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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Beverage Choice and Lifestyle Modification in Overweight Youth

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


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

Ages Eligible for Study:   4 Years to 8 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Myles S Faith, Ph.D. University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01662570     History of Changes
Other Study ID Numbers: 807775, R21DK079075
Study First Received: August 7, 2012
Last Updated: August 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Pediatric Obesity
Child Overweight

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2014