Pediatric Obesity Clinical Trial
Official title:
Investigating Withdrawal Symptoms as Barriers to Reducing Sugar-sweetened Beverage Consumption Among Children
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT03994419 -
PErioperAtive CHildhood ObesitY
|
||
Recruiting |
NCT06111040 -
Nurturing Needs Study: Parenting Food Motivated Children
|
N/A | |
Completed |
NCT03036696 -
The BEACH Interview Study- Pregnant and Breastfeeding Mothers
|
||
Not yet recruiting |
NCT02484612 -
Exercise Intensity and Appetite in Adolescents
|
N/A | |
Completed |
NCT02959034 -
Pediatric Metabolism and Microbiome Repository
|
||
Completed |
NCT02545764 -
Training Induced Reduction of Lower-limb Joint Loads During Locomotion in Obese Children
|
N/A | |
Recruiting |
NCT02426346 -
A Scalable Weight Control Intervention for Adolescents
|
Phase 2 | |
Completed |
NCT01989065 -
Healthy Lifestyles Program for You (HLP4U): Augmenting Childhood Obesity Treatment.
|
N/A | |
Completed |
NCT02160847 -
Development of the DRIVE Curriculum to Address Childhood Obesity Risk Factors
|
N/A | |
Completed |
NCT01908153 -
Taste Reward Processing in Pediatric Obesity
|
||
Completed |
NCT02343588 -
A National School-based Health Lifestyles Interventions Among Chinese Children and Adolescents Against Obesity
|
N/A | |
Completed |
NCT02375490 -
Healthy Start to Increase Physical Activity and Improve Healthy Eating in Early Childcare Centres
|
N/A | |
Completed |
NCT02074332 -
Study on Obesity Intervention With Physical Exercise Among Students in Changping District, Beijing
|
N/A | |
Completed |
NCT02086851 -
Study of a Structured Parent Intervention on Adolescent Weight Loss Modification Program.
|
N/A | |
Completed |
NCT01146314 -
A Family Based Intervention to Reduce the Risk of Type 2 Diabetes in Children
|
N/A | |
Terminated |
NCT00846521 -
Study of Post-meal Blood Sugar Peaks in Association With Vascular Disease in Childhood Obesity
|
Phase 4 | |
Completed |
NCT04164277 -
FirstStep2Health Intervention
|
N/A | |
Withdrawn |
NCT04600648 -
Sweet Taste Responsiveness in Relation to Insulin, Leptin and Adiposity Among Obese Treatment Seeking Children
|
N/A | |
Completed |
NCT04395430 -
A Novel School-clinic-community Online Model of Child Obesity Treatment in Singapore During COVID-19
|
N/A | |
Completed |
NCT03139877 -
Pediatric Obesity Observational Prospective Trial
|