Sugar-Sweetened Beverage Portion Limit Study

February 5, 2024 updated by: Pamela Rothpletz-Puglia, EdD, RD, Rutgers, The State University of New Jersey

Evaluating a Portion Cap Policy on Sugar-Sweetened Beverages

This present study is an evaluation of de-identified data collected previously during a randomized controlled study (RCT). The objective of the original RCT titled "Sugar-Sweetened Beverage (SSB) Portion Limit Dining Lab RCT" was to examine the impact of limiting the portion size of SSB to 16 oz in a laboratory dining setting. The RCT was designed to assess the impact of limiting the size of SSB offered on a restaurant menu and the availability of free fills on beverage and food purchases, consumption and caloric intake at the test meal and subsequent meals (over a 24-hour period).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Briefly, the data for this evaluation were collected from adults recruited from the Boston / Cambridge area to participate in an RCT conducted at an eating behavior lab at the Landmark Center (Lab). Participants were masked to the purpose of the study and were randomized to one of four conditions. To conceal the purpose of the study, participants were asked to participate in a pseudo-focus group pretending to conduct consumer research on restaurant preferences. Participants were asked not to eat after 3 pm prior to the 5:30 pm focus group. Participants were seated at individual dining tables and were asked to order and purchase dinner from a restaurant menu and consumed the meal while in the restaurant Lab. After the focus group, participants completed electronic questionnaires (e.g., demographic information, eating behaviors, and perceptions of the meal). Participants returned to the Lab the following day to complete a brief dietary recall interview. After they completed the study procedures, they were debriefed about the purpose of the study and provided the opportunity to withdraw from the study.

The current evaluation will be conducted under an IRB-approved, apriori, statistical analysis plan using the data collected during the Sugar-Sweetened Beverage (SSB) Portion limit Dining Lab RCT.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
359

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adults 18 years and older
  • Ability to speak and read English
  • Willing to participate and follow protocol specified activities

Exclusion Criteria:

-Severe food allergies

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Current SSB restaurant portions purchase refill
Offered a menu with current SSB restaurant portion sizes with the option to purchase refills
Behavioral: Sweetened beverage portion size limit
Experimental: Current SSB restaurant portions free refill
Offered a menu with current SSB restaurant portion sizes plus free beverage refills
Behavioral: Sweetened beverage portion size limit
Experimental: </= 16 oz. SSB portions with the option to purchase refills
Offered a menu with </= 16 oz. SSB portion sizes with the option to purchase refills
Behavioral: Sweetened beverage portion size limit
Experimental: </= 16 oz. SSB portions plus free refills
Offered a menu with </= 16 oz. SSB portion sizes plus free refills
Behavioral: Sweetened beverage portion size limit

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total calories food and beverages ordered from the study restaurant menu at the test dinner meal
Time Frame: Immediately after Day 1 test dinner meal

Total calories ordered will be computed by summing the calories of each menu item selected for the test dinner meal.

The calorie content for all food and drinks will be based on the nutritional information, posted on the restaurant's website for each menu item.
Immediately after Day 1 test dinner meal
Total calories from food and drink consumed during the test the dinner meal
Time Frame: 24-hours post-Day 1 test dinner meal
Calories consumed will be measured by weighing all food items before and after the test dinner meal using a digital scale accurate up to +0.1 grams. The weight of each plate/cup collected after the meal will be subtracted from the weight of each plate/cup prior to being served. The weight of the food in conjunction with the caloric density of each item will be combined to calculate the total caloric intake for each participant at the test dinner meal.
24-hours post-Day 1 test dinner meal

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total beverage calories ordered at the dinner meal
Time Frame: Immediately after Day 1 test dinner meal
The beverages calorie content of beverage items was based on the nutritional information available online.
Immediately after Day 1 test dinner meal
Total beverage calories consumed at the dinner meal
Time Frame: Immediately after Day 1 test dinner meal
Beverages were weighed before and after the meal to allow for the calculation of total beverage calories consumed. The calorie content of the beverage items was based on the nutritional information available online.
Immediately after Day 1 test dinner meal
Total food calories ordered at the dinner meal
Time Frame: Immediately after Day 1 test dinner meal
The food calorie content was based on the nutritional information available online.
Immediately after Day 1 test dinner meal
Total food calories consumed at the dinner meal
Time Frame: Immediately after Day 1 test dinner meal
Food items were weighed before and after the meal to allow for the calculation of total calories consumed. The calorie content of food items was based on the nutritional information available online.
Immediately after Day 1 test dinner meal
Total calories consumed after the dinner meal
Time Frame: 24-hours post-Day 1 test dinner meal
Total calories participants consumed after the dinner meal were measured with the National Cancer Institute's web-based Automated Self Administered 24-hour Dietary Recall program
24-hours post-Day 1 test dinner meal
Combination of calories consumed at dinner & post-dinner
Time Frame: From immediately after Day 1 test dinner meal until 24-hours post Day 1 dinner meal
This will be calculated by adding the value for total calories consumed at the dinner meal to the value for total calories consumed post-dinner.
From immediately after Day 1 test dinner meal until 24-hours post Day 1 dinner meal

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall satisfaction with the price of the food item/s ordered: 7-point Likert item
Time Frame: Immediately after Day 1 test dinner meal
7-point Likert item (1= not at all satisfied; 7= extremely satisfied]
Immediately after Day 1 test dinner meal
Overall satisfaction with the portion of the food item/s ordered: 7-point Likert item
Time Frame: Immediately after Day 1 test dinner meal
7-point Likert item (1= not at all satisfied; 7= extremely satisfied]
Immediately after Day 1 test dinner meal
Satisfaction with drink size
Time Frame: Immediately after Day 1 test dinner meal
Too small, Just right, Too big
Immediately after Day 1 test dinner meal
Pre-meal hunger
Time Frame: Immediately after Day 1 test dinner meal
Before eating this meal, how hungry were you? [7-point Likert item (1= not at all hungry, 7= extremely hungry)]
Immediately after Day 1 test dinner meal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rutgers, The State University of New Jersey

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Christina A Roberto, PhD, University of Pennsylvania

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 14, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 27, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 27, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 12, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro2019001933

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be made publically available, upon request

IPD Sharing Time Frame

Data and supporting information will become available starting 6 months after the final analysis is completed and the summary data are published.

IPD Sharing Access Criteria

Contact the Study Investigators for information on how to access the data and supporting information

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

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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