NCT02771951

Brief Summary

This randomized controlled trial tests the efficacy of a culturally and linguistically appropriate, evidence-based intervention to slow weight gain or promote weight loss among overweight 6-9 year old Mexican-American children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
297

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2010

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2016

Completed
Last Updated

May 13, 2016

Status Verified

May 1, 2016

Enrollment Period

5.9 years

First QC Date

May 9, 2016

Last Update Submit

May 12, 2016

Conditions

OverweightPediatric Obesity

Keywords

ChildhoodObesity

Outcome Measures

Primary Outcomes (1)

  • Body Mass Index

    1 year

Study Arms (2)

Special Intervention

EXPERIMENTAL

Study participants randomized to receive Special Intervention receive a series of 7 group classes taught by trained clinic health educators; a series of phone calls; clinical visits with a mid-level provider; and a series of 6 booster group classes over 1 year.

Behavioral: "Lights of Change"

Usual Care

PLACEBO COMPARATOR

Study participants randomized to receive Usual Care receive up to 2 visits with a usual care health educator over 1 year.

Behavioral: Usual Care

Interventions

"Lights of Change"BEHAVIORAL
Special Intervention
Usual CareBEHAVIORAL
Usual Care

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Self-identify as Latino
  • Have made a clinic visit within past 24 months prior to enrollment in study
  • Have a BMI % for age/gender between 75 - 99.9th
  • Plan on living in target area for following 18 months
  • Have transportation to participating clinic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Behavioral and Community Health at San Diego State University

San Diego, California, 92123, United States

Location

MeSH Terms

Conditions

OverweightPediatric ObesityObesity

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Professor of Public Health; and Adjunct Professor of Family and Precentive Medicine, UCSD

Study Record Dates

First Submitted

May 9, 2016

First Posted

May 13, 2016

Study Start

April 1, 2010

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

May 13, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)