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Reducing Sugar-sweetened Beverage Consumption Among Children

Primary Purpose

Pediatric Obesity, Diet, Food, and Nutrition

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Commercially-available caffeine-free soda
Carbonated water
Regular soda
Sponsored by
George Washington University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pediatric Obesity focused on measuring sugar-sweetened beverages, caffeine withdrawal, beverages, obesity

Eligibility Criteria

8 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Reports regular consumption of caffeinated sugar-sweetened beverages, defined as consuming ≥ 12 ounces of caffeinated SSB's per day

Exclusion Criteria:

  • Poorly managed chronic medical condition; current or prior eating order diagnosis; asthma requiring medication in past three months; history of migraines; regular consumption (≥ 1 serving per week) of other caffeinated beverages, such as energy drinks, regular coffee, or hot tea

Sites / Locations

  • Milken Institute School of Public Health and GW Medical Faculty Associates

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Caffeine-free Soda

Carbonated Water

Regular Soda

Arm Description

Consumption of caffeine-free soda daily for two weeks

Consumption of unsweetened, carbonated water daily for two weeks

Consumption of regular soda daily for two weeks

Outcomes

Primary Outcome Measures

Adherence
Adherence will be assessed by summing the number of study beverages consumed each day over the course of the intervention.
Withdrawal Symptoms
We will assess caffeine withdrawal symptoms using a child-adapted version of the validated caffeine withdrawal symptoms questionnaire (CWSQ). Participant responses to the CWSQ are on a Likert scale, where a score of "0" is not at all and "4" is "extremely"

Secondary Outcome Measures

Full Information

First Posted
July 10, 2019
Last Updated
May 11, 2022
Sponsor
George Washington University
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1. Study Identification

Unique Protocol Identification Number
NCT04025060
Brief Title
Reducing Sugar-sweetened Beverage Consumption Among Children
Official Title
Investigating Withdrawal Symptoms as Barriers to Reducing Sugar-sweetened Beverage Consumption Among Children
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
July 10, 2019 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
George Washington University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Lowering sugar-sweetened beverage (SSB) consumption is a central component of lifestyle behavior change aimed at preventing and managing obesity, yet effective reduction of SSB intakes has been met with many challenges. While their palatability, accessibility, publicity, affordability, and social acceptability contribute to frequent and sustained SSB consumption, their caffeine and sugar content may further encourage continued intake. Although adverse health consequences of excessive SSB consumption are well documented, the extent to which their pleasant taste (due primarily to their sugar content) and post-ingestive effects (due to their sugar and/or caffeine content) positively reinforce consumption among children has not been elucidated. The purpose of this study is to conduct a pilot intervention to examine the feasibility of removing caffeinated SSBs from the child diet and to explore whether caffeinated SSB removal induces withdrawal symptoms in 8-11 (3rd-5th grade) year old children. Participants will be randomly assigned to replace their usual caffeinated SSB consumption with either caffeinated SSBs, caffeine-free SSBs or sparkling water provided by the study team for two weeks.
Detailed Description
Sugar-sweetened beverages (SSBs) significantly contribute to sugar and calorie intakes, and their consumption is associated with metabolic disease. Sweetened beverages also account for the majority of pediatric caffeine consumption. It is well-established that habitual caffeine use leads to dependence in adults and evidence for sugar dependence has been documented. However, caffeine and/or sugar dependence related to sweetened beverage consumption has not been evaluated, and determinants of their consumption among youth are severely understudied. It is critical to elucidate whether they may be physiologically or psychologically dependent on these beverages, particularly SSBs, which contain both caffeine and sugar. The purpose of this study is to conduct a pilot study where caffeinated SSB's are replaced with caffeinated SSBs provided by the study team (control) or with caffeine-free and unsweetened alternatives (also provided by the study team) for 2 weeks, among children who habitually consume caffeinated SSBs. Lowering SSB consumption is a central component of lifestyle behavior change aimed at preventing and managing obesity, yet effective reduction of SSB intakes has been met with many challenges. While their palatability, accessibility, publicity, affordability, and social acceptability contribute to frequent and sustained SSB consumption, their caffeine and sugar content may further encourage continued intake. Although adverse health consequences of excessive SSB consumption are well documented, the extent to which their pleasant taste (due primarily to their sugar content) and post-ingestive effects (due to their sugar and/or caffeine content) positively reinforce consumption among children has not been elucidated. This is particularly important to study among children from low-income and minority backgrounds, as these children have the highest rates of SSB intake and the highest prevalence of obesity. Specific Aims and Hypotheses: Examine the feasibility of an intervention to remove caffeinated SSB from the child diet. We hypothesize that caffeinated SSB avoidance will be feasible among children, but that compliance will be lowest among those assigned to sparkling water, devoid of both caffeine and sugar. Compliance with beverage assignments will be assessed using daily online questionnaires and weekly dietary recalls. Explore the extent to which caffeinated SSB removal induces withdrawal symptoms. We hypothesize that replacement of caffeinated SSBs with caffeine-free SSBs, or sparkling water will induce withdrawal symptoms compared to control (usual caffeinated SSB consumption). Participants will complete a child-adapted version of the validated Caffeine Withdrawal Symptoms Questionnaire (CWSQ) at baseline and daily (online) during the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity, Diet, Food, and Nutrition
Keywords
sugar-sweetened beverages, caffeine withdrawal, beverages, obesity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Caffeine-free Soda
Arm Type
Experimental
Arm Description
Consumption of caffeine-free soda daily for two weeks
Arm Title
Carbonated Water
Arm Type
Experimental
Arm Description
Consumption of unsweetened, carbonated water daily for two weeks
Arm Title
Regular Soda
Arm Type
Active Comparator
Arm Description
Consumption of regular soda daily for two weeks
Intervention Type
Behavioral
Intervention Name(s)
Commercially-available caffeine-free soda
Intervention Description
Subjects are asked to consume caffeine-free soda daily for two weeks
Intervention Type
Behavioral
Intervention Name(s)
Carbonated water
Intervention Description
Subjects are asked to consume unsweetened, carbonated water daily for two weeks
Intervention Type
Behavioral
Intervention Name(s)
Regular soda
Intervention Description
Subjects are asked to consume regular soda daily for two weeks
Primary Outcome Measure Information:
Title
Adherence
Description
Adherence will be assessed by summing the number of study beverages consumed each day over the course of the intervention.
Time Frame
Two weeks
Title
Withdrawal Symptoms
Description
We will assess caffeine withdrawal symptoms using a child-adapted version of the validated caffeine withdrawal symptoms questionnaire (CWSQ). Participant responses to the CWSQ are on a Likert scale, where a score of "0" is not at all and "4" is "extremely"
Time Frame
Average withdrawal scores over first 72 hours of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Reports regular consumption of caffeinated sugar-sweetened beverages, defined as consuming ≥ 12 ounces of caffeinated SSB's per day Exclusion Criteria: Poorly managed chronic medical condition; current or prior eating order diagnosis; asthma requiring medication in past three months; history of migraines; regular consumption (≥ 1 serving per week) of other caffeinated beverages, such as energy drinks, regular coffee, or hot tea
Facility Information:
Facility Name
Milken Institute School of Public Health and GW Medical Faculty Associates
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20052
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Reducing Sugar-sweetened Beverage Consumption Among Children

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