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The Role of Parents in Adolescent Weight Loss

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by The Miriam Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:
The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT01139411
First received: June 7, 2010
Last updated: July 19, 2011
Last verified: June 2010
History of Changes
  Purpose

The purpose of the study is to determine whether a novel model of including parents in adolescent weight control results in greater decrease in adolescent z-BMI compared to an intervention with minimal parent involvement.


Condition Intervention Phase
Adolescent Obesity
 Behavioral: Behavioral Weight Control with Enhanced Parent Involvement
Behavioral: Behavioral Weight Control with Minimal Parent Involvement
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Parental Involvement as a Strategy to Enhance Adolescent Weight Control

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:
  • Body Mass Index [ Time Frame: Baseline and at completion of 16 week intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: August 2009
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Behavioral Weight Control with Enhanced Parent Involvement Behavioral: Behavioral Weight Control with Enhanced Parent Involvement
Placebo Comparator: Behavioral Weight Control with Minimal Parent Involvement Behavioral: Behavioral Weight Control with Minimal Parent Involvement

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Between 30 and 90% overweight
  • Parent or guardian willing to participate

Exclusion Criteria:

  • Major psychiatric disorder
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01139411

Locations
United States, Rhode Island
The Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact: Elissa Jelalian, PhD     401-793-8993     EJelalian@lifespan.org    
Principal Investigator: Elissa Jelalian, PhD            
Sponsors and Collaborators
The Miriam Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  More Information

No publications provided

Responsible Party: Elissa Jelalian, PhD, Principal Investigator, The Miriam Hospital
ClinicalTrials.gov Identifier: NCT01139411     History of Changes
Other Study ID Numbers: GRANT00538804, R03HD060137
Study First Received: June 7, 2010
Last Updated: July 19, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013