Health PolicyNCT04197063
Sugar-Sweetened Beverage Portion Limit Study
A study testing Sweetened beverage portion size limit in people with Health Policy, run by Rutgers, The State University of New Jersey.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Policy
- What is being tested?
- Sweetened beverage portion size limit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 359 participants
- Where
- No sites listed yet
- Study dates
- 14 Jan 2015to 27 Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults 18 years and older
- Ability to speak and read English
- Willing to participate and follow protocol specified activities
Who cannot join
- -Severe food allergies
About this study
Official title: 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).
Read the 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
- Being tested
- Sweetened beverage portion size limit
- Keywords
- sweetened beverage, portion size, policy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sweetened beverage portion size limitBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Current SSB restaurant portions purchase refill | Experimental | Offered a menu with current SSB restaurant portion sizes with the option to purchase refills Receives: 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 Receives: 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 Receives: 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 Receives: Behavioral: Sweetened beverage portion size limit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24-hours post-Day 1 test dinner meal
Secondary outcomes (6)
Total beverage calories ordered at the dinner meal
The beverages calorie content of beverage items was based on the nutritional information available online.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: From immediately after Day 1 test dinner meal until 24-hours post Day 1 dinner meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start14 Jan 2015
- Primary completion27 Aug 2015
- Study completion27 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health PolicyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 359 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pamela Rothpletz-Puglia, EdD, RD, Rutgers, The State University of New Jersey
- Investigators
- Christina A Roberto, PhD, Study director, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197063
- Sponsor's protocol ID
- Pro2019001933
- Status last verified
- Feb 2024
- First submitted
- 10 Oct 2019
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made publically available, upon request
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Portion Cap Policy on Sugar-Sweetened Beverages
- ClinicalTrials.gov ID
- NCT04197063
- Acronym / sponsor ID
- Pro2019001933
- Conditions
- Health Policy
- Keywords
- sweetened beverage, portion size, policy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 359 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 14 Jan 2015 (actual)
- Primary completion
- 27 Aug 2015 (actual)
- Study completion
- 27 Aug 2015 (actual)
- First posted
- 12 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Current SSB restaurant portions purchase refill | Experimental | Behavioral: Sweetened beverage portion size limitOffered a menu with current SSB restaurant portion sizes with the option to purchase refills |
| Current SSB restaurant portions free refill | Experimental | Behavioral: Sweetened beverage portion size limitOffered a menu with current SSB restaurant portion sizes plus free beverage refills |
| </= 16 oz. SSB portions with the option to purchase refills | Experimental | Behavioral: Sweetened beverage portion size limitOffered a menu with </= 16 oz. SSB portion sizes with the option to purchase refills |
| </= 16 oz. SSB portions plus free refills | Experimental | Behavioral: Sweetened beverage portion size limitOffered a menu with </= 16 oz. SSB portion sizes plus free refills |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults 18 years and older
- Ability to speak and read English
- Willing to participate and follow protocol specified activities
Key exclusion criteria (1 listed)
- -Severe food allergies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sweetened beverage portion size limit | Behavioural | </= 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 |
Primary outcome
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.
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.
6 secondary outcomes
Total beverage calories ordered at the dinner meal
Time frame: Immediately after Day 1 test dinner meal
Total beverage calories consumed at the dinner meal
Time frame: Immediately after Day 1 test dinner meal
Total food calories ordered at the dinner meal
Time frame: Immediately after Day 1 test dinner meal
Total food calories consumed at the dinner meal
Time frame: Immediately after Day 1 test dinner meal
Total calories consumed after the dinner meal
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: Yes. Data will be made publically available, upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina A Roberto, PhD study director
University of Pennsylvania
Questions about this trial
What is this clinical trial studying?
A study testing Sweetened beverage portion size limit in people with Health Policy, run by Rutgers, The State University of New Jersey.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.