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Beverage Choice and Lifestyle Modification in Overweight Youth

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01662570
First received: August 7, 2012
Last updated: August 14, 2012
Last verified: November 2011

August 7, 2012
August 14, 2012
March 2008
December 2010   (final data collection date for primary outcome measure)
  • Body Mass Index (BMI) [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    Change in BMI will be measured from baseline to end of treatment (month 6).
  • Body Mass Index z-score (BMI-z) [ Time Frame: Baseline and month 6 ] [ Designated as safety issue: No ]
    Change in BMI-z will be measured from baseline to end of treatment (month 6).
  • Body Mass Index Percentile (BMI%) [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    Change in BMI% will be measured from baseline to end of treatment (month 6).
  • Child percent overweight [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    Change in child percent overweight will be measured from baseline to end of treatment (month 6).
  • Waist Circumference [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
    Change in waist circumference will be measured from baseline to end of treatment (month 6).
  • Energy (kcal) intake [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
    Change in energy intake (kcals/day) will be measured from baseline to end of treatment (month 6) using 3-day food diaries.
  • Sugar-sweetened beverage intake [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
    Change in sugar-sweetened beverage intake will be measured from baseline to end of treatment (month 6).
  • Treatment acceptance and satisfaction [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Overall treatment acceptance and satisfaction will be measured at end of treatment.
  • BMI [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    Change in BMI will be measured from baseline to end of treatment (month 6).
  • BMI-z [ Time Frame: Baseline and month 6 ] [ Designated as safety issue: No ]
    Change in BMI-z will be measured from baseline to end of treatment (month 6).
  • BMI% [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    Change in BMI% will be measured from baseline to end of treatment (month 6).
  • Child percent overweight [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    Change in child percent overweight will be measured from baseline to end of treatment (month 6).
  • Waist Circumference [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
    Change in waist circumference will be measured from baseline to end of treatment (month 6).
  • Energy (kcal) intake [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
    Change in energy intake (kcals/day) will be measured from baseline to end of treatment (month 6) using 3-day food diaries.
  • Sugar-sweetened beverage intake [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
    Change in sugar-sweetened beverage intake will be measured from baseline to end of treatment (month 6).
  • Treatment acceptance and satisfaction [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Overall treatment acceptance and satisfaction will be measured at end of treatment.
Complete list of historical versions of study NCT01662570 on ClinicalTrials.gov Archive Site
Child preferences and motivation for sugar-sweetened beverages [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
Change in child preference and motivation for sugar-sweetened beverages will be measured from baseline to month 6 using a computerized behavioral choice task assessment.
Same as current
Not Provided
Not Provided
 
Beverage Choice and Lifestyle Modification in Overweight Youth
Beverage Choice and Lifestyle Modification in Overweight Youth

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Obesity
  • Behavioral: Beverage Choice and Lifestyle Modification
    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.
  • Other: Nutrition Education (NE)
    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.
    Other Name: NE
  • Active Comparator: Beverage Choice Lifestyle Modification
    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.
    Intervention: Behavioral: Beverage Choice and Lifestyle Modification
  • Nutrition Education (NE)
    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.
    Intervention: Other: Nutrition Education (NE)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
January 2011
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Ages 4-8 years old
  • BMI≥85th percentile (based on age and sex)
  • consumes large (≥16 oz.day) sugar sweetened beverages

Exclusion Criteria:

  • 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
Both
4 Years to 8 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01662570
807775, R21DK079075
No
University of Pennsylvania
University of Pennsylvania
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Myles S Faith, Ph.D. University of Pennsylvania
University of Pennsylvania
November 2011

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