SPARK a Healthy and Fit Lifestyle | NCT01578512

Studies
SPARK a Healthy and Fit Lifestyle

NCT01578512

Sponsor

The Miriam Hospital

Status

Unknown status

Last Update Posted

Apr 17, 2012Estimated

Enrollment

45Estimated

Phase

Not Applicable

Conditions

Obesity

Interventions

Face-to-Face
Web-based
Single session

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Aug 2012Estimated

Completion Date

Nov 2012Estimated

First Submitted Date

Apr 12, 2012

First Submission Date that Met QC Criteria

Apr 16, 2012

First Posted Date

Apr 17, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2012

Last Update Posted Date

Apr 17, 2012Estimated

Name	Class
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Face-to-Face	Experimental	8 sessions of weekly group behavioral weight loss treatment	Behavioral: Face-to-Face
Web-based	Experimental	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
Single Session	Active Comparator	Single session behavioral weight loss	Behavioral: Single session

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Face-to-Face	Behavioral	Face-to-Face behavioral weight loss	Face-to-Face

Measure	Description	Time Frame
Weight		2 months (post-treatment)

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

25 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jessica LaRose, PhD	Contact	401-793-8283		jessica_gokee_larose@brown.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Weight Control and Diabetes Research Center, the Miriam Hospital	Recruiting	Providence	Rhode Island	02903	United States

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided