NCT02373670

Brief Summary

A feasibility study randomizing participants (parents of children age 2-5 years old) to receive either education or a parent mentor with the aim of improving health behaviors and improving their body mass index z-score.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jan 2015

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 27, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 14, 2016

Status Verified

March 1, 2016

Enrollment Period

1 year

First QC Date

February 20, 2015

Last Update Submit

March 11, 2016

Conditions

Obesity

Keywords

Positive deviancePeer mentors

Outcome Measures

Primary Outcomes (1)

  • Body mass index z-score

    6 months

Study Arms (2)

Parent Mentor

EXPERIMENTAL

Parent mentors using positive deviance findings to promote healthy behaviors

Behavioral: Promotion of positive deviance behaviors

Education

ACTIVE COMPARATOR

Community health workers providing health education to promote healthy behaviors

Behavioral: Promotion of healthy behaviors

Interventions

Promotion of positive deviance behaviorsBEHAVIORAL

Using locally derived positive deviance findings to inform a behavioral intervention

Parent Mentor
Promotion of healthy behaviorsBEHAVIORAL

Using standardized healthy behavior education (EatPlayGrow curriculum from NHLBI)

Education

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • BMI z-score \>2

You may not qualify if:

  • Medical conditions or receiving medications affecting weight

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (2)

  • Hollister EB, Foster BA, Dahdouli M, Ramirez J, Lai Z. Characterization of the Stool Microbiome in Hispanic Preschool Children by Weight Status and Time. Child Obes. 2018 Feb/Mar;14(2):122-130. doi: 10.1089/chi.2017.0122. Epub 2017 Oct 13.

    PMID: 29028448DERIVED

  • Foster BA, Aquino CA, Gil M, Gelfond JA, Hale DE. A Pilot Study of Parent Mentors for Early Childhood Obesity. J Obes. 2016;2016:2609504. doi: 10.1155/2016/2609504. Epub 2016 Jun 9.

    PMID: 27379182DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

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

February 20, 2015

First Posted

February 27, 2015

Study Start

January 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

March 14, 2016

Record last verified: 2016-03

Locations

US(1)