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Completed

NCT Number: NCT04515745

The Effects of an Intensive Lifestyle Intervention for Type 2 Diabetes on Disability Insurance

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).

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Key information

Conditions

Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

(Note: age limits above are at time of randomization, which occurred between 2001-2004)

Inclusion criteria

  • 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

Exclusion criteria

-

Treatment and study plan

Intensive Lifestyle Intervention (ILI)

Behavioral

Lifestyle intervention focused on weight loss through diet and physical activity

Diabetes support and education (DSE)

Behavioral

Behavioral intervention focused on diabetes support and education

Primary outcomes

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

    Time frame: 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.

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

    Time frame: From initial randomization (randomization occurred between 2001-2004) through 2017

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

Secondary outcomes

  1. Ever received Social Security Disability Insurance (SSDI) benefits

    Time frame: This measure will capture program participation occurring between randomization (occurred between 2001-2004) through 2017

    This is based on Social Security Administration data indicating SSDI benefits and SSDI entitlement.

  2. Ever received disability-related Supplemental Security Income (SSI) benefits

    Time frame: This measure will capture program participation occurring between randomization (occurred between 2001-2004) through 2017

    This is based on Social Security Administration data indicating SSI benefits and SSI eligibility.

  3. Ever applied for Social Security Disability Insurance (SSDI) benefits

    Time frame: From initial randomization (occurred between 2001-2004) through 2017

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

  4. Ever applied for disability-related Supplemental Security Income (SSI) benefits

    Time frame: From initial randomization (occurred between 2001-2004) through 2017

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

  5. Total person-months of Social Security Disability Insurance (SSDI) benefits received

    Time frame: From initial randomization (occurred between 2001-2004) through 2017

    This is based on Social Security Administration data on SSDI and SSDI entitlement.

  6. Total person-months of disability-related Supplemental Security Income (SSI) benefits received

    Time frame: From initial randomization (occurred between 2001-2004) through 2017

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

  7. Total person-months of Social Security Disability Insurance (SSDI) or disability-related Supplemental Security Income (SSI) benefits received

    Time frame: From initial 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.

  8. Total Social Security Disability Insurance (SSDI) payments

    Time frame: From initial randomization (occurred between 2001-2004) through 2017.

    This is based on Social Security Administration data on SSDI payments, adjusting for inflation.

  9. Total disability-related Supplemental Security Income (SSI) payments

    Time frame: From initial randomization (occurred between 2001-2004) through 2017

    This is based on Social Security Administration data on SSI payments, adjusting for inflation.

  10. Total disability payments (Social Security Disability Insurance (SSDI) and disability-related Supplemental Security Income (SSI))

    Time frame: From initial randomization (occurred between 2001-2004) through 2017

    This based on Social Security Administration data on SSDI and SSI payments, adjusted for inflation.

  11. Received Social Security Disability Insurance (SSDI) benefits

    Time frame: 12-month intervals relative to randomization occurring between 2001-2017

    This is based on Social Security Administration data indicating SSDI benefits and SSDI entitlement.

  12. Received disability-related Supplemental Security Income (SSI) benefits

    Time frame: 12-month intervals relative to randomization occurring between 2001-2017

    This is based on Social Security Administration data indicating SSI benefits and SSI eligibility.

  13. Received Social Security Disability Insurance (SSDI) or disability-related Supplemental Security Income (SSI) benefits

    Time frame: 12-month intervals relative to randomization occurring between 2001-2017

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

  14. Application for Social Security Disability Insurance (SSDI) benefits

    Time frame: 12-month intervals relative to randomization occurring between 2001-2017.

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

  15. Application for disability-related Supplemental Security Income (SSI) benefits

    Time frame: 12-month intervals relative to randomization occurring between 2001-2017

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

  16. Application for Social Security Disability Insurance (SSDI) or disability-related Supplemental Security Income (SSI) benefits.

    Time frame: 12-month intervals relative to randomization occurring between 2001-2017

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

Other outcomes

  1. Ever received disability benefits (Social Security Disability Insurance (SSDI) or disability-related Supplemental Security Income (SSI) benefits) within 8 years of randomization

    Time frame: The first 8 years following randomization, which occurred from 2001 to 2004.

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

  2. Ever received Social Security Disability Insurance (SSDI) benefits within 8 years of randomization

    Time frame: This measure will capture program participation within 8 years of randomization (occurred 2001-2004)

    This is based on Social Security Administration data indicating SSDI benefits received and SSDI entitlement.

  3. Ever received disability-related Supplemental Security Income (SSI) benefits within 8 years of randomization

    Time frame: This measure will capture program participation within 8 years of randomization (occurred 2001-2004)

    This is based on Social Security Administration data indicating SSI benefits received and SSI eligibility.

  4. Ever applied for disability benefits (Social Security Disability Insurance (SSDI) or disability-related Supplemental Security Income (SSI) benefits within 8 years of randomization

    Time frame: The first 8 years following randomization, which occurred from 2001 to 2004.

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

  5. Ever applied for Social Security Disability Insurance (SSDI) benefits within 8 years of randomization

    Time frame: The first 8 years following randomization, which occurred from 2001 to 2004.

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

  6. Ever applied for disability-related Supplemental Security Income (SSI) benefits within 8 years of randomization

    Time frame: The first 8 years following randomization, which occurred from 2001 to 2004.

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

  7. Total person-months of Social Security Disability Insurance (SSDI) or disability-related Supplemental Security Income (SSI) benefits received within 8 years of randomization

    Time frame: The first 8 years following randomization, which occurred from 2001 to 2004.

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

  8. Total person-months of Social Security Disability Insurance (SSDI) benefits received within 8 years of randomization

    Time frame: The first 8 years following randomization, which occurred from 2001 to 2004.

    This is based on Social Security Administration data on SSDI and SSDI entitlement.

  9. Total person-months of disability-related Supplemental Security Income (SSI) benefits received within 8 years of randomization

    Time frame: The first 8 years following randomization, which occurred from 2001 to 2004.

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

  10. Person-months of Social Security Disability Insurance (SSDI) benefits received

    Time frame: 12-month intervals relative to randomization occurring between 2001-2017

    This is based on Social Security Administration data on SSDI and SSDI entitlement.

  11. Person-months of disability-related Supplemental Security Income (SSI) benefits received

    Time frame: 12-month intervals relative to randomization occurring between 2001-2017

    This is based on Social Security Administration data on SSI and SSI eligibility.

  12. Person-months of Social Security Disability Insurance (SSDI) or disability-related Supplemental Security Income (SSI) benefits received

    Time frame: 12-month intervals relative to randomization occurring between 2001-2017

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

  13. Social Security Disability Insurance (SSDI) payments

    Time frame: 12-month intervals relative to randomization occurring between 2001-2017

    This is based on Social Security Administration data on SSDI payments, adjusting for inflation.

  14. Disability-related Supplemental Security Income (SSI) payments

    Time frame: 12-month intervals relative to randomization occurring between 2001-2017

    This is based on Social Security Administration data on SSI payments, adjusting for inflation.

  15. Disability payments (Social Security Disability Insurance (SSDI) and disability-related Supplemental Security Income (SSI))

    Time frame: 12-month intervals relative to randomization occurring between 2001-2017

    This based on Social Security Administration data on SSDI and SSI payments, adjusted for inflation.

  16. Labor force participation conditional on enrollment in disability programs

    Time frame: 12-month intervals relative to randomization occurring between 2001-2017

    This is based on Social Security Administration data indicating labor force participation among recipients of Social Security Disability Insurance and Supplemental Security Income.

  17. Annual labor market earnings conditional on enrollment in disability programs

    Time frame: 12-month intervals relative to randomization occurring between 2001-2017

    This is based on Social Security Administration data indicating earnings among recipients of Social Security Disability Insurance and Supplemental Security Income.

  18. Ever participated in labor force conditional on enrollment in disability programs.

    Time frame: From initial randomization (occurred between 2001-2004) through 2017

    This is based on Social Security Administration data indicating labor force participation while individuals received Social Security Disability Insurance or Supplemental Security Income benefits.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • University of Southern California
  • Wake Forest University

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2022
Study completion
2023
First posted
Aug 17, 2020
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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