NCT01156402

Brief Summary

The purpose of this study is to evaluate the efficacy of a culturally-appropriate childhood obesity intervention with Hispanic families. The program aims at preventing childhood obesity by targeting parents to address nutrition, physical activity, and sedentary behaviors in their children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
319

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2010

Longer than P75 for not_applicable

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

May 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 14, 2010

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 2, 2010

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 6, 2016

Status Verified

May 1, 2016

Enrollment Period

3.5 years

First QC Date

June 14, 2010

Last Update Submit

May 5, 2016

Conditions

Childhood Obesity

Keywords

ObesityPediatric Obesity

Outcome Measures

Primary Outcomes (1)

  • Body Mass Index (BMI)-for-age percentile

    one year

Secondary Outcomes (4)

  • Child eating behaviors

    One year

  • Child physical activity (accelerometers)

    One year

  • Parenting strategies

    One year

  • parent physical activity

    one year

Study Arms (2)

Active Intervention: Obesity Prevention

EXPERIMENTAL
Behavioral: Healthy Families-Childhood Obesity Prevention and Oral Health

Alternative Intervention/control: Oral Health

EXPERIMENTAL
Behavioral: Healthy Families-Childhood Obesity Prevention and Oral Health

Interventions

Healthy Families-Childhood Obesity Prevention and Oral HealthBEHAVIORAL

The active intervention was adapted from the We Can! parent intervention to be culturally-appropriate for Hispanic families of children ages 5-7. The tailored intervention is based on Social Cognitive Theory and Behavioral Choice Theory to provide parents and children with cognitive and behavioral skills to enable change in the target behaviors, and to encourage them to practice using these skills to strengthen their perceived competence in using these behaviors effectively.

Active Intervention: Obesity PreventionAlternative Intervention/control: Oral Health

Eligibility Criteria

Age5 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children:
  • year-old female or male of Hispanic origin (identified by parent)
  • resident of Davidson County or adjacent counties
  • ≥25th percentile of age- and sex-specific BMI (CDC growth charts) or one parent/caregiver with BMI ≥ 25 kg/m2
  • More than one child may enroll per family
  • Parents:
  • Hispanic origin (self-identified)
  • Spanish speaker
  • adult age 18 or older
  • parent of at least one eligible child
  • Only one parent per family may enroll as a study participant and respond to questionnaires

You may not qualify if:

  • Children:
  • BMI ≥ 35 kg/m2
  • Medical conditions affecting growth
  • Conditions limiting participation in the interventions or measurements
  • Taking medications affecting growth
  • No consent or inability to understand informed consent
  • Incomplete or missed baseline assessments
  • Plan to move from geographic area within the next 12 months.
  • Parents:

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Vanderbilt University

Nashville, Tennessee, 37203, United States

Location

Meharry Medical College

Nashville, Tennessee, 37208, United States

Location

Related Publications (1)

  • Zoorob R, Buchowski MS, Beech BM, Canedo JR, Chandrasekhar R, Akohoue S, Hull PC. Healthy families study: design of a childhood obesity prevention trial for Hispanic families. Contemp Clin Trials. 2013 Jul;35(2):108-21. doi: 10.1016/j.cct.2013.04.005. Epub 2013 Apr 26.

    PMID: 23624172BACKGROUND

MeSH Terms

Conditions

Pediatric ObesityObesity

Interventions

Oral Health

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

HealthPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2010

First Posted

July 2, 2010

Study Start

May 1, 2010

Primary Completion

November 1, 2013

Study Completion

May 1, 2016

Last Updated

May 6, 2016

Record last verified: 2016-05

Locations

US(2)