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

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Behavioral: Intensive lifestyle intervention (ILI); Behavioral: Diabetes support and education (DSE)

• Registration Number: NCT04563598
• Lead Sponsor: University of Minnesota

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2016-12-19
• Study First Submitted: 2020-09-18
• Study First Submitted QC: 2020-09-18
• Study First Posted: 2020-09-24
• Primary Completion: 2022-06-30
• Study Completion: 2023-06-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3091

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

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Exclusion Criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ILI/ Treatment group	Intensive lifestyle intervention (ILI)	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.
DSE/Control group	Diabetes support and education (DSE)	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.

Primary Outcome Measures

Name	Time	Method
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
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

Name	Time	Method
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
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.
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
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
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
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
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