Beverage Choice and Lifestyle Modification in Overweight Youth

NCT ID: NCT01662570

Last Updated: 2012-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Keywords

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Pediatric Obesity Child Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Beverage Choice and Lifestyle Modification

Intervention Type BEHAVIORAL

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.

Group Type OTHER

Nutrition Education (NE)

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Other Intervention Names

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NE

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Myles S Faith, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania Center for Weight and Eating Disorders

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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R21DK079075

Identifier Type: NIH

Identifier Source: secondary_id

View Link

807775

Identifier Type: -

Identifier Source: org_study_id