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NCT05107648 Clinical Trial

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
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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