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SPARK a Healthy and Fit Lifestyle

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by The Miriam Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
  More Information

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

ClinicalTrials.gov processed this record on November 27, 2014