NCT05107648

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 6, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 4, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2022

Completed
Last Updated

September 23, 2022

Status Verified

September 1, 2022

Enrollment Period

1.3 years

First QC Date

October 20, 2021

Last Update Submit

September 22, 2022

Conditions

Childhood Obesity

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Gardner GOALS

EXPERIMENTAL

Healthy lifestyle intervention by telehealth plus regular clinic visits

Behavioral: Gardner GOALS

Control

NO INTERVENTION

Regular clinic visits

Interventions

Gardner GOALSBEHAVIORAL

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

Gardner GOALS

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gardner Packard Children's Health Center

Atherton, California, 94027, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Elizabeth Shepard, MD

    Stanford University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor of Pediatrics

Study Record Dates

First Submitted

October 20, 2021

First Posted

November 4, 2021

Study Start

May 6, 2021

Primary Completion

August 28, 2022

Study Completion

August 28, 2022

Last Updated

September 23, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)