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出境医 / 临床实验 / Reducing Sugar-sweetened Beverage Consumption Among Children

Reducing Sugar-sweetened Beverage Consumption Among Children

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.

Condition or disease Intervention/treatment Phase
Pediatric Obesity Diet, Food, and Nutrition Behavioral: Commercially-available caffeine-free soda Behavioral: Carbonated water Behavioral: Regular soda Not Applicable

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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Investigating Withdrawal Symptoms as Barriers to Reducing Sugar-sweetened Beverage Consumption Among Children
Actual Study Start Date : July 10, 2019
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Caffeine-free Soda
Consumption of caffeine-free soda daily for two weeks
Behavioral: Commercially-available caffeine-free soda
Subjects are asked to consume caffeine-free soda daily for two weeks

Experimental: Carbonated Water
Consumption of unsweetened, carbonated water daily for two weeks
Behavioral: Carbonated water
Subjects are asked to consume unsweetened, carbonated water daily for two weeks

Active Comparator: Regular Soda
Consumption of regular soda daily for two weeks
Behavioral: Regular soda
Subjects are asked to consume regular soda daily for two weeks

Outcome Measures
Primary Outcome Measures :
  1. Adherence [ Time Frame: Two weeks ]
    Adherence will be assessed by summing the number of study beverages consumed each day over the course of the intervention.

  2. Withdrawal Symptoms [ 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"


Eligibility Criteria
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Ages Eligible for Study:   8 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Locations
Layout table for location information
United States, District of Columbia
Milken Institute School of Public Health and GW Medical Faculty Associates Recruiting
Washington, District of Columbia, United States, 20052
Contact: Allison Sylvetsky    202-994-5602    asylvets@gwu.edu   
Sponsors and Collaborators
George Washington University
Tracking Information
First Submitted Date  ICMJE July 10, 2019
First Posted Date  ICMJE July 18, 2019
Last Update Posted Date August 20, 2020
Actual Study Start Date  ICMJE July 10, 2019
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2019)
  • Adherence [ Time Frame: Two weeks ]
    Adherence will be assessed by summing the number of study beverages consumed each day over the course of the intervention.
  • Withdrawal Symptoms [ 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"
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reducing Sugar-sweetened Beverage Consumption Among Children
Official Title  ICMJE Investigating Withdrawal Symptoms as Barriers to Reducing Sugar-sweetened Beverage Consumption Among Children
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE
  • Pediatric Obesity
  • Diet, Food, and Nutrition
Intervention  ICMJE
  • Behavioral: Commercially-available caffeine-free soda
    Subjects are asked to consume caffeine-free soda daily for two weeks
  • Behavioral: Carbonated water
    Subjects are asked to consume unsweetened, carbonated water daily for two weeks
  • Behavioral: Regular soda
    Subjects are asked to consume regular soda daily for two weeks
Study Arms  ICMJE
  • Experimental: Caffeine-free Soda
    Consumption of caffeine-free soda daily for two weeks
    Intervention: Behavioral: Commercially-available caffeine-free soda
  • Experimental: Carbonated Water
    Consumption of unsweetened, carbonated water daily for two weeks
    Intervention: Behavioral: Carbonated water
  • Active Comparator: Regular Soda
    Consumption of regular soda daily for two weeks
    Intervention: Behavioral: Regular soda
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 16, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2021
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04025060
Other Study ID Numbers  ICMJE NCR191271
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party George Washington University
Study Sponsor  ICMJE George Washington University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account George Washington University
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP