Dietary Added Sugar ConsumptionASUsugarLIANCT05823597
Reducing Dietary Added-Sugar Consumption During the Transition to College
A study testing Sugar Intensive Treatment in people with Dietary Added Sugar Consumption, run by Arizona State University at 1 site in United States.
Trial summary
The goal of this cluster randomized controlled trial was to compare the effects of two single-session interventions (sugar-intensive vs. general health control) on added sugar intake, motivation to reduce sugar consumption, and factual knowledge about added sugar 6 weeks later, in a sample of first-semester… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dietary Added Sugar Consumption
- What is being tested?
- Sugar Intensive Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 702 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2020to 30 Oct 2020
- 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
- Students aged 18 years and older, enrolled in online sections of a required transition-to-college course at a large public university in the Southwest region of the U.S. All students in online sections of this class received the single-session intervention during their normal class period, early in the Fall 2020 semester, and were eligible to participate.
Who cannot join
- Age < 18 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Novel Intervention to Reduce Dietary Added-Sugar Consumption During the Transition to College: A Cluster Randomized Controlled Trial
The goal of this cluster randomized controlled trial was to compare the effects of two single-session interventions (sugar-intensive vs. general health control) on added sugar intake, motivation to reduce sugar consumption, and factual knowledge about added sugar 6 weeks later, in a sample of first-semester undergraduates.
Read the detailed description
Excessive sugar consumption is recognized as a critical public health concern. For many young adults, the transition to college presents both risk and a promising opportunity to encourage formation of healthy dietary habits. Capitalizing on this window of opportunity, we conducted a cluster-randomized controlled trial to compare the effects of two single-session interventions on added sugar intake in a sample of first-semester undergraduates. Participants received either an intervention primarily focused on reducing added sugar consumption or a general health behavior intervention with units on physical activity, sleep, and healthy diet. Participants' added sugar intake, motivation to reduce sugar consumption, and factual knowledge about added sugar intake were compared at follow-up.
- Conditions
- Dietary Added Sugar Consumption
- Being tested
- Sugar Intensive Treatment, General Health Control
- Keywords
- added sugar, eating behavior
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugar Intensive TreatmentBehavioural
see arm description
General Health ControlBehavioural
see arm description
| Study group | Role | What they receive |
|---|---|---|
| Sugar Intensive Treatment | Experimental | The Sugar-Intensive Intervention touched on exercise, sleep, and other aspects of healthy diet, but focused primarily on added sugar reduction. Beyond defining added sugar, the sugar-intensive intervention also included: information on how sugar is metabolized; description of health risks associated with excessive added sugar; opportunities to rehearse women's and men's recommended daily maxima; a game guessing the sugar content of various foods and beverages; information on proportion of undergraduates at their university who report being motivated to reduce their sugar intake; training in finding added-sugar information in nutritional labels; and concrete suggestions for replacing high-sugar foods and beverages with healthy options, and managing tempting situations. Receives: Behavioral: Sugar Intensive Treatment |
| General Health Control | Active comparator | The General Health Intervention presentation covered Healthy People 2030 goals regarding physical activity (aerobic exercise, strength training), healthy eating (fruit, vegetable, and whole grain consumption; decreasing consumption of saturated fats and added sugar), and sleep (minimum of 7 hours per night), as well as healthy stress management/emotion regulation. The health benefits/risks associated with each goal were described, along with suggested strategies for achieving each goal. This version of the intervention also included a definition of added sugar and information about the recommended daily added-sugar maxima for women and men, but served mainly as an active control condition for testing the effects of the target intervention of interest. Receives: Behavioral: General Health Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Added-Sugar Consumption at 6 Weeks
Change from baseline in consumption of specific high-sugar foods and beverages each day during the week preceding assessment. Using a matrix with days as columns and food/beverage items as rows, participants reported number of servings consumed of each food per day of that week: regular soda/pop/sweet iced tea (12oz), energy drinks (1 can), fully sweetened sports drinks (12oz), sugar-syrup coffee drinks (small = 8-12 oz = 1 serving; med = 1.5 servings; large = 2 servings), mixed drinks/cocktails (1 drink), donut/sweet pastry/danish (1 whole), muffin/cake-type bread slice (1 whole), fresh flavored yogurt (½ cup), cookie/brownie (3 oz), cupcake/slice of cake (1 whole), slice of pie (1 whole), ice cream/frozen yogurt (½ cup), and candy (¼ cup). Servings were multiplied by grams added sugar/serving for each item based on the National Cancer Institute Dietary Health Questionnaire-III, and summed across items to obtain total weekly added sugar.
Measured: 6 weeks post-intervention
Secondary outcomes (4)
Motivation to reduce added-sugar consumption
"How motivated are you to reduce your added-sugar consumption?" Response options were 1 = Not at all motivated, 2 = A little motivated, 3 = Somewhat motivated, and 4 = Very motivated.
Measured: 6 weeks post-intervention
Added sugar factual knowledge
Participants' knowledge of factual information regarding added sugar was assessed through three sets of questions. The first set of knowledge checks included eight statements about added sugar that participants marked as true or false (e.g., "Glucose is the primary fuel used by the human body"); the number of correct answers was summed. Second, participants were presented with a list of 12 ingredients (e.g., aspartame, honey, stevia) and asked to report whether each ingredient counts as added sugar; again, number of correct answers was summed. Third, participants were asked to state the maximum grams of added sugar per day recommended by the American Heart Association, separately for women and men, as presented in the intervention.
Measured: 6 weeks post-intervention
Change from Baseline Sleep at 6 Weeks
Participants indicated the amount of sleep they got, in hours, for each of the last seven nights. Participants were presented with seven text boxes labeled "7 days ago", "6 days ago" … "Last night," and asked to fill in the number of hours slept for each. Responses were averaged to obtain a single hours/night score.
Measured: 6 weeks post-intervention
Change from Baseline Exercise at 6 Weeks
Exercise was defined for participants as "any physical activity that gets the heart working much faster, makes you break a sweat, and/or requires a lot of muscle effort." Participants indicated the amount of exercise they got for each of the last seven days; response options for each day were: "none", "15 minutes", "30 minutes", "45 minutes", "60 minutes", and "more than 60 minutes." Responses were averaged to obtain a single minutes/day score.
Measured: 6 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start8 Sep 2020
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary Added Sugar ConsumptionStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- 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
- Cluster-randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 702 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823597
- Sponsor's protocol ID
- ASU SugarStudy LIA101
- Acronym
- ASUsugarLIA
- Status last verified
- Apr 2023
- First submitted
- 27 Mar 2023
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data, study protocol, and analytic code will be made publicly available via OSF upon acceptance of the first manuscript for publication.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Novel Intervention to Reduce Dietary Added-Sugar Consumption During the Transition to College: A Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05823597
- Acronym / sponsor ID
- ASUsugarLIA / ASU SugarStudy LIA101
- Conditions
- Dietary Added Sugar Consumption
- Keywords
- added sugar, eating behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 702 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 21 Apr 2023 (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.
The goal of this cluster randomized controlled trial was to compare the effects of two single-session interventions (sugar-intensive vs. general health control) on added sugar intake, motivation to reduce sugar consumption, and factual knowledge about added sugar 6 weeks later, in a sample of first-semester undergraduates.
Detailed description
Excessive sugar consumption is recognized as a critical public health concern. For many young adults, the transition to college presents both risk and a promising opportunity to encourage formation of healthy dietary habits. Capitalizing on this window of opportunity, we conducted a cluster-randomized controlled trial to compare the effects of two single-session interventions on added sugar intake in a sample of first-semester undergraduates. Participants received either an intervention primarily focused on reducing added sugar consumption or a general health behavior intervention with units on physical activity, sleep, and healthy diet. Participants' added sugar intake, motivation to reduce sugar consumption, and factual knowledge about added sugar intake were compared at follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Cluster-randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Sugar Intensive Treatment | Experimental | Behavioral: Sugar Intensive TreatmentThe Sugar-Intensive Intervention touched on exercise, sleep, and other aspects of healthy diet, but focused primarily on added sugar reduction. Beyond defining added sugar, the sugar-intensive intervention also included: information on how sugar is metabolized; description of health risks associated with excessive added sugar; opportunities to rehearse women's and men's recommended daily maxima; a game guessing the sugar content of various foods and beverages; information on proportion of undergraduates at their university who report being motivated to reduce their sugar intake; training in finding added-sugar information in nutritional labels; and concrete suggestions for replacing high-sugar foods and beverages with healthy options, and managing tempting situations. |
| General Health Control | Active comparator | Behavioral: General Health ControlThe General Health Intervention presentation covered Healthy People 2030 goals regarding physical activity (aerobic exercise, strength training), healthy eating (fruit, vegetable, and whole grain consumption; decreasing consumption of saturated fats and added sugar), and sleep (minimum of 7 hours per night), as well as healthy stress management/emotion regulation. The health benefits/risks associated with each goal were described, along with suggested strategies for achieving each goal. This version of the intervention also included a definition of added sugar and information about the recommended daily added-sugar maxima for women and men, but served mainly as an active control condition for testing the effects of the target intervention of interest. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Students aged 18 years and older, enrolled in online sections of a required transition-to-college course at a large public university in the Southwest region of the U.S. All students in online sections of this class received the single-session intervention during their normal class period, early in the Fall 2020 semester, and were eligible to participate.
Key exclusion criteria (1 listed)
- Age < 18 years.
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 |
|---|---|---|
| Sugar Intensive Treatmentsee arm description | Behavioural | Sugar Intensive Treatment |
| General Health Controlsee arm description | Behavioural | General Health Control |
Primary outcome
Change from Baseline Added-Sugar Consumption at 6 Weeks
Time frame: 6 weeks post-intervention
Change from baseline in consumption of specific high-sugar foods and beverages each day during the week preceding assessment. Using a matrix with days as columns and food/beverage items as rows, participants reported number of servings consumed of each food per day of that week: regular soda/pop/sweet iced tea (12oz), energy drinks (1 can), fully sweetened sports drinks (12oz), sugar-syrup coffee drinks (small = 8-12 oz = 1 serving; med = 1.5 servings; large = 2 servings), mixed drinks/cocktails (1 drink), donut/sweet pastry/danish (1 whole), muffin/cake-type bread slice (1 whole), fresh flavored yogurt (½ cup), cookie/brownie (3 oz), cupcake/slice of cake (1 whole), slice of pie (1 whole), ice cream/frozen yogurt (½ cup), and candy (¼ cup). Servings were multiplied by grams added sugar/serving for each item based on the National Cancer Institute Dietary Health Questionnaire-III, and summed across items to obtain total weekly added sugar.
4 secondary outcomes
Motivation to reduce added-sugar consumption
Time frame: 6 weeks post-intervention
Added sugar factual knowledge
Time frame: 6 weeks post-intervention
Change from Baseline Sleep at 6 Weeks
Time frame: 6 weeks post-intervention
Change from Baseline Exercise at 6 Weeks
Time frame: 6 weeks post-intervention
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 21 Apr 2023.
- Individual participant dataSharing planned: Yes. Anonymized data, study protocol, and analytic code will be made publicly available via OSF upon acceptance of the first manuscript for publication.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sugar Intensive Treatment in people with Dietary Added Sugar Consumption, run by Arizona State University at 1 site in United States.
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 1 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 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change from Baseline Added-Sugar Consumption at 6 Weeks (time frame: 6 weeks post-intervention). 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 21 Apr 2023.