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Completed

NCT Number: NCT01662570

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania Center for Weight and Eating Disorders

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Beverage Choice and Lifestyle Modification

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)

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.

Other names: NE

Primary outcomes

  1. Body Mass Index (BMI)

    Time frame: Baseline and Month 6

    Change in BMI will be measured from baseline to end of treatment (month 6).

  2. Body Mass Index z-score (BMI-z)

    Time frame: Baseline and month 6

    Change in BMI-z will be measured from baseline to end of treatment (month 6).

  3. Body Mass Index Percentile (BMI%)

    Time frame: Baseline and Month 6

    Change in BMI% will be measured from baseline to end of treatment (month 6).

  4. Child percent overweight

    Time frame: Baseline and Month 6

    Change in child percent overweight will be measured from baseline to end of treatment (month 6).

  5. Waist Circumference

    Time frame: Baseline to Month 6

    Change in waist circumference will be measured from baseline to end of treatment (month 6).

  6. Energy (kcal) intake

    Time frame: Baseline to Month 6

    Change in energy intake (kcals/day) will be measured from baseline to end of treatment (month 6) using 3-day food diaries.

  7. Sugar-sweetened beverage intake

    Time frame: Baseline to Month 6

    Change in sugar-sweetened beverage intake will be measured from baseline to end of treatment (month 6).

  8. Treatment acceptance and satisfaction

    Time frame: Month 6

    Overall treatment acceptance and satisfaction will be measured at end of treatment.

Secondary outcomes

  1. Child preferences and motivation for sugar-sweetened beverages

    Time frame: Baseline and Month 6

    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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

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

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Aug 10, 2012
Registry last updated
Aug 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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