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

• Sponsor: University of Minnesota (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04563598
• Collaborator: University of Southern California (Other), Wake Forest University (Other), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
• Enrollment: 3,093
• Anticipated Duration (Months): 66.3

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	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 Design

• Study Type: Observational
• Actual Enrollment: 3093 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: The Effects of an Intensive Lifestyle Intervention for Type 2 Diabetes on Employment, Earnings, and Retirement
• Actual Study Start Date: Dec 19, 2016
• Anticipated Primary Completion Date: Jun 30, 2022
• Anticipated Study Completion Date: Jun 30, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

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

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

1. Number of employers (unique employer IDs) per study year (excluding unemployed study participants) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [From initial randomization (occurred between 2001-2004) through 2014]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

(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:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Peter J Huckfeldt, PhD, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT04563598
• Other Study ID Numbers: UP-16-00706-3; 5R01DK107552
• First Posted: Sep 24, 2020
• Last Update Posted: Aug 26, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Aug 26, 2021