Impact of a Childhood Obesity Intervention for African Am... | NCT02044731

Studies
Impact of a Childhood Obesity Intervention for African American Families

NCT02044731

Sponsor

University of California, Berkeley

Status

Completed

Last Update Posted

Dec 9, 2014Estimated

Enrollment

19Actual

Phase

Not Applicable

Conditions

Obesity
Overweight

Interventions

Active and Healthy Families

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

ID	Type	Description	Link
033728B	Other Grant/Funding Number	Safeway Foundation

Status Module

Record Verification Date

Dec 2014

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

Jan 2014

Primary Completion Date

Jun 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Jan 22, 2014

First Submission Date that Met QC Criteria

Jan 22, 2014

First Posted Date

Jan 24, 2014Estimated

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

Dec 8, 2014

Last Update Posted Date

Dec 9, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of this study is to evaluate the impact on body mass index (BMI) of a 5-session childhood obesity intervention for African American families among children aged 5-12 years. We hypothesize that children participating in the program will experience a reduction in BMI.

Detailed Description

Not provided

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

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Family group sessions	Experimental	Active and Healthy Families	Behavioral: Active and Healthy Families

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Active and Healthy Families	Behavioral	A pediatric overweight/obesity intervention delivered through five bi-weekly family-based group sessions.	Family group sessions

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Body mass index (BMI)	Change in BMI will be calculated from measured height and weight	Baseline and at week 10

Secondary Outcomes

Measure	Description	Time Frame
Blood pressure	Change will be calculated based on measured blood pressure	Baseline and at week 10

Other Outcomes

Measure	Description	Time Frame
Parent weight	Change will be calculated based on measured weight of parent	Baseline and at week 10
Parent reported behaviors	Survey responses on parenting and child's dietary, physical activity, and screen time behaviors.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI greater than or equal to the 85th percentile for age and sex
Attends an elementary school in the Pittsburg Unified School District in California
Parent of child meeting above criteria

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kristine A Madsen, MD	University of California, Berkeley	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Parkside Elementary School		Pittsburg	California	94565	United States

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D050177	Overweight

Ancestor Terms

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided