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SPARK a Healthy and Fit Lifestyle

This study is currently recruiting participants.
Verified March 2012 by The Miriam Hospital
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT01578512
First received: April 12, 2012
Last updated: April 16, 2012
Last verified: March 2012
History of Changes
  Purpose

The purpose of this study is to determine the best format for delivering a brief behavioral weight loss intervention to young adults 18-25 years of age.


Condition Intervention
Obesity
 Behavioral: Face-to-Face
Behavioral: Web-based
Behavioral: Single session

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: SPARK a Healthy and Fit Lifestyle

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:
  • Weight [ Time Frame: 2 months (post-treatment) ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: February 2012
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Face-to-Face
8 sessions of weekly group behavioral weight loss treatment
 Behavioral: Face-to-Face
Face-to-Face behavioral weight loss
Experimental: Web-based
Participants receive one group face-to-face session followed by 7 web-based lessons, reporting of key behaviors, and feedback on progress.
 Behavioral: Web-based
Web-based behavioral weight loss
Active Comparator: Single Session
Single session behavioral weight loss
 Behavioral: Single session
The core of behavioral weight loss, including calorie and activity prescriptions, are delivered in a single group treatment session.

  Eligibility

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-25 years old
  • body mass index 25-45
  • willing to be randomly assigned to any of the 3 arms
  • available during the time frame of the study
  • willing to complete assessment visits at 0, 2, 4 and 6 months

Exclusion Criteria:

  • Age or BMI outside of eligible range
  • Medical condition that would interfere with weight loss or make unsupervised physical activity unsafe
  • Pregnant or nursing within 6 months
  • recent weight loss >10% of body weight
  • History of eating disorder
  • Substance abuse or dependence
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01578512

Contacts
Contact: Jessica LaRose, PhD 401-793-8283 jessica_gokee_larose@brown.edu

Locations
United States, Rhode Island
Weight Control and Diabetes Research Center, the Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Jessica LaRose, PhD     401-793-8283        
Principal Investigator: Jessica G LaRose, PhD            
Sub-Investigator: Rena R Wing, PhD            
Sponsors and Collaborators
The Miriam Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  More Information

Additional Information:
recruitment website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: The Miriam Hospital
ClinicalTrials.gov Identifier: NCT01578512     History of Changes
Other Study ID Numbers: DK083440
Study First Received: April 12, 2012
Last Updated: April 16, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

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

ClinicalTrials.gov processed this record on May 19, 2013