SPARK a Healthy and Fit Lifestyle (SPARK)

April 16, 2012 updated by: The Miriam Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Weight Control and Diabetes Research Center, The Miriam Hospital
        • Contact:
          • Jessica LaRose, PhD
          • Phone Number: 401-793-8283
        • Principal Investigator:
          • Jessica G LaRose, PhD
        • Sub-Investigator:
          • Rena R Wing, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight
Time Frame: 2 months (post-treatment)
2 months (post-treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Miriam Hospital

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Anticipated)

August 1, 2012

Study Completion (Anticipated)

November 1, 2012

Study Registration Dates

First Submitted

April 12, 2012

First Submitted That Met QC Criteria

April 16, 2012

First Posted (Estimate)

April 17, 2012

Study Record Updates

Last Update Posted (Estimate)

April 17, 2012

Last Update Submitted That Met QC Criteria

April 16, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • DK083440

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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