Sugar-Sweetened Beverage Portion Limit Study

NCT ID: NCT04197063

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 359 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-14
• Study Completion Date: 2015-08-27

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).

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.

Conditions

Health Policy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Current SSB restaurant portions purchase refill

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

Group Type: EXPERIMENTAL

Sweetened beverage portion size limit

Intervention Type: BEHAVIORAL

Current SSB restaurant portions free refill

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

Group Type: EXPERIMENTAL

Sweetened beverage portion size limit

Intervention Type: BEHAVIORAL

</= 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

Group Type: EXPERIMENTAL

Sweetened beverage portion size limit

Intervention Type: BEHAVIORAL

</= 16 oz. SSB portions plus free refills

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

Group Type: EXPERIMENTAL

Sweetened beverage portion size limit

Intervention Type: BEHAVIORAL

Interventions

Sweetened beverage portion size limit

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Pamela Rothpletz-Puglia, EdD, RD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christina A Roberto, PhD

Role: STUDY_DIRECTOR

University of Pennsylvania

Other Identifiers

Pro2019001933

Identifier Type: -

Identifier Source: org_study_id