Back to resultsThe Potentially Addictive Properties of Soda: A Feasibility Study
Primary Purpose
Withdrawal Symptoms
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SSB withdrawal
Sponsored by
About this trial
This is an interventional supportive care trial for Withdrawal Symptoms focused on measuring Caffeine, Addiction, Withdrawal symptoms, Pediatric, Adolescent, Overweight
Eligibility Criteria
Inclusion Criteria:
- Drinks more than 36 ounces of sugar-sweetened beverages per day
- Speaks fluent English
- Parent speaks English or Spanish
- Lives in San Francisco Bay Area
Exclusion Criteria:
- Pregnant or nursing
- Taking medication to address mental health issues
Sites / Locations
- Children's Hospital and Reasearch Center Oakland
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SSB withdrawal
Arm Description
Outcomes
Primary Outcome Measures
Symptoms of withdrawal
Symptoms of withdrawal during the SSB withdrawal period (days 6-8) will be compared to symptoms of withdrawal during usual consumption period (days 1-3). Three measures are used to assess withdrawal symptoms: Griffiths' withdrawal scale, the relative reinforcing value of soda, and daily check in questions on well-being.
Secondary Outcome Measures
Change in diet
Changes in diet will be assessed by 24-hour dietary recalls and beverage recalls
Change in impulsivity
Impulsivity will be assessed via the delayed discounting task
Change in stress
Stress will be assessed via salivary cortisol samples
Change in preference for soda
Preference for soda will be measured through the Labeled Affective Magnitude Scale (LAMS) and daily check-in questions
Full Information
NCT ID
NCT02044757
First Posted
January 22, 2014
Last Updated
December 8, 2014
Sponsor
University of California, Berkeley
Collaborators
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT02044757
Brief Title
The Potentially Addictive Properties of Soda: A Feasibility Study
Official Title
The Potentially Addictive Properties of Soda: A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Berkeley
Collaborators
University of California, San Francisco
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study to investigate the addictive properties of soda and other sugar sweetened beverages (SBBs) in teenagers aged 13-18 years. It is hypothesized that participants who were regularly consuming sweetened and caffeinated beverages will experience symptoms typical of caffeine withdrawal, such as headache and fatigue, during the SSB withdrawal period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Withdrawal Symptoms
Keywords
Caffeine, Addiction, Withdrawal symptoms, Pediatric, Adolescent, Overweight
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SSB withdrawal
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
SSB withdrawal
Intervention Description
During days 1-5, participants will drink the beverages they normally consume (no intervention). On days 6-8, participants will be instructed to drink only water and unflavored milk during the withdrawal period (days 6-8).
Primary Outcome Measure Information:
Title
Symptoms of withdrawal
Description
Symptoms of withdrawal during the SSB withdrawal period (days 6-8) will be compared to symptoms of withdrawal during usual consumption period (days 1-3). Three measures are used to assess withdrawal symptoms: Griffiths' withdrawal scale, the relative reinforcing value of soda, and daily check in questions on well-being.
Time Frame
Days 1-3 and days 6-8
Secondary Outcome Measure Information:
Title
Change in diet
Description
Changes in diet will be assessed by 24-hour dietary recalls and beverage recalls
Time Frame
Days 1-2, 6-8
Title
Change in impulsivity
Description
Impulsivity will be assessed via the delayed discounting task
Time Frame
Days 1 and 8
Title
Change in stress
Description
Stress will be assessed via salivary cortisol samples
Time Frame
Days 1 and 8
Title
Change in preference for soda
Description
Preference for soda will be measured through the Labeled Affective Magnitude Scale (LAMS) and daily check-in questions
Time Frame
Days 1-3, 6-8
Other Pre-specified Outcome Measures:
Title
Compliance with intervention to only drink water and unflavored milk during the SSB withdrawal phase
Description
Using measure of salivary caffeine, beverage recalls, and 24-hour dietary recalls, we will assess compliance.
Time Frame
Days 6-8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Drinks more than 36 ounces of sugar-sweetened beverages per day
Speaks fluent English
Parent speaks English or Spanish
Lives in San Francisco Bay Area
Exclusion Criteria:
Pregnant or nursing
Taking medication to address mental health issues
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristine A Madsen, MD, MPH
Organizational Affiliation
University of California, Berkeley School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital and Reasearch Center Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Potentially Addictive Properties of Soda: A Feasibility Study
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