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PowerUp for Health: A Diabetes Prevention Program for Men

Primary Purpose

Type 2 Diabetes, Men

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
lifestyle
Sponsored by
Albert Einstein College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes focused on measuring type 2 diabetes, prevention, men

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Albert Einstein College of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

lifestyle intervention

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Men Enrolled During 8 Weeks of Recruitment
measured by numbers of men and the timeframe in which the recruitment takes place;
Number of Sessions Attended
with a measured goal of at least attendance observed and recorded at 9/16 sessions on average
Number of Participants That Participated in Each Session
this is measured by direct observation at selected sessions; report by the lifestyle coach; and discussion during focus groups at the end of the 16 weeks

Full Information

First Posted
September 17, 2015
Last Updated
June 27, 2018
Sponsor
Albert Einstein College of Medicine
Collaborators
The New York Academy of Medicine, University of Pittsburgh, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT02555631
Brief Title
PowerUp for Health: A Diabetes Prevention Program for Men
Official Title
Translating the Diabetes Prevention Program to Engage Men From Disadvantaged Areas
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein College of Medicine
Collaborators
The New York Academy of Medicine, University of Pittsburgh, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this two-year proposal is to: develop and 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. The sites for this pilot study are New York City Parks and recreation centers. Study's main outcome is weight loss of 5-7% baseline weight.
Detailed Description
During year one, the multi-disciplinary research team will work closely with the expert and community Advisory Panel and consultants to adapt the standard NDPP curriculum in order to promote increased engagement of men. "Engagement" is defined in this proposal to include recruitment, group participation and retention in the 16-week program. This modified NDPP♂ (i.e., for men) renamed by the advisory panel as "Power Up for Health," will have only NDPP-trained male coaches and male participants, with adaptations to dietary and physical activity messaging and a new behavioral "toolbox" approach developed for men. By month 10 of year one, investigators will begin implementation of the 16-week pilot studies of the NDPP♂ at 6 NYC Parks and Recreation Department (REC) sites in disadvantaged communities in three of the NYC boroughs currently offering the standard NDPP programming. Investigators will utilize an iterative and adaptive process during the pilot phase to modify recruitment and retention strategies, as well as the NDPP curriculum and activities. The exploratory aim, as feasible, is to then compare the adapted NDPP♂ pilot data to the standard NDPP mixed-gender groups' available data on recruitment, participation, weight loss, and retention of men from similar NYC neighborhoods. The goal will be pilot study data from 15-20 male participants at each REC pilot site-a recruitment goal of 120 male participants. Working in collaboration with the investigators' consultants and Advisory Panel of community leaders and academic experts in men's health promotion, as well as study partners at the NYC Department of Parks and Recreation, investigators will conduct focused outreach to the target populations. The Specific Aims for the Pilot Study are: Aim 1. to collaborate with the expert and community Advisory Panel to complete the adaptation of the NDPP curriculum and the recruitment and retention activities to better engage men with prediabetes from disadvantaged communities of NYC; Aim 2. to assess preliminary indicators of effectiveness of the NDPP♂ with respect to reductions in body weight; Hypothesis 1: Men engaged in the NDPP♂ will have reductions in body weight at 16 weeks at least equivalent to the NDPP goal of 5-7% of their baseline body weight. Aim 3. to examine and describe from pilot data the extent to which recruitment, intervention and retention strategies, tailored for men with prediabetes are associated with improved engagement of the target population; Exploratory Hypothesis 3.1: Recruitment of men to NDPP♂ will occur more rapidly and with less intensive strategies than recruitment of men to the standard NDPP in comparable communities. Exploratory Hypothesis 3.2: Men enrolled in the NDPP♂ will be more engaged in program activities and self-report greater improvements in healthy eating and physical activity compared with men in the standard NDPP. Exploratory Hypothesis 3.3: Men enrolled in the NDPP♂ will have retention rates that are at least equivalent to men in the standard NDPP. All comparison data analyses are exploratory and as data are available. Aim 4. to examine preliminary data to identify demographic, psychosocial, neighborhood, and REC site characteristics associated with differential recruitment, retention and intervention effects in the NDPP♂.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Men
Keywords
type 2 diabetes, prevention, men

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lifestyle intervention
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
lifestyle
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Weight in Pounds
Description
the goal is to lose 5-7% of baseline body weight for pre-diabetic men
Time Frame
Baseline, 16 weeks
Secondary Outcome Measure Information:
Title
Number of Men Enrolled During 8 Weeks of Recruitment
Description
measured by numbers of men and the timeframe in which the recruitment takes place;
Time Frame
8 weeks
Title
Number of Sessions Attended
Description
with a measured goal of at least attendance observed and recorded at 9/16 sessions on average
Time Frame
16 weeks
Title
Number of Participants That Participated in Each Session
Description
this is measured by direct observation at selected sessions; report by the lifestyle coach; and discussion during focus groups at the end of the 16 weeks
Time Frame
16 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: cannot read or write in English or Spanish has diagnosed diabetes obvious mental disability so as to preclude health behavior changes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth A. Walker, PhD, RN
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

Learn more about this trial

PowerUp for Health: A Diabetes Prevention Program for Men

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