Gardner Packard Healthy Lifestyles Program

NCT ID: NCT05107648

Last Updated: 2022-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-06

Study Completion Date

2022-08-28

Brief Summary

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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

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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.

Conditions

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Childhood Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Gardner GOALS

Healthy lifestyle intervention by telehealth plus regular clinic visits

Group Type EXPERIMENTAL

Gardner GOALS

Intervention Type BEHAVIORAL

12 lesson curriculum focusing on healthy eating, increased physical activity and decreased screen time

Control

Regular clinic visits

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Gardner GOALS

12 lesson curriculum focusing on healthy eating, increased physical activity and decreased screen time

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth Shepard

Clinical Associate Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elizabeth Shepard, MD

Role: STUDY_DIRECTOR

Stanford University

Locations

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Gardner Packard Children's Health Center

Atherton, California, United States

Site Status

Countries

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United States

Other Identifiers

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53309

Identifier Type: -

Identifier Source: org_study_id

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