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

Diabetes Mellitus Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04515745
• Other study ID #: UP-16-00706-2
• Secondary ID: 5R01DK107552
• Status: Completed
• Start date: December 19, 2016
• Est. completion date: October 30, 2023

Study information

• Verified date: November 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3091
• Est. completion date: October 30, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

(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:

-

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Intensive lifestyle intervention (ILI)
Lifestyle intervention focused on weight loss through diet and physical activity
• Diabetes support and education (DSE)
Behavioral intervention focused on diabetes support and education

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University of Minnesota	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Southern California, Wake Forest University

References & Publications (1)

Look AHEAD Research Group; Wing RR, Bolin P, Brancati FL, Bray GA, Clark JM, Coday M, Crow RS, Curtis JM, Egan CM, Espeland MA, Evans M, Foreyt JP, Ghazarian S, Gregg EW, Harrison B, Hazuda HP, Hill JO, Horton ES, Hubbard VS, Jakicic JM, Jeffery RW, Johnson KC, Kahn SE, Kitabchi AE, Knowler WC, Lewis CE, Maschak-Carey BJ, Montez MG, Murillo A, Nathan DM, Patricio J, Peters A, Pi-Sunyer X, Pownall H, Reboussin D, Regensteiner JG, Rickman AD, Ryan DH, Safford M, Wadden TA, Wagenknecht LE, West DS, Williamson DF, Yanovski SZ. Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes. N Engl J Med. 2013 Jul 11;369(2):145-54. doi: 10.1056/NEJMoa1212914. Epub 2013 Jun 24. Erratum In: N Engl J Med. 2014 May 8;370(19):1866. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ever received disability benefits (Social Security Disability Insurance (SSDI) or disability-related Supplemental Security Income (SSI) benefits) within 8 years of randomization	This is based on Social Security Administration data on SSDI and SSI benefits, SSDI entitlement and SSI eligibility.	The first 8 years following randomization, which occurred from 2001 to 2004.
Other	Ever received Social Security Disability Insurance (SSDI) benefits within 8 years of randomization	This is based on Social Security Administration data indicating SSDI benefits received and SSDI entitlement.	This measure will capture program participation within 8 years of randomization (occurred 2001-2004)
Other	Ever received disability-related Supplemental Security Income (SSI) benefits within 8 years of randomization	This is based on Social Security Administration data indicating SSI benefits received and SSI eligibility.	This measure will capture program participation within 8 years of randomization (occurred 2001-2004)
Other	Ever applied for disability benefits (Social Security Disability Insurance (SSDI) or disability-related Supplemental Security Income (SSI) benefits within 8 years of randomization	This is based on Social Security Administration data indicating applications for SSDI or SSI.	The first 8 years following randomization, which occurred from 2001 to 2004.
Other	Ever applied for Social Security Disability Insurance (SSDI) benefits within 8 years of randomization	This is based on Social Security Administration data indicating applications for SSDI.	The first 8 years following randomization, which occurred from 2001 to 2004.
Other	Ever applied for disability-related Supplemental Security Income (SSI) benefits within 8 years of randomization	This is based on Social Security Administration data indicating applications for SSI.	The first 8 years following randomization, which occurred from 2001 to 2004.
Other	Total person-months of Social Security Disability Insurance (SSDI) or disability-related Supplemental Security Income (SSI) benefits received within 8 years of randomization	This is based on Social Security Administration data on SSDI and SSI benefits, SSDI entitlement and SSI eligibility.	The first 8 years following randomization, which occurred from 2001 to 2004.
Other	Total person-months of Social Security Disability Insurance (SSDI) benefits received within 8 years of randomization	This is based on Social Security Administration data on SSDI and SSDI entitlement.	The first 8 years following randomization, which occurred from 2001 to 2004.
Other	Total person-months of disability-related Supplemental Security Income (SSI) benefits received within 8 years of randomization	This is based on Social Security Administration data on SSI benefits and SSI eligibility.	The first 8 years following randomization, which occurred from 2001 to 2004.
Other	Person-months of Social Security Disability Insurance (SSDI) benefits received	This is based on Social Security Administration data on SSDI and SSDI entitlement.	12-month intervals relative to randomization occurring between 2001-2017
Other	Person-months of disability-related Supplemental Security Income (SSI) benefits received	This is based on Social Security Administration data on SSI and SSI eligibility.	12-month intervals relative to randomization occurring between 2001-2017
Other	Person-months of Social Security Disability Insurance (SSDI) or disability-related Supplemental Security Income (SSI) benefits received	This is based on Social Security Administration data on SSDI and SSI benefits, SSDI entitlement and SSI eligibility.	12-month intervals relative to randomization occurring between 2001-2017
Other	Social Security Disability Insurance (SSDI) payments	This is based on Social Security Administration data on SSDI payments, adjusting for inflation.	12-month intervals relative to randomization occurring between 2001-2017
Other	Disability-related Supplemental Security Income (SSI) payments	This is based on Social Security Administration data on SSI payments, adjusting for inflation.	12-month intervals relative to randomization occurring between 2001-2017
Other	Disability payments (Social Security Disability Insurance (SSDI) and disability-related Supplemental Security Income (SSI))	This based on Social Security Administration data on SSDI and SSI payments, adjusted for inflation.	12-month intervals relative to randomization occurring between 2001-2017
Other	Labor force participation conditional on enrollment in disability programs	This is based on Social Security Administration data indicating labor force participation among recipients of Social Security Disability Insurance and Supplemental Security Income.	12-month intervals relative to randomization occurring between 2001-2017
Other	Annual labor market earnings conditional on enrollment in disability programs	This is based on Social Security Administration data indicating earnings among recipients of Social Security Disability Insurance and Supplemental Security Income.	12-month intervals relative to randomization occurring between 2001-2017
Other	Ever participated in labor force conditional on enrollment in disability programs.	This is based on Social Security Administration data indicating labor force participation while individuals received Social Security Disability Insurance or Supplemental Security Income benefits.	From initial randomization (occurred between 2001-2004) through 2017
Primary	Ever received public disability program benefits (Social Security Disability Insurance (SSDI) or disability-related Supplemental Security Income (SSI))	This is based on Social Security Administration data on SSDI and SSI benefits, SSDI entitlement and SSI eligibility.	This measure will capture program participation between randomization (randomization occurred between 2001-2004) through 2017
Primary	Ever applied for public disability program benefits (Social Security Disability Insurance (SSDI) or disability-related Supplemental Security Income (SSI))	This is based on Social Security Administration data on applications for SSDI and SSI.	From initial randomization (randomization occurred between 2001-2004) through 2017
Secondary	Ever received Social Security Disability Insurance (SSDI) benefits	This is based on Social Security Administration data indicating SSDI benefits and SSDI entitlement.	This measure will capture program participation occurring between randomization (occurred between 2001-2004) through 2017
Secondary	Ever received disability-related Supplemental Security Income (SSI) benefits	This is based on Social Security Administration data indicating SSI benefits and SSI eligibility.	This measure will capture program participation occurring between randomization (occurred between 2001-2004) through 2017
Secondary	Ever applied for Social Security Disability Insurance (SSDI) benefits	This measure is based on Social Security Administration data on applications for SSDI.	From initial randomization (occurred between 2001-2004) through 2017
Secondary	Ever applied for disability-related Supplemental Security Income (SSI) benefits	This measure is based on Social Security Administration data on applications for SSI.	From initial randomization (occurred between 2001-2004) through 2017
Secondary	Total person-months of Social Security Disability Insurance (SSDI) benefits received	This is based on Social Security Administration data on SSDI and SSDI entitlement.	From initial randomization (occurred between 2001-2004) through 2017
Secondary	Total person-months of disability-related Supplemental Security Income (SSI) benefits received	This is based on Social Security Administration data on SSI benefits and SSI eligibility.	From initial randomization (occurred between 2001-2004) through 2017
Secondary	Total person-months of Social Security Disability Insurance (SSDI) or disability-related Supplemental Security Income (SSI) benefits received	This is based on Social Security Administration data on SSDI and SSI benefits, SSDI entitlement and SSI eligibility.	From initial randomization (occurred between 2001-2004) through 2017
Secondary	Total Social Security Disability Insurance (SSDI) payments	This is based on Social Security Administration data on SSDI payments, adjusting for inflation.	From initial randomization (occurred between 2001-2004) through 2017.
Secondary	Total disability-related Supplemental Security Income (SSI) payments	This is based on Social Security Administration data on SSI payments, adjusting for inflation.	From initial randomization (occurred between 2001-2004) through 2017
Secondary	Total disability payments (Social Security Disability Insurance (SSDI) and disability-related Supplemental Security Income (SSI))	This based on Social Security Administration data on SSDI and SSI payments, adjusted for inflation.	From initial randomization (occurred between 2001-2004) through 2017
Secondary	Received Social Security Disability Insurance (SSDI) benefits	This is based on Social Security Administration data indicating SSDI benefits and SSDI entitlement.	12-month intervals relative to randomization occurring between 2001-2017
Secondary	Received disability-related Supplemental Security Income (SSI) benefits	This is based on Social Security Administration data indicating SSI benefits and SSI eligibility.	12-month intervals relative to randomization occurring between 2001-2017
Secondary	Received Social Security Disability Insurance (SSDI) or disability-related Supplemental Security Income (SSI) benefits	This is based on Social Security Administration data on SSDI and SSI benefits, SSDI entitlement and SSI eligibility.	12-month intervals relative to randomization occurring between 2001-2017
Secondary	Application for Social Security Disability Insurance (SSDI) benefits	This measure is based on Social Security Administration data on applications for SSDI.	12-month intervals relative to randomization occurring between 2001-2017.
Secondary	Application for disability-related Supplemental Security Income (SSI) benefits	This is based on Social Security Administration data on applications for SSI.	12-month intervals relative to randomization occurring between 2001-2017
Secondary	Application for Social Security Disability Insurance (SSDI) or disability-related Supplemental Security Income (SSI) benefits.	This measure is based on Social Security Administration data on applications for SSDI and SSI.	12-month intervals relative to randomization occurring between 2001-2017