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The Effects of an Intensive Lifestyle Intervention on Employment, Earnings, and Retirement

The Effects of an Intensive Lifestyle Intervention for Type 2 Diabetes on Employment, Earnings, and Retirement

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04563598
Enrollment
3091
Registered
2020-09-24
Start date
2016-12-19
Completion date
2023-06-30
Last updated
2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

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, or DSE). The ILI successfully reduced weight, improved diabetes control, and functional status, among other outcomes. In this study, the investigators will compare employment, earnings, and retirement between the ILI and the control group during and after the intervention period (2001-2018).

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, or DSE).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 employment, earnings, and retirement between the ILI and the control group during and after the intervention period (2001-2018). The investigators will determine ILI-versus-control differences in employment, earnings, and retirement in each year after randomization, relative to a pre-randomization assessment period. The investigators will also investigate ILI-versus-control differences in cumulative years of employment and earnings after randomization which occurred between 2001-2004. The investigators will use multivariate regressions controlling for baseline participant characteristics and clinic site and also survival analyses that estimate whether the time until retirement differs between the ILI and control groups.

Interventions

Lifestyle intervention focused on weight loss through diet and physical activity

Behavioral intervention focused on diabetes support and education

Sponsors

University of Southern California
CollaboratorOTHER
Wake Forest University
CollaboratorOTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
University of Minnesota
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No

Inclusion 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 Social Security Administration databases * Were successfully linked to Social Security Administration data

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Employed (any earnings from employment or self-employment) by study year (all study participants)12-month intervals relative to randomization occurring between 2001-2018This measure is based on Social Security Administration data on earnings
Total earnings from employment and/or self-employment by study year (all study participants)12-month intervals relative to randomization occurring between 2001-2018This measure is based on Social Security Administration data on earnings; earnings for unemployed study participants will be captured as zeros.

Secondary

MeasureTime frameDescription
Ever received Supplemental Security Income (SSI) benefits at age 65 since randomization (all study participants)From initial randomization (occurred between 2001-2004) through 2018This measure is based on Social Security Administration data indicating SSI benefits and SSI eligibility.
Retired (any Social Security retirement entitlement/election) by study year (all study participants)12-month intervals relative to randomization occurring between 2001-2018This measure is based on Social Security Administration data on retirement entitlement/election
Total earnings from employment and/or self-employment by study year (excluding unemployed study participants)12-month intervals relative to randomization occurring between 2001-2018This measure is based on Social Security Administration data on earnings
Total person-years from randomization to retirement (all study participants)From initial randomization (occurred between 2001-2004) through 2018This measure is based on Social Security Administration data on retirement entitlement/election
Total person-years employed since randomization (all study participants)From initial randomization (occurred between 2001-2004) through 2018This measure is based on Social Security Administration data on earnings
Ever employed (any earnings from employment or self-employment) after randomization (all study participants)From initial randomization (occurred between 2001-2004) through 2018This measure is based on Social Security Administration data on earnings
Total earnings from employment and/or self-employment since randomization (all study participants)From initial randomization (occurred between 2001-2004) through 2018This measure is based on Social Security Administration data on earnings

Other

MeasureTime frameDescription
Ever retired after randomization (all study participants)From initial randomization (occurred between 2001-2004) through 2018This measure is based on Social Security Administration data on retirement entitlement/election
Ever worked past minimum retirement age (partial benefits, age 62; excluding unemployed study participants)From initial randomization (occurred between 2001-2004) through 2018This measure is based on Social Security Administration data on earnings
Ever worked past minimum retirement age (full benefits, age 65 or 66 depending on date of birth; excluding unemployed study participants)From initial randomization (occurred between 2001-2004) through 2018This measure is based on Social Security Administration data on earnings
Total compensation (from employment, self-employment, pensions, and distributions from retirement accounts) after randomization (all study participants)From initial randomization (occurred between 2001-2004) through 2018This measure is based on Social Security Administration data on compensation
Ever employed (any earnings from employment and/or self-employment) during first 10 years after randomization (all study participants)From initial randomization (occurred between 2001-2004) through 2014This measure is based on Social Security Administration data on earnings
Total person-years employed (any earnings from employment and/or self-employment) during first 10 years after randomization (all study participants)From initial randomization (occurred between 2001-2004) through 2014This measure is based on Social Security Administration data on earnings
Total earnings (from employment and/or self-employment) during first 10 years after randomization (all study participants)From initial randomization (occurred between 2001-2004) through 2014This measure is based on Social Security Administration data on earnings
Total compensation (from employment, self-employment, pensions, and distributions from retirement accounts) during first 10 years after randomization (all study participants)From initial randomization (occurred between 2001-2004) through 2014This measure is based on Social Security Administration data on compensation
Ever retired during first 10 years after randomization (all study participants)From initial randomization (occurred between 2001-2004) through 2014This measure is based on Social Security Administration data on retirement entitlement/election
Number of employers (unique employer IDs) per study year (excluding unemployed study participants)12-month intervals relative to randomization occurring between 2001-2018This measure is based on Social Security Administration data on employers
Started a new job (new employer ID) by study year (all study participants)12-month intervals relative to randomization occurring between 2001-2018This measure is based on Social Security Administration data on employment
Started a new job (new employer ID) by study year (excluding unemployed study participants)12-month intervals relative to randomization occurring between 2001-2018This measure is based on Social Security Administration data on employment
Received any Supplemental Security Income (SSI) benefits at age 65 since randomization (all study participants)12-month intervals relative to randomization occurring between 2001-2018This measure is based on Social Security Administration data indicating SSI benefits and SSI eligibility
Received any self-employment income by study year (all study participants)12-month intervals relative to randomization occurring between 2001-2018This measure is based on Social Security Administration data on earnings
Received any income from pensions or distributions from retirement accounts by study year (all study participants)12-month intervals relative to randomization occurring between 2001-2018This measure is based on Social Security Administration data on earnings
Total compensation (from employment, self-employment, pensions, and distributions from retirement accounts (all study participants)12-month intervals relative to randomization occurring between 2001-2018This measure is based on Social Security Administration data on compensation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026