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临床试验/NCT04132739
NCT04132739终止不适用

Piloting Diet and Exercise Interventions in Older Hispanics With Diabetes

Florida International University8 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
39
试验地点
8
主要终点
Changes in gait

研究概览

简要总结

Type 2 diabetes affects 9.3% of the U.S. population and health disparities are evident. Compared to non-Hispanic Whites, twice as many Hispanics have type 2 diabetes. The estimated cost of diabetes was $327 billion in 2017. Older adults with type 2 diabetes often have increased risk of falls. Type 2 diabetes standard of care includes one annual self-management session, which rarely include assessments of mobility impairments and falls, and diabetes education programs are less likely to be offered and more likely to be discontinued in economically disadvantaged communities. Consequently, diabetes-related hospitalizations have doubled in the past 20 years. The objective of this study is to pilot test nutrition and exercise interventions to improve diabetes management (e.g. glycemic control and diet quality) and physical function, reduce falls and related healthcare use by disadvantaged older Hispanics with type 2 diabetes. The interventions will be tested separately and in combination to assess their individual and combined effects. We will recruit 60 older Hispanics with type 2 diabetes from 4 senior centers. The exercise intervention was adapted from the evidence-based Otago Exercise Program for falls prevention in older adults. The nutrition intervention aims to improve glycemic control and diet quality. We will cluster-randomize the participants into the following arms (n=15/arm) based on the congregate meal sites they attend: 1) Control (no intervention); 2) Exercise only; 3) Nutrition only, and 4) Exercise+Nutrition. The project will last 15 months; the duration of the interventions will be 6 months, and assessments will be completed at baseline, 3, 6, 9, and 12 months. The impact of the interventions will be assessed based on hemoglobin A1C levels (glycemic control), diet quality (Healthy Eating Index), blood pressure, physical function (balance, gait, strength, body composition, and fear of falls), and self-reported falls and healthcare use.

详细描述

The pilot study will show the potential individual and combined effects of nutrition and exercise programs for disadvantaged older Hispanics with type 2 diabetes. The benefits to the participants include: 1) enhanced type 2 diabetes management; 2) improved diet quality and nutritional status; 3) improved physical function; 4) reduced rates of falls; and, 5) reduced rates of diabetes and fall-related emergency room visits and hospitalizations. The expected product is an effective type 2 diabetes management and falls prevention program for underserved Hispanic older adults with type 2 diabetes. If effective, the program may be expanded to additional congregate meal sites and communities serving older Hispanics.

The proposed study is a pilot cluster-randomized pilot trial for socioeconomically disadvantaged older Hispanics with type 2 diabetes. The participants will be cluster-randomized to one of the following four groups (n=10/group) based on the facilities they go for congregate meals: 1) Control (no intervention); 2) Exercise program only; 3) Nutrition program only; 4) Exercise and nutrition program. The interventions groups (2-4) will also receive basic diabetes education. The interventions will be randomized to sites to avoid cross-contamination. The interventions will last 6 months and assessments will be completed at baseline, 3, 6, 9, and 12 months.

The proposed pilot study is innovative because there are no exercise and nutrition programs for older Hispanics with type 2 diabetes; because it targets understudied socioeconomically disadvantaged older Hispanics with type 2 diabetes; it tests the separate and combined effects of nutrition and exercise interventions, and because we will assesses the outcomes as well as the mechanisms of falls reduction and improved type 2 diabetes management based on hemoglobin A1C levels, Healthy Eating Index scores, blood pressure, balance, gait, strength, and health care use.

We will assess the effects of the programs when delivered in isolation and in combination in relation to a control group. The client-centered programs will be delivered in the congregate meal sites and the participants will track their exercise, diet and medication adherence behaviors. We will evaluate the effects of the programs in physical function (gait, strength and balance), diet quality, nutritional status, falls rates and associated emergency room visits and hospitalizations. Glycemic control, physical function and falls in older people with type 2 diabetes can be addressed with exercise and adequate nutrition, but the uptake and implementation of these evidence-based interventions in the community is limited, especially among socioeconomically disadvantaged minority groups.

The interventions will be tailored culturally and to needs of older Hispanics with type 2 diabetes by respecting the participants' language choice, physical abilities and impairments, and food preferences. The nutritional intervention will consider the participants eating habits, preferences, food availability and costs, and the participants own goals. The exercise sessions will consider the participants limitations and health conditions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 65 years
  • Type 2 diabetes
  • Hispanic ethnicity
  • >3/5 points in the Mini Cog test
  • Score >17 on the Mini Nutritional Assessment

排除标准

  • Not willing or not able to exercise due to medical issues or physical limitations
  • Malnutrition: Score <17 on the Mini Nutritional Assessment
  • On dialysis
  • Liver disease,
  • Other physical/psychological condition preventing participation

结局指标

主要结局

Changes in gait

时间窗: Baseline, 3, 6, 9 and 12 months

Gait will be assessed during preferred speed and fast walking conditions using a GAITRite® system (SN: Q209, CIR Systems Inc).

Changes in balance

时间窗: Baseline, 3, 6, 9 and 12 months

Balance will be assessed based on postural sway frequency, velocity and area during bipedal and single-leg stance for 30 seconds with eyes open and closed on a force plate.

Changes in hemoglobin A1C.

时间窗: Baseline, 3, 6, 9 and 12 months

Changes in hemoglobin A1C.

Changes in diet quality based on the Healthy Eating Index scores

时间窗: Baseline, 6 and 12 months

The scores range from 0 to 100. A score of 100 means that the foods align with the Dietary Guidelines for Americans.

Changes in strength

时间窗: Baseline, 3, 6, 9 and 12 months

Grip strength will be assessed using a Jamar dynamometer allowing adaptable grip, and lower limbs' functional strength will be assessed based on the number of chair-stands completed in 30 seconds.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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