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CHOICES: Family Physicians Treat Overweight Children (CHOICES)

Primary Purpose

Obesity, Overweight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Choices
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Pediatric obesity, resiliency, physical activity, dietary patterns, children

Eligibility Criteria

8 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Conditions that would preclude dietary change or physical activity.

Sites / Locations

  • University of Arizona

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Choices

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

weight for age-and-gender specific Z-score

Full Information

First Posted
May 18, 2008
Last Updated
August 27, 2012
Sponsor
University of Arizona
Collaborators
National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT01674920
Brief Title
CHOICES: Family Physicians Treat Overweight Children
Acronym
CHOICES
Official Title
CHOICES: Family Physicians Treat Overweight Children
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona
Collaborators
National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The specific aim of this pilot study was to use the group office visit model to provide an obesity treatment intervention for children 8-11 years of age in gender-specific groups and their parents in a clinic setting. The targeted lifestyle components of the intervention are less TV viewing, less sweetened beverages, smaller food portions, less fast food/better choices away from home and more general physical activity. The psychosocial component was based in Resiliency; the Choices model focused on a non-judgmental approach to empowerment in relation to personal goals and knowledge of the basics of nutrition and physical activity. Our aim was to recruit 35-40 children (approximately equal boys and girls) ages 8-11 and their parents for a 12 weekly sessions group office visit program. Participants were randomized into 2 groups; one group starting in March 2006 and the lagged intervention control group starting in September 2006. Physical measurements and data collection were at baseline, 4, 8, 12, 16 months from randomization. We evaluated the acceptability and feasibility of the group office visit model and effect size (body mass index (BMI) and weight-for-age Z-scores). Feasibility and acceptability included ability to recruit within clinics, attendance, completion, follow-up rates, focus groups data and interviews of those who drop out. Evaluation of effect size included the patterns of growth over 15 months from baseline in relation to expected growth patterns and intervention exposure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
Pediatric obesity, resiliency, physical activity, dietary patterns, children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Choices
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Choices
Other Intervention Name(s)
Resiliency, Nutrition, Physical Activity
Intervention Description
The 12-week intervention included 1.5 hour classes each week. Topics included nutrition, physical activity, and psychosocial skills based in Resiliency.
Primary Outcome Measure Information:
Title
body mass index age-and-gender specific Z-score
Description
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.
Time Frame
9 months post intervention baseline
Secondary Outcome Measure Information:
Title
weight for age-and-gender specific Z-score
Time Frame
9 months post-intervention baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children in the 3rd to 5th grades and above the 85th percentile of BMI for age. Exclusion Criteria: Conditions that would preclude dietary change or physical activity.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheryl K Ritenbaugh, PhD, MPH
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States

12. IPD Sharing Statement

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CHOICES: Family Physicians Treat Overweight Children

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