Comparing Diabetes Prevention Programs | NCT01409889

Studies
Comparing Diabetes Prevention Programs

NCT01409889

Sponsor

University of Rochester

Status

Completed

Last Update Posted

Jan 18, 2016Estimated

Enrollment

92Actual

Phase

Not Applicable

Conditions

Pre Diabetes
Diabetes

Interventions

Diabetes Prevention Program
Healthy Living 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

Jan 2016

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

May 2011

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Aug 2, 2011

First Submission Date that Met QC Criteria

Aug 2, 2011

First Posted Date

Aug 4, 2011Estimated

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

Jan 15, 2016

Last Update Posted Date

Jan 18, 2016Estimated

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 compare the effectiveness and costs of two programs,the Diabetes Prevention Program and the community-developed Healthy Living Program, delivered in an primary care practice.

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

92Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diabetes Prevetion Program	Active Comparator	Individuals in this group will receive the Diabetes Prevention Program	Behavioral: Diabetes Prevention Program
Healthy Living Program	Active Comparator	Individuals in this group will receive the Healthy Living Program	Behavioral: Healthy Living Program

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diabetes Prevention Program	Behavioral		Diabetes Prevetion Program	DPP
Healthy Living Program

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Participant Weight	7% reduction in participant weight	22 weeks

Secondary Outcomes

Measure	Description	Time Frame
Minutes of Physical Activity	Increase physical activity to 150 minutes per week.	22 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

at least 18 years old
diagnosed with pre-diabetes

Exclusion Criteria:

diagnosed with diabetes
pregnant or nursing
unable to walk 2-3 blocks in 10 minutes
unable to read and speak English

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 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
Anthony Jordan Health Center		Rochester	New York	14605	United States
Rochester General Medical Associates

Condition Browse Module

MeSH Terms

ID	Term
D018149	Glucose Intolerance
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D006943	Hyperglycemia
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided