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Beverage Choice and Lifestyle Modification in Overweight Youth

Beverage Choice and Lifestyle Modification in Overweight Youth

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01662570
Enrollment
65
Registered
2012-08-10
Start date
2008-03-31
Completion date
2011-01-31
Last updated
2012-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Pediatric Obesity, Child Overweight

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.

Interventions

BEHAVIORALBeverage 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.

OTHERNutrition 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.

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Body Mass Index Percentile (BMI%)Baseline and Month 6Change in BMI% will be measured from baseline to end of treatment (month 6).
Child percent overweightBaseline and Month 6Change in child percent overweight will be measured from baseline to end of treatment (month 6).
Waist CircumferenceBaseline to Month 6Change in waist circumference will be measured from baseline to end of treatment (month 6).
Energy (kcal) intakeBaseline to Month 6Change in energy intake (kcals/day) will be measured from baseline to end of treatment (month 6) using 3-day food diaries.
Sugar-sweetened beverage intakeBaseline to Month 6Change in sugar-sweetened beverage intake will be measured from baseline to end of treatment (month 6).
Treatment acceptance and satisfactionMonth 6Overall treatment acceptance and satisfaction will be measured at end of treatment.
Body Mass Index (BMI)Baseline and Month 6Change in BMI will be measured from baseline to end of treatment (month 6).
Body Mass Index z-score (BMI-z)Baseline and month 6Change in BMI-z will be measured from baseline to end of treatment (month 6).

Secondary

MeasureTime frameDescription
Child preferences and motivation for sugar-sweetened beveragesBaseline and Month 6Change in child preference and motivation for sugar-sweetened beverages will be measured from baseline to month 6 using a computerized behavioral choice task assessment.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026