NCT02555631

Brief Summary

The purpose of this two-year proposal is to:

  1. 1.develop and
  2. 2.complete a pilot test of an adaptation of the evidence-based National Diabetes Prevention Program (NDPP) tailored to engage men with prediabetes in disadvantaged communities in New York City.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

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

September 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 21, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

June 28, 2018

Completed
Last Updated

June 28, 2018

Status Verified

June 1, 2018

Enrollment Period

1 year

First QC Date

September 17, 2015

Results QC Date

January 11, 2018

Last Update Submit

June 27, 2018

Conditions

Keywords

type 2 diabetespreventionmen

Outcome Measures

Primary Outcomes (1)

  • Change in Weight in Pounds

    the goal is to lose 5-7% of baseline body weight for pre-diabetic men

    Baseline, 16 weeks

Secondary Outcomes (3)

  • Number of Men Enrolled During 8 Weeks of Recruitment

    8 weeks

  • Number of Sessions Attended

    16 weeks

  • Number of Participants That Participated in Each Session

    16 weeks

Study Arms (1)

lifestyle intervention

EXPERIMENTAL

In this pilot study, each subject will receive the lifestyle intervention of the diabetes prevention program, a modified program for men from disadvantaged neighborhoods--a 16 weekly sessions of 1 hour each session

Behavioral: lifestyle

Interventions

lifestyleBEHAVIORAL

In this pilot study, each subject will receive the lifestyle intervention of the diabetes prevention program, a modified program for men from disadvantaged neighborhoods--a 16 weekly sessions of 1 hour each session

lifestyle intervention

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • pre-diabetes by ADA risk test or an A1c in past year in prediabetes range
  • BMI 24 or above (22 for Asians)
  • male
  • lives, works or spend much time in the disadvantaged neighborhood of the park site

You may not qualify if:

  • cannot read or write in English or Spanish
  • has diagnosed diabetes
  • obvious mental disability so as to preclude health behavior changes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Multiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesMultiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

Title
Dr. Elizabeth Walker
Organization
Albert Einstein College of Medicine

Study Officials

  • Elizabeth A. Walker, PhD, RN

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

September 17, 2015

First Posted

September 21, 2015

Study Start

September 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

June 28, 2018

Results First Posted

June 28, 2018

Record last verified: 2018-06

Locations