Gardner Packard Healthy Lifestyles Program | NCT05107648

Studies
Gardner Packard Healthy Lifestyles Program

NCT05107648

Sponsor

Stanford University

Status

Completed

Last Update Posted

Sep 23, 2022Actual

Enrollment

42Actual

Phase

Not Applicable

Conditions

Childhood Obesity

Interventions

Gardner GOALS

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 6, 2021Actual

Primary Completion Date

Aug 28, 2022Actual

Completion Date

Aug 28, 2022Actual

First Submitted Date

Oct 20, 2021

First Submission Date that Met QC Criteria

Oct 20, 2021

First Posted Date

Nov 4, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2022

Last Update Posted Date

Sep 23, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Elizabeth Shepard, Clinical Associate Professor of Pediatrics, Stanford UniversityPrincipal Investigator

Lead Sponsor

Stanford UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gardner GOALS	Experimental	Healthy lifestyle intervention by telehealth plus regular clinic visits	Behavioral: Gardner GOALS
Control	No Intervention	Regular clinic visits

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gardner GOALS	Behavioral	12 lesson curriculum focusing on healthy eating, increased physical activity and decreased screen time	Gardner GOALS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

14 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elizabeth Shepard, MD	Stanford University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gardner Packard Children's Health Center		Atherton	California	94027	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D063766	Pediatric Obesity

Ancestor Terms

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided