Gardner Packard Healthy Lifestyles Program

Childhood Obesity Clinical Trial

Official title:

Gardner GOALS for Treatment of Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05107648
• Other study ID #: 53309
• Status: Completed
• Phase: N/A
• Start date: May 6, 2021
• Est. completion date: August 28, 2022

Study information

• Verified date: September 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 28, 2022
• Est. primary completion date: August 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Gardner GOALS
12 lesson curriculum focusing on healthy eating, increased physical activity and decreased screen time

Locations

Country	Name	City	State
United States	Gardner Packard Children's Health Center	Atherton	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline, year 1