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临床试验/NCT04515745
NCT04515745已完成不适用

The Effects of an Intensive Lifestyle Intervention for Type 2 Diabetes on Disability Insurance Applications, Receipt, and Payments

University of Minnesota0 个研究点目标入组 3,091 人开始时间: 2016年12月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3,091
主要终点
Ever received public disability program benefits (Social Security Disability Insurance (SSDI) or disability-related Supplemental Security Income (SSI))

研究概览

简要总结

Starting in 2001, the Look AHEAD study randomized patients with type 2 diabetes to an intensive lifestyle intervention (ILI) focused on weight loss versus a control group receiving diabetes education ("Diabetes Support and Education"). The ILI successfully reduced weight, improved diabetes control, and functional status, among other outcomes. In this study, the investigators will compare participation in federal disability insurance programs between the ILI and the control group during and after the intervention period (2001-2017).

详细描述

Starting in 2001, the Look AHEAD study randomized 5145 patients with type 2 diabetes to an intensive lifestyle intervention (ILI) focused on weight loss versus a control group receiving diabetes education ("Diabetes Support and Education").The Look AHEAD study tested whether participants with type 2 diabetes assigned to an intensive lifestyle intervention (ILI) for weight loss exhibited reductions in cardiovascular morbidity and mortality, relative to a control group receiving usual care and diabetes support and education. During the 12-year intervention period, the ILI led to persistent reductions in weight, waist circumference, and hemoglobin A1c and improvements in physical fitness, among other clinical benefits. After the conclusion of the intervention in 2012, participants were consented to be linked with administrative data. The investigators attempted to link 3188 consenting participants with Social Security Administration databases. Of these, the investigators were able to successfully link 3093 participants. In this study, the investigators will compare participation in federal disability insurance programs including Social Security Disability Insurance (SSDI) and disability-related Supplemental Security Income (SSI) between the linked ILI and the control group during and after the intervention period (2001-2017). The investigators will investigate ILI-versus-control differences in whether participants ever applied or received benefits from SSDI and SSI. The investigators will also investigate ILI-versus-control differences in applications and benefit receipt in each year after randomization, relative to a pre-randomization assessment period. The investigators will use both multivariate regression controlling for baseline participant characteristics and clinic site and also survival analyses that estimate whether the time until SSDI or SSI application or benefit receipt differs between the ILI and control groups.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Look AHEAD participation: met age requirements and other criteria at time of study enrollment which occurred between 2001-2004 (as noted in Look AHEAD Research Group (2013))
  • Consented to administrative data linkages
  • Provided individual identifiers that could be linked with SSA databases
  • Were successfully linked to SSA data

排除标准

  • 未提供

结局指标

主要结局

Ever received public disability program benefits (Social Security Disability Insurance (SSDI) or disability-related Supplemental Security Income (SSI))

时间窗: This measure will capture program participation between randomization (randomization occurred between 2001-2004) through 2017

This is based on Social Security Administration data on SSDI and SSI benefits, SSDI entitlement and SSI eligibility.

Ever applied for public disability program benefits (Social Security Disability Insurance (SSDI) or disability-related Supplemental Security Income (SSI))

时间窗: From initial randomization (randomization occurred between 2001-2004) through 2017

This is based on Social Security Administration data on applications for SSDI and SSI.

次要结局

  • Ever received disability-related Supplemental Security Income (SSI) benefits(This measure will capture program participation occurring between randomization (occurred between 2001-2004) through 2017)
  • Received Social Security Disability Insurance (SSDI) benefits(12-month intervals relative to randomization occurring between 2001-2017)
  • Received Social Security Disability Insurance (SSDI) or disability-related Supplemental Security Income (SSI) benefits(12-month intervals relative to randomization occurring between 2001-2017)
  • Ever applied for disability-related Supplemental Security Income (SSI) benefits(From initial randomization (occurred between 2001-2004) through 2017)
  • Total person-months of Social Security Disability Insurance (SSDI) benefits received(From initial randomization (occurred between 2001-2004) through 2017)
  • Ever received Social Security Disability Insurance (SSDI) benefits(This measure will capture program participation occurring between randomization (occurred between 2001-2004) through 2017)
  • Ever applied for Social Security Disability Insurance (SSDI) benefits(From initial randomization (occurred between 2001-2004) through 2017)
  • Total person-months of disability-related Supplemental Security Income (SSI) benefits received(From initial randomization (occurred between 2001-2004) through 2017)
  • Total disability-related Supplemental Security Income (SSI) payments(From initial randomization (occurred between 2001-2004) through 2017)
  • Total disability payments (Social Security Disability Insurance (SSDI) and disability-related Supplemental Security Income (SSI))(From initial randomization (occurred between 2001-2004) through 2017)
  • Received disability-related Supplemental Security Income (SSI) benefits(12-month intervals relative to randomization occurring between 2001-2017)
  • Total person-months of Social Security Disability Insurance (SSDI) or disability-related Supplemental Security Income (SSI) benefits received(From initial randomization (occurred between 2001-2004) through 2017)
  • Total Social Security Disability Insurance (SSDI) payments(From initial randomization (occurred between 2001-2004) through 2017.)
  • Application for Social Security Disability Insurance (SSDI) benefits(12-month intervals relative to randomization occurring between 2001-2017.)
  • Application for disability-related Supplemental Security Income (SSI) benefits(12-month intervals relative to randomization occurring between 2001-2017)
  • Application for Social Security Disability Insurance (SSDI) or disability-related Supplemental Security Income (SSI) benefits.(12-month intervals relative to randomization occurring between 2001-2017)

研究者

申办方类型
Other
责任方
Sponsor

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