Sugar-Sweetened Beverage Portion Limit Study

NCT04197063 | Completed

• 1 other identifier: Pro2019001933
• Study Type: interventional
• Target: 359
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Health Policy

Keywords

sweetened beverage; portion size; policy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Total beverage calories ordered at the dinner meal

  Immediately after Day 1 test dinner meal

• Total beverage calories consumed at the dinner meal

  Immediately after Day 1 test dinner meal

• Total food calories ordered at the dinner meal

  Immediately after Day 1 test dinner meal

• Total food calories consumed at the dinner meal

  Immediately after Day 1 test dinner meal

• Total calories consumed after the dinner meal

  24-hours post-Day 1 test dinner meal

Other Outcomes (4)

• Overall satisfaction with the price of the food item/s ordered: 7-point Likert item

  Immediately after Day 1 test dinner meal

• Overall satisfaction with the portion of the food item/s ordered: 7-point Likert item

  Immediately after Day 1 test dinner meal

• Satisfaction with drink size

  Immediately after Day 1 test dinner meal

Study Arms (4)

Current SSB restaurant portions purchase refill

EXPERIMENTAL

Offered a menu with current SSB restaurant portion sizes with the option to purchase refills

Behavioral: Sweetened beverage portion size limit

Current SSB restaurant portions free refill

EXPERIMENTAL

Offered a menu with current SSB restaurant portion sizes plus free beverage refills

Behavioral: Sweetened beverage portion size limit

</= 16 oz. SSB portions with the option to purchase refills

EXPERIMENTAL

Offered a menu with \</= 16 oz. SSB portion sizes with the option to purchase refills

Behavioral: Sweetened beverage portion size limit

</= 16 oz. SSB portions plus free refills

EXPERIMENTAL

Offered a menu with \</= 16 oz. SSB portion sizes plus free refills

Behavioral: Sweetened beverage portion size limit

Interventions

Sweetened beverage portion size limit BEHAVIORAL

</= 16 oz. SSB portions plus free refills; </= 16 oz. SSB portions with the option to purchase refills; Current SSB restaurant portions free refill; Current SSB restaurant portions purchase refill

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Severe food allergies

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Officials

• Christina A Roberto, PhD

  University of Pennsylvania

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The data was collected during a sham focus group where the purpose of the study was concealed from the participants. The purpose of the study was unmasked to participants when they returned on the following day and completed the study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This study randomized participants to one of four conditions: 1) Current SSB restaurant portion sizes with the option to purchase beverage refills; 2) Current SSB restaurant portions plus free refills; 3) \</= 16 oz. SSB portions with the option to purchase beverage refills; or 4) \</= 16 oz. SSB portions plus free refills.

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: December 12, 2019
• Study Start: January 14, 2015
• Primary Completion: August 27, 2015
• Study Completion: August 27, 2015
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data and supporting information will become available starting 6 months after the final analysis is completed and the summary data are published.
• Access Criteria: Contact the Study Investigators for information on how to access the data and supporting information