of reducing food portion sizes. The investigators tested the hypothesis that reductions to the portion size of components of a main meal will only result in significant compensatory eating when the reduced portion size is no longer visually perceived as 'normal'. In a crossover experiment, participants were served different sized portions during lunch and dinner over 5 days: a 'large-normal', a 'small-normal', and a 'smaller than normal' portion. Intake from all other meal components consumed in the laboratory were measured.

Condition or disease Intervention/treatment Phase
Portion Size Behavioral: portion size Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Using the Norm Range to Predict the Effect of Food Portion Size Reductions on Compensation
Actual Study Start Date : February 6, 2018
Actual Primary Completion Date : December 7, 2018
Actual Study Completion Date : December 10, 2018

Intervention Details:
  • Behavioral: portion size

    Smaller than normal portion size - the intervention is the main meal component size perceived as 'smaller than normal' that participants are provided with during lunch and dinner in the laboratory.

    Small-normal portion size - the intervention is the main meal component size perceived as 'small-normal' that participants are provided with during lunch and dinner in the laboratory.

    Large-normal portion size - the intervention is the main meal component size perceived as 'large-normal' that participants are provided with during lunch and dinner in the laboratory.



Primary Outcome Measures :
  1. Acute compensatory energy intake [ Time Frame: Immediate (within single meal occasion) ]
    Energy intake from main meal components that are not varied by portion size

  2. Total meal energy intake [ Time Frame: Immediate (within single meal occasion) ]
    Energy intake from all main meal components (including those that are and are not varied by portion size)

  3. Total daily energy intake [ Time Frame: Over 5 x full days ]
    Energy intake from all foods consumed, including those provided in the laboratory and those self-reported


Secondary Outcome Measures :
  1. Moderate-vigorous physical activity [ Time Frame: Over 5 x full days ]
    Moderate-vigorous physical activity (recorded using accelerometer device)

  2. Discretionary Leisure-time physical activity [ Time Frame: Over 5 x full days ]
    Discretionary Leisure-time physical activity (recorded with self-report measure International Physical Activity Questionnaire)

  3. Appetite [ Time Frame: Over 5 x full days (measured before and after each meal occasion) ]
    Hunger and fullness sensations before and after laboratory-based meals (self-reported on visual analog scales anchored at 0 'not at all' to 100 'extremely')



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • willing to consume the test foods
  • BMI between 22.5 - 32.5

Exclusion Criteria:

  • food allergies, intolerances or specific dietary requirements (including being vegetarian or vegan)
  • history of eating disorders
  • taking medication which affected appetite
  • participated in a portion size studies in the past 12 months, or in dieting or weight loss trials in the past 4 weeks

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03811210


Locations
Layout table for location information
United Kingdom
Ashleigh Haynes
Liverpool, Merseyside, United Kingdom, L3 6AA
Sponsors and Collaborators
University of Liverpool
Medical Research Council

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Eric Robinson, Reader in Psychological Sciences, University of Liverpool
ClinicalTrials.gov Identifier: NCT03811210    
Other Study ID Numbers: Portion size trial
First Posted: January 22, 2019    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for primary outcome measures, demographic variables, and data reported in resulting publication will be made freely available on Open Science Framework
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Study protocol and statistical analysis plan, along with IPD data will be made publicly available on Open Science Framework when results are published
Access Criteria: Data will be freely accessible.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No