PowerUp for Health: A Diabetes Prevention Program for Men

Type 2 Diabetes Clinical Trial

Official title:

Translating the Diabetes Prevention Program to Engage Men From Disadvantaged Areas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02555631
• Other study ID #: 2014-3604
• Secondary ID: R18DK102080
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: September 2016

Study information

• Verified date: June 2018
• Source: Albert Einstein College of Medicine, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this two-year proposal is to:

1. develop and

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.

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.

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♂.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Men
• Type 2 Diabetes

Intervention

Behavioral:
• lifestyle
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

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine	Bronx	New York

Sponsors (4)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine, Inc.	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), The New York Academy of Medicine, University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Weight in Pounds	the goal is to lose 5-7% of baseline body weight for pre-diabetic men	Baseline, 16 weeks
Secondary	Number of Men Enrolled During 8 Weeks of Recruitment	measured by numbers of men and the timeframe in which the recruitment takes place;	8 weeks
Secondary	Number of Sessions Attended	with a measured goal of at least attendance observed and recorded at 9/16 sessions on average	16 weeks
Secondary	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	16 weeks