Beverage Choice and Lifestyle Modification in Overweight Youth
2 other identifiers
interventional
65
1 country
1
Brief Summary
The rise in childhood overweightness and concomitant increase in chronic disease risk warrants exploration into the effectiveness of interventions targeting the eating and activity habits of overweight youth. This research study developed and tested a "Beverage Choice and Lifestyle Modification" (BCLM) intervention for 4 to 8 year old children who are at-risk for being overweight or are overweight and who consume large amounts of sugar sweetened beverages and juice. The overall study objectives were to test the acceptability and effectiveness of the BCLM intervention for improving the weight status, energy (kcal) intake, beverage selections and beverage preferences of children in targeted age and BMI group. The investigators hypothesized that those children randomized to the BCLM group will show greater improvements in weight and Body Mass Index (BMI) status, beverage choices,and energy intake than those assigned to our Nutrition Education (NE) group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Mar 2008
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 7, 2012
CompletedFirst Posted
Study publicly available on registry
August 10, 2012
CompletedAugust 15, 2012
November 1, 2011
2.8 years
August 7, 2012
August 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Body Mass Index (BMI)
Change in BMI will be measured from baseline to end of treatment (month 6).
Baseline and Month 6
Body Mass Index z-score (BMI-z)
Change in BMI-z will be measured from baseline to end of treatment (month 6).
Baseline and month 6
Body Mass Index Percentile (BMI%)
Change in BMI% will be measured from baseline to end of treatment (month 6).
Baseline and Month 6
Child percent overweight
Change in child percent overweight will be measured from baseline to end of treatment (month 6).
Baseline and Month 6
Waist Circumference
Change in waist circumference will be measured from baseline to end of treatment (month 6).
Baseline to Month 6
Energy (kcal) intake
Change in energy intake (kcals/day) will be measured from baseline to end of treatment (month 6) using 3-day food diaries.
Baseline to Month 6
Sugar-sweetened beverage intake
Change in sugar-sweetened beverage intake will be measured from baseline to end of treatment (month 6).
Baseline to Month 6
Treatment acceptance and satisfaction
Overall treatment acceptance and satisfaction will be measured at end of treatment.
Month 6
Secondary Outcomes (1)
Child preferences and motivation for sugar-sweetened beverages
Baseline and Month 6
Study Arms (2)
Beverage Choice Lifestyle Modification
ACTIVE COMPARATORThe family-based BCLM intervention trained children and parents in self monitoring of sugar sweetened beverage intake and goal-setting, incorporated feedback and reinforcement, and provided water bottles and water filters to promote a reduction in sugar sweetened beverages and overall energy intake.
Nutrition Education (NE)
OTHERThis treatment for parents and children addressed a variety of topics in nutrition including benefits of fruits and vegetables, the food pyramid, vitamins, benefits of eating a variety of foods, and healthy beverage selections. No behavioral change training component was included.
Interventions
The family-based BCLM intervention trained children and parents in self monitoring of sugar sweetened beverage intake and goal-setting, incorporated feedback and reinforcement, and provided water bottles and water filters to promote a reduction in sugar sweetened beverages and overall energy intake. 16 sessions were provided over a 6-month period.
This treatment for parents and children addressed a variety of topics in nutrition including benefits of fruits and vegetables, the food pyramid, vitamins, benefits of eating a variety of foods, and healthy beverage selections. No behavioral change training component was included. 16 sessions over 24 weeks was provided.
Eligibility Criteria
You may qualify if:
- Ages 4-8 years old
- BMI≥85th percentile (based on age and sex)
- consumes large (≥16 oz.day) sugar sweetened beverages
You may not qualify if:
- Child has a serious medical condition
- Signs of elevated psychopathology are present, as assessed by the Child Behavior Checklist (CBCL)
- Parent demonstrates elevated psychiatric problems or eating disorders
- Failure of parent or child to meet BMI criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pennsylvania Center for Weight and Eating Disorders
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Myles S Faith, Ph.D.
University of Pennsylvania
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2012
First Posted
August 10, 2012
Study Start
March 1, 2008
Primary Completion
December 1, 2010
Study Completion
January 1, 2011
Last Updated
August 15, 2012
Record last verified: 2011-11