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Gardner Packard Healthy Lifestyles Program

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gardner GOALS
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Obesity

Eligibility Criteria

6 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • BMI ≥ 95th percentile
  • Two clinic visits in 2020

Exclusion Criteria:

  • Signs of an eating disorder
  • Moved out of town and not planning to return to Gardner Packard Children's Health Center

Sites / Locations

  • Gardner Packard Children's Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Gardner GOALS

Control

Arm Description

Healthy lifestyle intervention by telehealth plus regular clinic visits

Regular clinic visits

Outcomes

Primary Outcome Measures

Body mass index
Change in trajectory of body mass index from the year prior to the intervention compared to the year after starting the intervention

Secondary Outcome Measures

Full Information

First Posted
October 20, 2021
Last Updated
September 22, 2022
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT05107648
Brief Title
Gardner Packard Healthy Lifestyles Program
Official Title
Gardner GOALS for Treatment of Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 6, 2021 (Actual)
Primary Completion Date
August 28, 2022 (Actual)
Study Completion Date
August 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Gardner GOALS is a 6 month program for treatment of childhood obesity that consists of twice monthly telehealth meetings with a health educator. Potential participants enter the study using a randomly ordered list of eligible patients based on BMI, age and number of clinic visits in 2020.
Detailed Description
The Gardner GOALS curriculum focuses on healthy eating and activity. The study participants are kids 6 to 14 years old with BMI ≥95th percentile who are patients at the Gardner Packard Children's Health Center, a federally qualified health center. Lessons contain educational materials and behavioral change strategies to promote healthy eating and physical activity and reduce screen time. Patients are encouraged to continue routine clinic visits with their primary care physicians during the course of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gardner GOALS
Arm Type
Experimental
Arm Description
Healthy lifestyle intervention by telehealth plus regular clinic visits
Arm Title
Control
Arm Type
No Intervention
Arm Description
Regular clinic visits
Intervention Type
Behavioral
Intervention Name(s)
Gardner GOALS
Intervention Description
12 lesson curriculum focusing on healthy eating, increased physical activity and decreased screen time
Primary Outcome Measure Information:
Title
Body mass index
Description
Change in trajectory of body mass index from the year prior to the intervention compared to the year after starting the intervention
Time Frame
Baseline, year 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: BMI ≥ 95th percentile Two clinic visits in 2020 Exclusion Criteria: Signs of an eating disorder Moved out of town and not planning to return to Gardner Packard Children's Health Center
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Shepard, MD
Organizational Affiliation
Stanford University
Official's Role
Study Director
Facility Information:
Facility Name
Gardner Packard Children's Health Center
City
Atherton
State/Province
California
ZIP/Postal Code
94027
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Gardner Packard Healthy Lifestyles Program

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