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Parent Mentors Using Positive Deviance in Childhood Obesity

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ClinicalTrials.gov Identifier: NCT02373670
Recruitment Status : Completed
First Posted : February 27, 2015
Last Update Posted : March 14, 2016
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Tracking Information
First Submitted Date  ICMJE February 20, 2015
First Posted Date  ICMJE February 27, 2015
Last Update Posted Date March 14, 2016
Study Start Date  ICMJE January 2015
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2015)
Body mass index z-score [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02373670 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Parent Mentors Using Positive Deviance in Childhood Obesity
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • Behavioral: Promotion of positive deviance behaviors
    Using locally derived positive deviance findings to inform a behavioral intervention
  • Behavioral: Promotion of healthy behaviors
    Using standardized healthy behavior education (EatPlayGrow curriculum from NHLBI)
Study Arms  ICMJE
  • Experimental: Parent Mentor
    Parent mentors using positive deviance findings to promote healthy behaviors
    Intervention: Behavioral: Promotion of positive deviance behaviors
  • Active Comparator: Education
    Community health workers providing health education to promote healthy behaviors
    Intervention: Behavioral: Promotion of healthy behaviors
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 20, 2015)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • BMI z-score >2

Exclusion Criteria:

  • Medical conditions or receiving medications affecting weight
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02373670
Other Study ID Numbers  ICMJE 14-470H
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The University of Texas Health Science Center at San Antonio
Study Sponsor  ICMJE The University of Texas Health Science Center at San Antonio
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The University of Texas Health Science Center at San Antonio
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP