Milken Institute School of Public Health and GW Medical Faculty Associates
Washington D.C., District of Columbia, 20052, United States
NCT Number: NCT04025060
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.
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Notify Me8 year–11 year
All sexes
Interventional
Not applicable
Washington D.C., District of Columbia, 20052, United States
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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects are asked to consume caffeine-free soda daily for two weeks
Subjects are asked to consume unsweetened, carbonated water daily for two weeks
Subjects are asked to consume regular soda daily for two weeks
Time frame: Two weeks
Adherence will be assessed by summing the number of study beverages consumed each day over the course of the intervention.
Time frame: Average withdrawal scores over first 72 hours of intervention
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"
George Washington University
Other
Investigating Withdrawal Symptoms as Barriers to Reducing Sugar-sweetened Beverage Consumption Among Children
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