- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04515745
The Effects of an Intensive Lifestyle Intervention for Type 2 Diabetes on Disability Insurance
November 3, 2023 updated by: University of Minnesota
The Effects of an Intensive Lifestyle Intervention for Type 2 Diabetes on Disability Insurance Applications, Receipt, and Payments
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
3091
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
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.
Description
(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:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
ILI/Treatment group
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.
|
Lifestyle intervention focused on weight loss through diet and physical activity
|
DSE/Control group
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 intervention focused on diabetes support and education
|
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))
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.
|
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))
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.
|
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
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.
|
This measure will capture program participation occurring between randomization (occurred between 2001-2004) through 2017
|
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.
|
This measure will capture program participation occurring between randomization (occurred between 2001-2004) through 2017
|
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.
|
From initial randomization (occurred between 2001-2004) through 2017
|
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.
|
From initial randomization (occurred between 2001-2004) through 2017
|
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.
|
From initial randomization (occurred between 2001-2004) through 2017
|
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.
|
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
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.
|
From initial randomization (occurred between 2001-2004) through 2017
|
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.
|
From initial randomization (occurred between 2001-2004) through 2017.
|
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.
|
From initial randomization (occurred between 2001-2004) through 2017
|
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.
|
From initial randomization (occurred between 2001-2004) through 2017
|
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-month intervals relative to randomization occurring between 2001-2017
|
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.
|
12-month intervals relative to randomization occurring between 2001-2017
|
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.
|
12-month intervals relative to randomization occurring between 2001-2017
|
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.
|
12-month intervals relative to randomization occurring between 2001-2017.
|
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.
|
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.
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.
|
12-month intervals relative to randomization occurring between 2001-2017
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
The first 8 years following randomization, which occurred from 2001 to 2004.
|
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.
|
This measure will capture program participation within 8 years of randomization (occurred 2001-2004)
|
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.
|
This measure will capture program participation within 8 years of randomization (occurred 2001-2004)
|
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.
|
The first 8 years following randomization, which occurred from 2001 to 2004.
|
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.
|
The first 8 years following randomization, which occurred from 2001 to 2004.
|
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.
|
The first 8 years following randomization, which occurred from 2001 to 2004.
|
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.
|
The first 8 years following randomization, which occurred from 2001 to 2004.
|
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.
|
The first 8 years following randomization, which occurred from 2001 to 2004.
|
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.
|
The first 8 years following randomization, which occurred from 2001 to 2004.
|
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.
|
12-month intervals relative to randomization occurring between 2001-2017
|
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-month intervals relative to randomization occurring between 2001-2017
|
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.
|
12-month intervals relative to randomization occurring between 2001-2017
|
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.
|
12-month intervals relative to randomization occurring between 2001-2017
|
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.
|
12-month intervals relative to randomization occurring between 2001-2017
|
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.
|
12-month intervals relative to randomization occurring between 2001-2017
|
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.
|
12-month intervals relative to randomization occurring between 2001-2017
|
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.
|
12-month intervals relative to randomization occurring between 2001-2017
|
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.
|
From initial randomization (occurred between 2001-2004) through 2017
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Peter J Huckfeldt, PhD, University of Minnesota
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 19, 2016
Primary Completion (Actual)
June 30, 2022
Study Completion (Actual)
October 30, 2023
Study Registration Dates
First Submitted
August 12, 2020
First Submitted That Met QC Criteria
August 12, 2020
First Posted (Actual)
August 17, 2020
Study Record Updates
Last Update Posted (Actual)
November 7, 2023
Last Update Submitted That Met QC Criteria
November 3, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UP-16-00706-2
- 5R01DK107552 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Use of Social Security Administration data is restricted under a data use agreement between the Social Security Administration and Wake Forest.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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