NCT01409889

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2011

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

January 18, 2016

Status Verified

January 1, 2016

Enrollment Period

1.3 years

First QC Date

August 2, 2011

Last Update Submit

January 15, 2016

Conditions

Pre DiabetesDiabetes

Outcome Measures

Primary Outcomes (1)

  • Participant Weight

    7% reduction in participant weight

    22 weeks

Secondary Outcomes (1)

  • Minutes of Physical Activity

    22 weeks

Study Arms (2)

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

Diabetes Prevention ProgramBEHAVIORAL
Also known as: DPP
Diabetes Prevetion Program
Healthy Living ProgramBEHAVIORAL
Also known as: HLP
Healthy Living Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • at least 18 years old
  • diagnosed with pre-diabetes

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Anthony Jordan Health Center

Rochester, New York, 14605, United States

Location

Rochester General Medical Associates

Rochester, New York, 14605, United States

Location

Unity Health System

Rochester, New York, 14606, United States

Location

Westside Health Services

Rochester, New York, 14611, United States

Location

MeSH Terms

Conditions

Glucose IntoleranceDiabetes Mellitus

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 2, 2011

First Posted

August 4, 2011

Study Start

May 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

January 18, 2016

Record last verified: 2016-01

Locations

US(4)