NCT01674920

Brief Summary

CHOICES is a program to provide children and families with lifetime tools and lifestyle strategies to achieve and maintain a healthy body size. Both parents and children get active, learn about the food choices they can make, and about the roles of TV in their lives. Led by physicians and young adults, the 12 weekly 90 minute sessions provide hands on experiences that connect into the participants' daily lives. In the study, the families were divided into two groups, beginning their classes 6 months apart. Body measurements were taken at baseline and every 4 months to 16 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jan 2006

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2008

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
4.2 years until next milestone

First Posted

Study publicly available on registry

August 29, 2012

Completed
Last Updated

August 29, 2012

Status Verified

August 1, 2012

Enrollment Period

1.4 years

First QC Date

May 18, 2008

Last Update Submit

August 27, 2012

Conditions

Keywords

Pediatric obesityresiliencyphysical activitydietary patternschildren

Outcome Measures

Primary Outcomes (1)

  • body mass index age-and-gender specific Z-score

    body mass index is weight over height squared; z-score described the position of that BMI in relation to the reference population in terms of standard deviation units. It is used to control for growth effects in children.

    9 months post intervention baseline

Secondary Outcomes (1)

  • weight for age-and-gender specific Z-score

    9 months post-intervention baseline

Study Arms (1)

Choices

EXPERIMENTAL

The 3-month twelve-session intervention, "Choices", included topics on nutrition, physical activity, and resiliency. Parents, boys and girls met separately. The sessions were developed for delivery by a family physician, two family medicine residents, and a nutritionist, who received training in positive psychology and resilience skills. All children were measured on the same dates, but children were randomly assigned to two cohorts, beginning 6 months apart, to facilitate statistical analysis by having one group experience "normal growth" on study prior to intervention.

Behavioral: Choices

Interventions

ChoicesBEHAVIORAL

The 12-week intervention included 1.5 hour classes each week. Topics included nutrition, physical activity, and psychosocial skills based in Resiliency.

Also known as: Resiliency, Nutrition, Physical Activity
Choices

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children in the 3rd to 5th grades and above the 85th percentile of BMI for age.

You may not qualify if:

  • Conditions that would preclude dietary change or physical activity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

ObesityOverweightPediatric ObesityMotor Activity

Interventions

Nutritional StatusExercise

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation CharacteristicsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Cheryl K Ritenbaugh, PhD, MPH

    University of Arizona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2008

First Posted

August 29, 2012

Study Start

January 1, 2006

Primary Completion

June 1, 2007

Study Completion

June 1, 2008

Last Updated

August 29, 2012

Record last verified: 2012-08

Locations