Beverage Choice and Lifestyle Modification in Overweight Youth

Obesity Clinical Trial

Official title:

Beverage Choice and Lifestyle Modification in Overweight Youth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01662570
• Other study ID #: 807775
• Secondary ID: R21DK079075
• Status: Completed
• Phase: N/A
• First received: August 7, 2012
• Last updated: August 14, 2012
• Start date: March 2008
• Est. completion date: January 2011

Study information

• Verified date: November 2011
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: January 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 8 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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.

Locations

Country	Name	City	State
United States	University of Pennsylvania Center for Weight and Eating Disorders	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass Index (BMI)	Change in BMI will be measured from baseline to end of treatment (month 6).	Baseline and Month 6	No
Primary	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	No
Primary	Body Mass Index Percentile (BMI%)	Change in BMI% will be measured from baseline to end of treatment (month 6).	Baseline and Month 6	No
Primary	Child percent overweight	Change in child percent overweight will be measured from baseline to end of treatment (month 6).	Baseline and Month 6	No
Primary	Waist Circumference	Change in waist circumference will be measured from baseline to end of treatment (month 6).	Baseline to Month 6	No
Primary	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	No
Primary	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	No
Primary	Treatment acceptance and satisfaction	Overall treatment acceptance and satisfaction will be measured at end of treatment.	Month 6	No
Secondary	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	No