Clinical trial NCT04515745: The Effects of an Intensive Lifestyle Intervention for Type 2 Diabetes on Disability Insurance
Official title: The Effects of an Intensive Lifestyle Intervention for Type 2 Diabetes on Disability Insurance Applications, Receipt, and Payments
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus Type 2
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: University of Southern California
name: Wake Forest University
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-08-17
Enrollment: 3091
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes Look AHEAD participants that consented to administrative data linkages, provided individual identifiers that could be linked with SSA data, and were successfully linked to SSA data.

Brief 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).

Detailed 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.

Eligibility criteria: (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:

-

Primary outcomes:
measure: Ever received public disability program benefits (Social Security Disability Insurance (SSDI) or disability-related Supplemental Security Income (SSI))
timeFrame: This measure will capture program participation between randomization (randomization occurred between 2001-2004) through 2017
measure: Ever applied for public disability program benefits (Social Security Disability Insurance (SSDI) or disability-related Supplemental Security Income (SSI))
timeFrame: From initial randomization (randomization occurred between 2001-2004) through 2017
Secondary outcomes:
measure: Ever received Social Security Disability Insurance (SSDI) benefits
timeFrame: This measure will capture program participation occurring between randomization (occurred between 2001-2004) through 2017
measure: Ever received disability-related Supplemental Security Income (SSI) benefits
timeFrame: This measure will capture program participation occurring between randomization (occurred between 2001-2004) through 2017
measure: Ever applied for Social Security Disability Insurance (SSDI) benefits
timeFrame: From initial randomization (occurred between 2001-2004) through 2017
measure: Ever applied for disability-related Supplemental Security Income (SSI) benefits
timeFrame: From initial randomization (occurred between 2001-2004) through 2017
measure: Total person-months of Social Security Disability Insurance (SSDI) benefits received
timeFrame: From initial randomization (occurred between 2001-2004) through 2017
measure: Total person-months of disability-related Supplemental Security Income (SSI) benefits received
timeFrame: From initial randomization (occurred between 2001-2004) through 2017
measure: Total person-months of Social Security Disability Insurance (SSDI) or disability-related Supplemental Security Income (SSI) benefits received
timeFrame: From initial randomization (occurred between 2001-2004) through 2017
measure: Total Social Security Disability Insurance (SSDI) payments
timeFrame: From initial randomization (occurred between 2001-2004) through 2017.
measure: Total disability-related Supplemental Security Income (SSI) payments
timeFrame: From initial randomization (occurred between 2001-2004) through 2017
measure: Total disability payments (Social Security Disability Insurance (SSDI) and disability-related Supplemental Security Income (SSI))
timeFrame: From initial randomization (occurred between 2001-2004) through 2017
measure: Received Social Security Disability Insurance (SSDI) benefits
timeFrame: 12-month intervals relative to randomization occurring between 2001-2017
measure: Received disability-related Supplemental Security Income (SSI) benefits
timeFrame: 12-month intervals relative to randomization occurring between 2001-2017
measure: Received Social Security Disability Insurance (SSDI) or disability-related Supplemental Security Income (SSI) benefits
timeFrame: 12-month intervals relative to randomization occurring between 2001-2017
measure: Application for Social Security Disability Insurance (SSDI) benefits
timeFrame: 12-month intervals relative to randomization occurring between 2001-2017.
measure: Application for disability-related Supplemental Security Income (SSI) benefits
timeFrame: 12-month intervals relative to randomization occurring between 2001-2017
measure: Application for Social Security Disability Insurance (SSDI) or disability-related Supplemental Security Income (SSI) benefits.
timeFrame: 12-month intervals relative to randomization occurring between 2001-2017
Other outcomes:
measure: Ever received disability benefits (Social Security Disability Insurance (SSDI) or disability-related Supplemental Security Income (SSI) benefits) within 8 years of randomization
timeFrame: The first 8 years following randomization, which occurred from 2001 to 2004.
measure: Ever received Social Security Disability Insurance (SSDI) benefits within 8 years of randomization
timeFrame: This measure will capture program participation within 8 years of randomization (occurred 2001-2004)
measure: Ever received disability-related Supplemental Security Income (SSI) benefits within 8 years of randomization
timeFrame: This measure will capture program participation within 8 years of randomization (occurred 2001-2004)
measure: Ever applied for disability benefits (Social Security Disability Insurance (SSDI) or disability-related Supplemental Security Income (SSI) benefits within 8 years of randomization
timeFrame: The first 8 years following randomization, which occurred from 2001 to 2004.
measure: Ever applied for Social Security Disability Insurance (SSDI) benefits within 8 years of randomization
timeFrame: The first 8 years following randomization, which occurred from 2001 to 2004.
measure: Ever applied for disability-related Supplemental Security Income (SSI) benefits within 8 years of randomization
timeFrame: The first 8 years following randomization, which occurred from 2001 to 2004.
measure: Total person-months of Social Security Disability Insurance (SSDI) or disability-related Supplemental Security Income (SSI) benefits received within 8 years of randomization
timeFrame: The first 8 years following randomization, which occurred from 2001 to 2004.
measure: Total person-months of Social Security Disability Insurance (SSDI) benefits received within 8 years of randomization
timeFrame: The first 8 years following randomization, which occurred from 2001 to 2004.
measure: Total person-months of disability-related Supplemental Security Income (SSI) benefits received within 8 years of randomization
timeFrame: The first 8 years following randomization, which occurred from 2001 to 2004.
measure: Person-months of Social Security Disability Insurance (SSDI) benefits received
timeFrame: 12-month intervals relative to randomization occurring between 2001-2017
measure: Person-months of disability-related Supplemental Security Income (SSI) benefits received
timeFrame: 12-month intervals relative to randomization occurring between 2001-2017
measure: Person-months of Social Security Disability Insurance (SSDI) or disability-related Supplemental Security Income (SSI) benefits received
timeFrame: 12-month intervals relative to randomization occurring between 2001-2017
measure: Social Security Disability Insurance (SSDI) payments
timeFrame: 12-month intervals relative to randomization occurring between 2001-2017
measure: Disability-related Supplemental Security Income (SSI) payments
timeFrame: 12-month intervals relative to randomization occurring between 2001-2017
measure: Disability payments (Social Security Disability Insurance (SSDI) and disability-related Supplemental Security Income (SSI))
timeFrame: 12-month intervals relative to randomization occurring between 2001-2017
measure: Labor force participation conditional on enrollment in disability programs
timeFrame: 12-month intervals relative to randomization occurring between 2001-2017
measure: Annual labor market earnings conditional on enrollment in disability programs
timeFrame: 12-month intervals relative to randomization occurring between 2001-2017
measure: Ever participated in labor force conditional on enrollment in disability programs.
timeFrame: From initial randomization (occurred between 2001-2004) through 2017
Locations:
Study officials:
affiliation: University of Minnesota
name: Peter J Huckfeldt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.