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

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).

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: Intensive lifestyle intervention (ILI); Behavioral: Diabetes support and education (DSE)

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.

• Study Type: Observational
• Enrollment (Actual): 3091

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

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 Social Security Administration databases
• Were successfully linked to Social Security Administration data

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 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 Social Security Administration databases.	Behavioral: Diabetes support and education (DSE); Behavioral intervention focused on diabetes support and education

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University of Southern California; Wake Forest University
• Investigators: Principal Investigator: Peter J Huckfeldt, PhD, University of Minnesota

Publications and helpful links

General 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. Erratum In: N Engl J Med. 2014 May 8;370(19):1866.

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2016
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: September 18, 2020
• First Submitted That Met QC Criteria: September 18, 2020
• First Posted (Actual): September 24, 2020

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: UP-16-00706-3; 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 University.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No