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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Beverage Choice and Lifestyle Modification; Other: Nutrition Education (NE)

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Center for Weight and Eating Disorders

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 8 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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.	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 Names: NE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child preferences and motivation for sugar-sweetened beverages	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.	Baseline and Month 6

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Myles S Faith, Ph.D., University of Pennsylvania

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: August 7, 2012
• First Submitted That Met QC Criteria: August 9, 2012
• First Posted (Estimate): August 10, 2012

Study Record Updates

• Last Update Posted (Estimate): August 15, 2012
• Last Update Submitted That Met QC Criteria: August 14, 2012
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: Pediatric Obesity; Child Overweight
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: 807775; R21DK079075 (U.S. NIH Grant/Contract)