Diabetes Mellitus Type 2NCT04515745
The Effects of an Intensive Lifestyle Intervention for Type 2 Diabetes on Disability Insurance
An observational study of Diabetes Mellitus Type 2, run by University of Minnesota.
Trial 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"). Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Intensive lifestyle intervention (ILI) and Diabetes support and education (DSE)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 3,091 participants
- Where
- No sites listed yet
- Study dates
- 19 Dec 2016to 30 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- -
About this study
Official title: 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).
Read the 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.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Intensive lifestyle intervention (ILI), Diabetes support and education (DSE)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive lifestyle intervention (ILI)Behavioural
Lifestyle intervention focused on weight loss through diet and physical activity
Diabetes support and education (DSE)Behavioural
Behavioral intervention focused on diabetes support and education
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Intensive lifestyle intervention (ILI) | |
| 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. Receives: Behavioral: Diabetes support and education (DSE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From initial randomization (randomization occurred between 2001-2004) through 2017
Secondary outcomes (16)
Ever received Social Security Disability Insurance (SSDI) benefits
This is based on Social Security Administration data indicating SSDI benefits and SSDI entitlement.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12-month intervals relative to randomization occurring between 2001-2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start19 Dec 2016
- Primary completion30 Jun 2022
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,091 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern California, Wake Forest University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Peter J Huckfeldt, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04515745
- Sponsor's protocol ID
- UP-16-00706-2
- Other IDs
- 5R01DK107552
- Status last verified
- Nov 2023
- First submitted
- 12 Aug 2020
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Use of Social Security Administration data is restricted under a data use agreement between the Social Security Administration and Wake Forest.
Publications
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.
PubMed 23796131
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of an Intensive Lifestyle Intervention for Type 2 Diabetes on Disability Insurance Applications, Receipt, and Payments
- ClinicalTrials.gov ID
- NCT04515745
- Acronym / sponsor ID
- UP-16-00706-2
- Conditions
- Diabetes Mellitus Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,091 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- University of Southern California, Wake Forest University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 19 Dec 2016 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 17 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ILI/Treatment group | – | Behavioral: 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. |
| DSE/Control group | – | Behavioral: 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. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive lifestyle intervention (ILI)Lifestyle intervention focused on weight loss through diet and physical activity | Behavioural | ILI/Treatment group |
| Diabetes support and education (DSE)Behavioral intervention focused on diabetes support and education | Behavioural | DSE/Control group |
Primary outcome
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.
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.
16 secondary outcomes
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
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
Ever applied for Social Security Disability Insurance (SSDI) benefits
Time frame: 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
Total person-months of Social Security Disability Insurance (SSDI) benefits received
Time frame: 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
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
Total Social Security Disability Insurance (SSDI) payments
Time frame: 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
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
Received Social Security Disability Insurance (SSDI) benefits
Time frame: 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
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
Application for Social Security Disability Insurance (SSDI) benefits
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Background: PubMed 23796131Look 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.
- Individual participant dataSharing planned: No. Use of Social Security Administration data is restricted under a data use agreement between the Social Security Administration and Wake Forest.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter J Huckfeldt, PhD principal investigator
University of Minnesota
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus Type 2, run by University of Minnesota.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04515745, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.