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Completed

NCT Number: NCT04563598

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

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).

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

(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

-

Treatment and study plan

Intensive Lifestyle Intervention (ILI)

Behavioral

Lifestyle intervention focused on weight loss through diet and physical activity

Diabetes support and education (DSE)

Behavioral

Behavioral intervention focused on diabetes support and education

Primary outcomes

  1. Employed (any earnings from employment or self-employment) by study year (all study participants)

    Time frame: 12-month intervals relative to randomization occurring between 2001-2018

    This measure is based on Social Security Administration data on earnings

  2. Total earnings from employment and/or self-employment by study year (all study participants)

    Time frame: 12-month intervals relative to randomization occurring between 2001-2018

    This measure is based on Social Security Administration data on earnings; earnings for unemployed study participants will be captured as zeros.

Secondary outcomes

  1. Retired (any Social Security retirement entitlement/election) by study year (all study participants)

    Time frame: 12-month intervals relative to randomization occurring between 2001-2018

    This measure is based on Social Security Administration data on retirement entitlement/election

  2. Total earnings from employment and/or self-employment by study year (excluding unemployed study participants)

    Time frame: 12-month intervals relative to randomization occurring between 2001-2018

    This measure is based on Social Security Administration data on earnings

  3. Total person-years from randomization to retirement (all study participants)

    Time frame: From initial randomization (occurred between 2001-2004) through 2018

    This measure is based on Social Security Administration data on retirement entitlement/election

  4. Total person-years employed since randomization (all study participants)

    Time frame: From initial randomization (occurred between 2001-2004) through 2018

    This measure is based on Social Security Administration data on earnings

  5. Ever employed (any earnings from employment or self-employment) after randomization (all study participants)

    Time frame: From initial randomization (occurred between 2001-2004) through 2018

    This measure is based on Social Security Administration data on earnings

  6. Total earnings from employment and/or self-employment since randomization (all study participants)

    Time frame: From initial randomization (occurred between 2001-2004) through 2018

    This measure is based on Social Security Administration data on earnings

  7. Ever received Supplemental Security Income (SSI) benefits at age 65 since randomization (all study participants)

    Time frame: From initial randomization (occurred between 2001-2004) through 2018

    This measure is based on Social Security Administration data indicating SSI benefits and SSI eligibility.

Other outcomes

  1. Number of employers (unique employer IDs) per study year (excluding unemployed study participants)

    Time frame: 12-month intervals relative to randomization occurring between 2001-2018

    This measure is based on Social Security Administration data on employers

  2. Started a new job (new employer ID) by study year (all study participants)

    Time frame: 12-month intervals relative to randomization occurring between 2001-2018

    This measure is based on Social Security Administration data on employment

  3. Started a new job (new employer ID) by study year (excluding unemployed study participants)

    Time frame: 12-month intervals relative to randomization occurring between 2001-2018

    This measure is based on Social Security Administration data on employment

  4. Received any Supplemental Security Income (SSI) benefits at age 65 since randomization (all study participants)

    Time frame: 12-month intervals relative to randomization occurring between 2001-2018

    This measure is based on Social Security Administration data indicating SSI benefits and SSI eligibility

  5. Received any self-employment income by study year (all study participants)

    Time frame: 12-month intervals relative to randomization occurring between 2001-2018

    This measure is based on Social Security Administration data on earnings

  6. Received any income from pensions or distributions from retirement accounts by study year (all study participants)

    Time frame: 12-month intervals relative to randomization occurring between 2001-2018

    This measure is based on Social Security Administration data on earnings

  7. Total compensation (from employment, self-employment, pensions, and distributions from retirement accounts (all study participants)

    Time frame: 12-month intervals relative to randomization occurring between 2001-2018

    This measure is based on Social Security Administration data on compensation

  8. Ever retired after randomization (all study participants)

    Time frame: From initial randomization (occurred between 2001-2004) through 2018

    This measure is based on Social Security Administration data on retirement entitlement/election

  9. Ever worked past minimum retirement age (partial benefits, age 62; excluding unemployed study participants)

    Time frame: From initial randomization (occurred between 2001-2004) through 2018

    This measure is based on Social Security Administration data on earnings

  10. Ever worked past minimum retirement age (full benefits, age 65 or 66 depending on date of birth; excluding unemployed study participants)

    Time frame: From initial randomization (occurred between 2001-2004) through 2018

    This measure is based on Social Security Administration data on earnings

  11. Total compensation (from employment, self-employment, pensions, and distributions from retirement accounts) after randomization (all study participants)

    Time frame: From initial randomization (occurred between 2001-2004) through 2018

    This measure is based on Social Security Administration data on compensation

  12. Ever employed (any earnings from employment and/or self-employment) during first 10 years after randomization (all study participants)

    Time frame: From initial randomization (occurred between 2001-2004) through 2014

    This measure is based on Social Security Administration data on earnings

  13. Total person-years employed (any earnings from employment and/or self-employment) during first 10 years after randomization (all study participants)

    Time frame: From initial randomization (occurred between 2001-2004) through 2014

    This measure is based on Social Security Administration data on earnings

  14. Total earnings (from employment and/or self-employment) during first 10 years after randomization (all study participants)

    Time frame: From initial randomization (occurred between 2001-2004) through 2014

    This measure is based on Social Security Administration data on earnings

  15. Total compensation (from employment, self-employment, pensions, and distributions from retirement accounts) during first 10 years after randomization (all study participants)

    Time frame: From initial randomization (occurred between 2001-2004) through 2014

    This measure is based on Social Security Administration data on compensation

  16. Ever retired during first 10 years after randomization (all study participants)

    Time frame: From initial randomization (occurred between 2001-2004) through 2014

    This measure is based on Social Security Administration data on retirement entitlement/election

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • University of Southern California
  • Wake Forest University

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2022
Study completion
2023
First posted
Sep 24, 2020
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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