Translating the Diabetes Prevention Program to Engage Men From Disadvantaged Areas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Change in Weight in Pounds
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •pre-diabetes by ADA risk test or an A1c in past year in prediabetes range
- •BMI 24 or above (22 for Asians)
- •lives, works or spend much time in the disadvantaged neighborhood of the park site
排除标准
- •cannot read or write in English or Spanish
- •has diagnosed diabetes
- •obvious mental disability so as to preclude health behavior changes
研究组 & 干预措施
lifestyle intervention
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
干预措施: lifestyle (Behavioral)
结局指标
主要结局
Change in Weight in Pounds
时间窗: Baseline, 16 weeks
the goal is to lose 5-7% of baseline body weight for pre-diabetic men
次要结局
- Number of Participants That Participated in Each Session(16 weeks)
- Number of Men Enrolled During 8 Weeks of Recruitment(8 weeks)
- Number of Sessions Attended(16 weeks)
研究者
Elizabeth Walker
Professor of Medicine
Albert Einstein College of Medicine