NCT02044731

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable obesity

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 24, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

December 9, 2014

Status Verified

December 1, 2014

Enrollment Period

5 months

First QC Date

January 22, 2014

Last Update Submit

December 8, 2014

Conditions

ObesityOverweight

Keywords

SchoolsPediatricsObesityOverweightIntervention StudiesAfrican AmericansFamilyBody mass index

Outcome Measures

Primary Outcomes (1)

  • Body mass index (BMI)

    Change in BMI will be calculated from measured height and weight

    Baseline and at week 10

Secondary Outcomes (1)

  • Blood pressure

    Baseline and at week 10

Other Outcomes (3)

  • Parent weight

    Baseline and at week 10

  • Parent reported behaviors

    Baseline and at 10 weeks

  • Parent blood pressure

    Baseline and at week 10

Study Arms (1)

Family group sessions

EXPERIMENTAL

Active and Healthy Families

Behavioral: Active and Healthy Families

Interventions

Active and Healthy FamiliesBEHAVIORAL

A pediatric overweight/obesity intervention delivered through five bi-weekly family-based group sessions.

Family group sessions

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parkside Elementary School

Pittsburg, California, 94565, United States

Location

MeSH Terms

Conditions

ObesityOverweight

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Kristine A Madsen, MD

    University of California, Berkeley

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2014

First Posted

January 24, 2014

Study Start

January 1, 2014

Primary Completion

June 1, 2014

Study Completion

July 1, 2014

Last Updated

December 9, 2014

Record last verified: 2014-12

Locations

US(1)