SPARK a Healthy and Fit Lifestyle

Obesity Clinical Trial

— SPARK  

Official title:

SPARK a Healthy and Fit Lifestyle

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01578512
• Other study ID #: DK083440
• Status: Recruiting
• Phase: N/A
• First received: April 12, 2012
• Last updated: April 16, 2012
• Start date: February 2012
• Est. completion date: November 2012

Study information

• Verified date: March 2012
• Source: The Miriam Hospital
• Contact: Jessica LaRose, PhD
• Phone: 401-793-8283
• Email: jessica_gokee_larose[@]brown.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: November 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 25 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Face-to-Face
Face-to-Face behavioral weight loss
• Web-based
Web-based behavioral weight loss
• Single session
The core of behavioral weight loss, including calorie and activity prescriptions, are delivered in a single group treatment session.

Locations

Country	Name	City	State
United States	Weight Control and Diabetes Research Center, the Miriam Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
The Miriam Hospital	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight		2 months (post-treatment)	No