Reducing Sugar-sweetened Beverage Consumption Among Children

NCT ID: NCT04025060

Last Updated: 2022-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-10
• Study Completion Date: 2021-05-31

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:

1. 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.

2. 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.

Conditions

Pediatric Obesity; Diet, Food, and Nutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Caffeine-free Soda

Consumption of caffeine-free soda daily for two weeks

Group Type: EXPERIMENTAL

Commercially-available caffeine-free soda

Intervention Type: BEHAVIORAL

Subjects are asked to consume caffeine-free soda daily for two weeks

Carbonated Water

Consumption of unsweetened, carbonated water daily for two weeks

Group Type: EXPERIMENTAL

Carbonated water

Intervention Type: BEHAVIORAL

Subjects are asked to consume unsweetened, carbonated water daily for two weeks

Regular Soda

Consumption of regular soda daily for two weeks

Group Type: ACTIVE_COMPARATOR

Regular soda

Intervention Type: BEHAVIORAL

Subjects are asked to consume regular soda daily for two weeks

Interventions

Commercially-available caffeine-free soda

Subjects are asked to consume caffeine-free soda daily for two weeks

Intervention Type: BEHAVIORAL

Carbonated water

Subjects are asked to consume unsweetened, carbonated water daily for two weeks

Intervention Type: BEHAVIORAL

Regular soda

Subjects are asked to consume regular soda daily for two weeks

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

George Washington University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Milken Institute School of Public Health and GW Medical Faculty Associates

Washington D.C., District of Columbia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

NCR191271

Identifier Type: -

Identifier Source: org_study_id