Clinical trial NCT04197063: Sugar-Sweetened Beverage Portion Limit Study
Official title: Evaluating a Portion Cap Policy on Sugar-Sweetened Beverages
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Policy
Keywords: sweetened beverage
portion size
policy
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2019-12-12
Enrollment: 359
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Total calories food and beverages ordered from the study restaurant menu at the test dinner meal
timeFrame: Immediately after Day 1 test dinner meal
measure: Total calories from food and drink consumed during the test the dinner meal
timeFrame: 24-hours post-Day 1 test dinner meal
Secondary outcomes:
measure: Total beverage calories ordered at the dinner meal
timeFrame: Immediately after Day 1 test dinner meal
measure: Total beverage calories consumed at the dinner meal
timeFrame: Immediately after Day 1 test dinner meal
measure: Total food calories ordered at the dinner meal
timeFrame: Immediately after Day 1 test dinner meal
measure: Total food calories consumed at the dinner meal
timeFrame: Immediately after Day 1 test dinner meal
measure: Total calories consumed after the dinner meal
timeFrame: 24-hours post-Day 1 test dinner meal
measure: Combination of calories consumed at dinner & post-dinner
timeFrame: From immediately after Day 1 test dinner meal until 24-hours post Day 1 dinner meal
Other outcomes:
measure: Overall satisfaction with the price of the food item/s ordered: 7-point Likert item
timeFrame: Immediately after Day 1 test dinner meal
measure: Overall satisfaction with the portion of the food item/s ordered: 7-point Likert item
timeFrame: Immediately after Day 1 test dinner meal
measure: Satisfaction with drink size
timeFrame: Immediately after Day 1 test dinner meal
measure: Pre-meal hunger
timeFrame: Immediately after Day 1 test dinner meal
Locations:
Study officials:
affiliation: University of Pennsylvania
name: Christina A Roberto, PhD
role: STUDY_DIRECTOR
References: