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

Study Overview
=================
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.

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

Conditions
-----------------
Diabetes Mellitus Type 2

Intervention / Treatment
-----------------
* Behavioral: Intensive lifestyle intervention (ILI)
* Behavioral: Diabetes support and education (DSE)


Participation Criteria
=================
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: -

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ILI/Treatment group<br>This group includes Look AHEAD participants who were initially assigned to the intensive lifestyle intervention (ILI), consented to administrative data linkages, and were successfully linked to Social Security Administration (SSA) databases. | Behavioral: Intensive lifestyle intervention (ILI)<br>* Lifestyle intervention focused on weight loss through diet and physical activity<br>|
| DSE/Control group<br>This group includes Look AHEAD participants who were initially assigned to the diabetes support and education (DSE) control arm, consented to administrative data linkages, and were successfully linked to SSA databases. | Behavioral: Diabetes support and education (DSE)<br>* Behavioral intervention focused on diabetes support and education<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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. | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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. | 
| 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 | 
| 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 |