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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Intensive lifestyle intervention (ILI)
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: Diabetes support and education (DSE)
Behavioral intervention focused on diabetes support and education

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Minnesota

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Southern California
Wake Forest University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 19, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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