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

Completed

• Conditions: Diabetes Mellitus Type 2
• Interventions: Behavioral: Diabetes support and education (DSE); Behavioral: Intensive lifestyle intervention (ILI)

• Registration Number: NCT04515745
• Lead Sponsor: University of Minnesota

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2016-12-19
• Study First Submitted: 2020-08-12
• Study First Submitted QC: 2020-08-12
• Study First Posted: 2020-08-17
• Primary Completion: 2022-06-30
• Study Completion: 2023-10-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-03
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3091

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

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Exclusion Criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DSE/Control group	Diabetes support and education (DSE)	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.
ILI/Treatment group	Intensive lifestyle intervention (ILI)	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.

Primary Outcome Measures

Name	Time	Method
Ever received public disability program benefits (Social Security Disability Insurance (SSDI) or disability-related Supplemental Security Income (SSI))	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))	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 Outcome Measures

Name	Time	Method
Ever received disability-related Supplemental Security Income (SSI) benefits	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.
Received Social Security Disability Insurance (SSDI) benefits	12-month intervals relative to randomization occurring between 2001-2017	This is based on Social Security Administration data indicating SSDI benefits and SSDI entitlement.
Received Social Security Disability Insurance (SSDI) or disability-related Supplemental Security Income (SSI) benefits	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.
Ever applied for disability-related Supplemental Security Income (SSI) benefits	From initial randomization (occurred between 2001-2004) through 2017	This measure is based on Social Security Administration data on applications for SSI.
Total person-months of Social Security Disability Insurance (SSDI) benefits received	From initial randomization (occurred between 2001-2004) through 2017	This is based on Social Security Administration data on SSDI and SSDI entitlement.
Ever received Social Security Disability Insurance (SSDI) benefits	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.
Ever applied for Social Security Disability Insurance (SSDI) benefits	From initial randomization (occurred between 2001-2004) through 2017	This measure is based on Social Security Administration data on applications for SSDI.
Total person-months of disability-related Supplemental Security Income (SSI) benefits received	From initial randomization (occurred between 2001-2004) through 2017	This is based on Social Security Administration data on SSI benefits and SSI eligibility.
Total disability-related Supplemental Security Income (SSI) payments	From initial randomization (occurred between 2001-2004) through 2017	This is based on Social Security Administration data on SSI payments, adjusting for inflation.
Total disability payments (Social Security Disability Insurance (SSDI) and disability-related Supplemental Security Income (SSI))	From initial randomization (occurred between 2001-2004) through 2017	This based on Social Security Administration data on SSDI and SSI payments, adjusted for inflation.
Received disability-related Supplemental Security Income (SSI) benefits	12-month intervals relative to randomization occurring between 2001-2017	This is based on Social Security Administration data indicating SSI benefits and SSI eligibility.
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	This is based on Social Security Administration data on SSDI and SSI benefits, SSDI entitlement and SSI eligibility.
Total Social Security Disability Insurance (SSDI) payments	From initial randomization (occurred between 2001-2004) through 2017.	This is based on Social Security Administration data on SSDI payments, adjusting for inflation.
Application for Social Security Disability Insurance (SSDI) benefits	12-month intervals relative to randomization occurring between 2001-2017.	This measure is based on Social Security Administration data on applications for SSDI.
Application for disability-related Supplemental Security Income (SSI) benefits	12-month intervals relative to randomization occurring between 2001-2017	This is based on Social Security Administration data on applications for SSI.
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	This measure is based on Social Security Administration data on applications for SSDI and SSI.