Impact of Group Size in Weight Loss Interventions | NCT01165151

Studies
Impact of Group Size in Weight Loss Interventions

NCT01165151

Sponsor

Florida State University

Status

Completed

Last Update Posted

Mar 6, 2015Estimated

Enrollment

70Estimated

Phase

Phase 4

Conditions

Obesity
Weight Loss

Interventions

behavioral weight loss program

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 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Jul 16, 2010

First Submission Date that Met QC Criteria

Jul 16, 2010

First Posted Date

Jul 19, 2010Estimated

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

Mar 4, 2015

Last Update Posted Date

Mar 6, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 present study will assess whether the size of treatment groups (groups of 10 vs. 30 participants) affects short- and long-term weight loss. It is hypothesized that participants assigned to a small group will exhibit similar short-term and long-term weight losses (i.e., weight loss at months 6 and 12) as compared to those assigned to a large group.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Small group	Experimental	10-member groups	Behavioral: behavioral weight loss program
Large group	Active Comparator	30-member groups	Behavioral: behavioral weight loss program

Interventions

Name	Type	Description	Arm Group Labels	Other Names
behavioral weight loss program	Behavioral	weekly, group-based lifestyle weight loss program	Large group Small group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in weight from baseline to month 12		12 months

Secondary Outcomes

Measure	Description	Time Frame
adherence to treatment protocol	number and proportion of treatment sessions attended	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults (at least 21 years-old)
Health insurance coverage with Capital Health Plan (CHP)
Body mass index BMI between 30-45 kg/m2

Exclusion Criteria:

BMI is less than 30 kg/m2 or greater than 45 kg/m2
Weight loss > 10 pounds in past 6 months
Acute or chronic illnesses for which weight loss is contraindicated
Unwilling or unable to give informed consent
Unwilling to accept random assignment
Unwilling or unable to travel to CHP clinic for assessments and groups
Likely to relocate out of the area in the next 12 months

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Florida State University		Tallahassee	Florida	32306	United States

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D015431	Weight Loss

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided