Reducing Sugar-sweetened Beverage Consumption Among Children

NCT04025060 | Completed

• 1 other identifier: NCR191271
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Obesity; Diet, Food, and Nutrition

Keywords

sugar-sweetened beverages; caffeine withdrawal; beverages; obesity

Outcome Measures

Primary Outcomes (2)

• Adherence

  Adherence will be assessed by summing the number of study beverages consumed each day over the course of the intervention.

  Two weeks

• 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"

  Average withdrawal scores over first 72 hours of intervention

Study Arms (3)

Caffeine-free Soda

EXPERIMENTAL

Consumption of caffeine-free soda daily for two weeks

Behavioral: Commercially-available caffeine-free soda

Carbonated Water

EXPERIMENTAL

Consumption of unsweetened, carbonated water daily for two weeks

Behavioral: Carbonated water

Regular Soda

ACTIVE COMPARATOR

Consumption of regular soda daily for two weeks

Behavioral: Regular soda

Interventions

Commercially-available caffeine-free soda BEHAVIORAL

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

Caffeine-free Soda

Carbonated water BEHAVIORAL

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

Carbonated Water

Regular soda BEHAVIORAL

Subjects are asked to consume regular soda daily for two weeks

Regular Soda

Eligibility Criteria

• Age: 8 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• George Washington University: lead

Study Sites (1)

Milken Institute School of Public Health and GW Medical Faculty Associates

Washington D.C., District of Columbia, 20052, United States

Location

MeSH Terms

Conditions

Pediatric Obesity; Obesity

Interventions

Carbonated Water

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mineral Waters; Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Carbonated Beverages; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Drinking Water; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 18, 2019
• Study Start: July 10, 2019
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: May 12, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)