NCT02044705

Brief Summary

The purpose of this study is to evaluate the impact of the 10-week Active and Healthy Families (AHF) intervention on body mass index (BMI) in Latino youth aged 5-12 years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

2 active sites

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

September 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
9 months 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
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

April 10, 2015

Status Verified

April 1, 2015

Enrollment Period

8 months

First QC Date

January 22, 2014

Last Update Submit

April 9, 2015

Conditions

OverweightObesity

Keywords

Primary Health CarePediatricsObesityOverweightClinical trialHispanic AmericansFamilyBody mass index

Outcome Measures

Primary Outcomes (1)

  • Changes from baseline in body mass index (BMI)

    Change from baseline are assessed from measured height and weight

    Baseline and at week 10

Secondary Outcomes (4)

  • Change from baseline in blood glucose

    Baseline and week 10

  • Changes from baseline in fasting lipids

    Baseline and week 10

  • Change from baseline in insulin resistance

    Baseline and week 10

  • Change from baseline in blood pressure

    Baseline and week 10

Other Outcomes (1)

  • Change in parent weight

    Baseline and week 10

Study Arms (2)

Family group sessions

EXPERIMENTAL

Active and Healthy Families

Behavioral: Active and Healthy Families

Wait-list control

NO INTERVENTION

Controls may participate in Active and Healthy Families after the study

Interventions

Active and Healthy FamiliesBEHAVIORAL

Pediatric obesity intervention delivered through five bi-weekly Active and Healthy Families family-based group medical appointments (i.e., sessions).

Family group sessions

Eligibility Criteria

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

You may qualify if:

  • Aged 5-12 years
  • Body mass index greater than or equal to the 85th percentile for age and sex
  • Patients seen at Contra Costa County clinics participating in Active and Healthy Families
  • Spanish speaking
  • Parent of participant

You may not qualify if:

  • Previous participation in Active and Healthy Families

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pittsburg Health Center

Pittsburg, California, 94565, United States

Location

West County Health Center

San Pablo, California, 94806, United States

Location

MeSH Terms

Conditions

OverweightObesity

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
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2014

First Posted

January 24, 2014

Study Start

September 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2014

Last Updated

April 10, 2015

Record last verified: 2015-04

Locations

US(2)