Clinical trial NCT04563598: The Effects of an Intensive Lifestyle Intervention on Employment, Earnings, and Retirement
Official title: The Effects of an Intensive Lifestyle Intervention for Type 2 Diabetes on Employment, Earnings, and Retirement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: University of Southern California
name: Wake Forest University
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-09-24
Enrollment: 3091
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes Look AHEAD participants who consented to administrative data linkages, provided individual identifiers that could be linked with Social Security Administration data, and were successfully linked to Social Security Administration data.

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.

Eligibility 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:

-

Primary outcomes:
measure: Employed (any earnings from employment or self-employment) by study year (all study participants)
timeFrame: 12-month intervals relative to randomization occurring between 2001-2018
measure: Total earnings from employment and/or self-employment by study year (all study participants)
timeFrame: 12-month intervals relative to randomization occurring between 2001-2018
Secondary outcomes:
measure: Retired (any Social Security retirement entitlement/election) by study year (all study participants)
timeFrame: 12-month intervals relative to randomization occurring between 2001-2018
measure: Total earnings from employment and/or self-employment by study year (excluding unemployed study participants)
timeFrame: 12-month intervals relative to randomization occurring between 2001-2018
measure: Total person-years from randomization to retirement (all study participants)
timeFrame: From initial randomization (occurred between 2001-2004) through 2018
measure: Total person-years employed since randomization (all study participants)
timeFrame: From initial randomization (occurred between 2001-2004) through 2018
measure: Ever employed (any earnings from employment or self-employment) after randomization (all study participants)
timeFrame: From initial randomization (occurred between 2001-2004) through 2018
measure: Total earnings from employment and/or self-employment since randomization (all study participants)
timeFrame: From initial randomization (occurred between 2001-2004) through 2018
measure: Ever received Supplemental Security Income (SSI) benefits at age 65 since randomization (all study participants)
timeFrame: From initial randomization (occurred between 2001-2004) through 2018
Other outcomes:
measure: Number of employers (unique employer IDs) per study year (excluding unemployed study participants)
timeFrame: 12-month intervals relative to randomization occurring between 2001-2018
measure: Started a new job (new employer ID) by study year (all study participants)
timeFrame: 12-month intervals relative to randomization occurring between 2001-2018
measure: Started a new job (new employer ID) by study year (excluding unemployed study participants)
timeFrame: 12-month intervals relative to randomization occurring between 2001-2018
measure: Received any Supplemental Security Income (SSI) benefits at age 65 since randomization (all study participants)
timeFrame: 12-month intervals relative to randomization occurring between 2001-2018
measure: Received any self-employment income by study year (all study participants)
timeFrame: 12-month intervals relative to randomization occurring between 2001-2018
measure: Received any income from pensions or distributions from retirement accounts by study year (all study participants)
timeFrame: 12-month intervals relative to randomization occurring between 2001-2018
measure: Total compensation (from employment, self-employment, pensions, and distributions from retirement accounts (all study participants)
timeFrame: 12-month intervals relative to randomization occurring between 2001-2018
measure: Ever retired after randomization (all study participants)
timeFrame: From initial randomization (occurred between 2001-2004) through 2018
measure: Ever worked past minimum retirement age (partial benefits, age 62; excluding unemployed study participants)
timeFrame: From initial randomization (occurred between 2001-2004) through 2018
measure: Ever worked past minimum retirement age (full benefits, age 65 or 66 depending on date of birth; excluding unemployed study participants)
timeFrame: From initial randomization (occurred between 2001-2004) through 2018
measure: Total compensation (from employment, self-employment, pensions, and distributions from retirement accounts) after randomization (all study participants)
timeFrame: From initial randomization (occurred between 2001-2004) through 2018
measure: Ever employed (any earnings from employment and/or self-employment) during first 10 years after randomization (all study participants)
timeFrame: From initial randomization (occurred between 2001-2004) through 2014
measure: Total person-years employed (any earnings from employment and/or self-employment) during first 10 years after randomization (all study participants)
timeFrame: From initial randomization (occurred between 2001-2004) through 2014
measure: Total earnings (from employment and/or self-employment) during first 10 years after randomization (all study participants)
timeFrame: From initial randomization (occurred between 2001-2004) through 2014
measure: Total compensation (from employment, self-employment, pensions, and distributions from retirement accounts) during first 10 years after randomization (all study participants)
timeFrame: From initial randomization (occurred between 2001-2004) through 2014
measure: Ever retired during first 10 years after randomization (all study participants)
timeFrame: From initial randomization (occurred between 2001-2004) through 2014
Locations:
Study officials:
affiliation: University of Minnesota
name: Peter J Huckfeldt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.