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Beverage Choice and Lifestyle Modification in Overweight Youth

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01662570
First Posted: August 10, 2012
Last Update Posted: August 15, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Pennsylvania
  Purpose
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.

Condition Intervention
Obesity Behavioral: Beverage Choice and Lifestyle Modification Other: Nutrition Education (NE)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Beverage Choice and Lifestyle Modification in Overweight Youth

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Body Mass Index (BMI) [ Time Frame: Baseline and Month 6 ]
    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 ]
    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 ]
    Change in BMI% will be measured from baseline to end of treatment (month 6).

  • Child percent overweight [ Time Frame: Baseline and Month 6 ]
    Change in child percent overweight will be measured from baseline to end of treatment (month 6).

  • Waist Circumference [ Time Frame: Baseline to Month 6 ]
    Change in waist circumference will be measured from baseline to end of treatment (month 6).

  • Energy (kcal) intake [ Time Frame: Baseline to Month 6 ]
    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 ]
    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 ]
    Overall treatment acceptance and satisfaction will be measured at end of treatment.


Secondary Outcome Measures:
  • Child preferences and motivation for sugar-sweetened beverages [ Time Frame: Baseline and Month 6 ]
    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.


Enrollment: 65
Study Start Date: March 2008
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01662570


Locations
United States, Pennsylvania
University of Pennsylvania Center for Weight and Eating Disorders
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Myles S Faith, Ph.D. University of Pennsylvania
  More Information

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01662570     History of Changes
Other Study ID Numbers: 807775
R21DK079075 ( U.S. NIH Grant/Contract )
First Submitted: August 7, 2012
First Posted: August 10, 2012
Last Update Posted: August 15, 2012
Last Verified: November 2011

Keywords provided by University of Pennsylvania:
Pediatric Obesity
Child Overweight

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms