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SPARK a Healthy and Fit Lifestyle (SPARK)

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ClinicalTrials.gov Identifier: NCT01578512
Recruitment Status : Unknown
Verified March 2012 by The Miriam Hospital.
Recruitment status was:  Recruiting
First Posted : April 17, 2012
Last Update Posted : April 17, 2012
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
The Miriam Hospital

Brief Summary:
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 or disease Intervention/treatment
Obesity Behavioral: Face-to-Face Behavioral: Web-based Behavioral: Single session

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: SPARK a Healthy and Fit Lifestyle
Study Start Date : February 2012
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : November 2012

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Weight [ Time Frame: 2 months (post-treatment) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01578512

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

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)

Responsible Party: The Miriam Hospital
ClinicalTrials.gov Identifier: NCT01578512     History of Changes
Other Study ID Numbers: DK083440
First Posted: April 17, 2012    Key Record Dates
Last Update Posted: April 17, 2012
Last Verified: March 2012