NCT02044757

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 24, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

December 9, 2014

Status Verified

December 1, 2014

Enrollment Period

1.2 years

First QC Date

January 22, 2014

Last Update Submit

December 8, 2014

Conditions

Withdrawal Symptoms

Keywords

CaffeineAddictionWithdrawal symptomsPediatricAdolescentOverweight

Outcome Measures

Primary Outcomes (1)

  • 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.

    Days 1-3 and days 6-8

Secondary Outcomes (4)

  • Change in diet

    Days 1-2, 6-8

  • Change in impulsivity

    Days 1 and 8

  • Change in stress

    Days 1 and 8

  • Change in preference for soda

    Days 1-3, 6-8

Other Outcomes (1)

  • Compliance with intervention to only drink water and unflavored milk during the SSB withdrawal phase

    Days 6-8

Study Arms (1)

SSB withdrawal

EXPERIMENTAL
Behavioral: SSB withdrawal

Interventions

SSB withdrawalBEHAVIORAL

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).

SSB withdrawal

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant or nursing
  • Taking medication to address mental health issues

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital and Reasearch Center Oakland

Oakland, California, 94609, United States

Location

MeSH Terms

Conditions

Substance Withdrawal SyndromeBehavior, AddictiveOverweight

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersCompulsive BehaviorImpulsive BehaviorBehaviorOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kristine A Madsen, MD, MPH

    University of California, Berkeley School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2014

First Posted

January 24, 2014

Study Start

June 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

December 9, 2014

Record last verified: 2014-12

Locations

US(1)