Beverage Choice and Lifestyle Modification in Overweight Youth

Study Overview
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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.

Official Title
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Beverage Choice and Lifestyle Modification in Overweight Youth

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Beverage Choice and Lifestyle Modification
* Other: Nutrition Education (NE)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Beverage Choice Lifestyle Modification<br>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<br>* 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.<br>|
| Other: Nutrition Education (NE)<br>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)<br>* 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.<br>* Other names: NE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index (BMI) | Change in BMI will be measured from baseline to end of treatment (month 6). | Baseline and Month 6 | 
| 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 | 
| Body Mass Index Percentile (BMI%) | Change in BMI% will be measured from baseline to end of treatment (month 6). | Baseline and Month 6 | 
| Child percent overweight | Change in child percent overweight will be measured from baseline to end of treatment (month 6). | Baseline and Month 6 | 
| Waist Circumference | Change in waist circumference will be measured from baseline to end of treatment (month 6). | Baseline to 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. | Baseline to Month 6 | 
| 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 | 
| Treatment acceptance and satisfaction | Overall treatment acceptance and satisfaction will be measured at end of treatment. | Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric Obesity, Child Overweight