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Beverage Choice and Lifestyle Modification in Overweight Youth

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Beverage Choice and Lifestyle Modification
Nutrition Education (NE)
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Pediatric Obesity, Child Overweight

Eligibility Criteria

4 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Pennsylvania Center for Weight and Eating Disorders

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Beverage Choice Lifestyle Modification

Nutrition Education (NE)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Body Mass Index (BMI)
Change in BMI will be measured from baseline to end of treatment (month 6).
Body Mass Index z-score (BMI-z)
Change in BMI-z will be measured from baseline to end of treatment (month 6).
Body Mass Index Percentile (BMI%)
Change in BMI% will be measured from baseline to end of treatment (month 6).
Child percent overweight
Change in child percent overweight will be measured from baseline to end of treatment (month 6).
Waist Circumference
Change in waist circumference will be measured from baseline to end of treatment (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.
Sugar-sweetened beverage intake
Change in sugar-sweetened beverage intake will be measured from baseline to end of treatment (month 6).
Treatment acceptance and satisfaction
Overall treatment acceptance and satisfaction will be measured at end of treatment.

Secondary Outcome Measures

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.

Full Information

First Posted
August 7, 2012
Last Updated
August 14, 2012
Sponsor
University of Pennsylvania
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT01662570
Brief Title
Beverage Choice and Lifestyle Modification in Overweight Youth
Official Title
Beverage Choice and Lifestyle Modification in Overweight Youth
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Pediatric Obesity, Child Overweight

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Beverage Choice Lifestyle Modification
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Nutrition Education (NE)
Arm Type
Other
Arm Description
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 Type
Behavioral
Intervention Name(s)
Beverage Choice and Lifestyle Modification
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Nutrition Education (NE)
Other Intervention Name(s)
NE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body Mass Index (BMI)
Description
Change in BMI will be measured from baseline to end of treatment (month 6).
Time Frame
Baseline and Month 6
Title
Body Mass Index z-score (BMI-z)
Description
Change in BMI-z will be measured from baseline to end of treatment (month 6).
Time Frame
Baseline and month 6
Title
Body Mass Index Percentile (BMI%)
Description
Change in BMI% will be measured from baseline to end of treatment (month 6).
Time Frame
Baseline and Month 6
Title
Child percent overweight
Description
Change in child percent overweight will be measured from baseline to end of treatment (month 6).
Time Frame
Baseline and Month 6
Title
Waist Circumference
Description
Change in waist circumference will be measured from baseline to end of treatment (month 6).
Time Frame
Baseline to Month 6
Title
Energy (kcal) intake
Description
Change in energy intake (kcals/day) will be measured from baseline to end of treatment (month 6) using 3-day food diaries.
Time Frame
Baseline to Month 6
Title
Sugar-sweetened beverage intake
Description
Change in sugar-sweetened beverage intake will be measured from baseline to end of treatment (month 6).
Time Frame
Baseline to Month 6
Title
Treatment acceptance and satisfaction
Description
Overall treatment acceptance and satisfaction will be measured at end of treatment.
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Child preferences and motivation for sugar-sweetened beverages
Description
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.
Time Frame
Baseline and Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myles S Faith, Ph.D.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania Center for Weight and Eating Disorders
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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Beverage Choice and Lifestyle Modification in Overweight Youth

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