- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05823597
Reducing Dietary Added-Sugar Consumption During the Transition to College (ASUsugarLIA)
April 10, 2023 updated by: Arizona State University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
702
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Arizona
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Tempe, Arizona, United States, 85287
- Arizona State University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Age < 18 years.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sugar Intensive Treatment
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.
|
see arm description
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Active Comparator: General Health Control
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.
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see arm description
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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6 weeks post-intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motivation to reduce added-sugar consumption
Time Frame: 6 weeks post-intervention
|
"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.
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6 weeks post-intervention
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Added sugar factual knowledge
Time Frame: 6 weeks post-intervention
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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.
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6 weeks post-intervention
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Change from Baseline Sleep at 6 Weeks
Time Frame: 6 weeks post-intervention
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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.
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6 weeks post-intervention
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Change from Baseline Exercise at 6 Weeks
Time Frame: 6 weeks post-intervention
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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.
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6 weeks post-intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 8, 2020
Primary Completion (Actual)
October 30, 2020
Study Completion (Actual)
October 30, 2020
Study Registration Dates
First Submitted
March 27, 2023
First Submitted That Met QC Criteria
April 10, 2023
First Posted (Actual)
April 21, 2023
Study Record Updates
Last Update Posted (Actual)
April 21, 2023
Last Update Submitted That Met QC Criteria
April 10, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ASU SugarStudy LIA101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Anonymized data, study protocol, and analytic code will be made publicly available via OSF upon acceptance of the first manuscript for publication.
IPD Sharing Time Frame
Upon acceptance of the initial manuscript reporting study results for publication; permanently
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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