Sugar-Sweetened Beverage Portion Limit Study

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: Completed
• Conditions: Health Policy
• Intervention / Treatment: Behavioral: Sweetened beverage portion size limit

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: Interventional
• Enrollment (Actual): 359
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Total calories food and beverages ordered from the study restaurant menu at the 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	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

Outcome Measure	Measure Description	Time Frame
Total beverage calories ordered at the 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	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	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	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	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	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

Outcome Measure	Measure Description	Time Frame
Overall satisfaction with the price of the food item/s ordered: 7-point Likert item	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	7-point Likert item (1= not at all satisfied; 7= extremely satisfied]	Immediately after Day 1 test dinner meal
Satisfaction with drink size	Too small, Just right, Too big	Immediately after Day 1 test dinner meal
Pre-meal hunger	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

• Sponsor: Rutgers, The State University of New Jersey
• Investigators: Study Director: Christina A Roberto, PhD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2015
• Primary Completion (Actual): August 27, 2015
• Study Completion (Actual): August 27, 2015

Study Registration Dates

• First Submitted: October 10, 2019
• First Submitted That Met QC Criteria: December 10, 2019
• First Posted (Actual): December 12, 2019

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: portion size; sweetened beverage; policy
• Other Study ID 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