The Long-term Effects of an Intensive Lifestyle Intervention for Type 2 Diabetes on Medicare Outcomes

NCT ID: NCT03952728

Last Updated: 2022-09-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2796 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-12-19
• Study Completion Date: 2022-06-30

Brief Summary

This study investigates whether an intensive lifestyle intervention for type 2 diabetes had long-term effects on Medicare enrollment, health care use, and health care spending.

Detailed Description

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. In addition, the ILI led to reductions in hospitalizations, hospital days, and prescription drug spending during the intervention period (through 2012). However, the longer-term effects (2012 and later) on health care use and spending remain unknown.

In an ongoing ancillary study, the researchers are investigating the effects of the ILI on economic outcomes, during and after the study. As a part of this study, the study team is linking consenting Look AHEAD participants to Medicare databases. The researchers will investigate the long-term effects of ILI on health care use and health care spending.

By 2012 nearly all Look AHEAD participants were eligible for Medicare due to age (over 65). To the extent that Look AHEAD participants developed severe disabilities, the participants may have gained Medicare eligibility earlier through enrollment in Social Security Disability Insurance (SSDI). Thus, the researchers will also test for differences in the Medicare enrollment channel between ILI and control group participants, specifically whether the groups enrolled through SSDI at different rates.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

ILI/ Treatment group

This group includes Look AHEAD participants who were initially assigned to the intensive lifestyle intervention, consented to administrative data linkages, and were successfully linked to Medicare databases.

Intensive lifestyle intervention

Intervention Type: BEHAVIORAL

Lifestyle intervention focused on weight loss through diet and physical activity

Control group

This group includes Look AHEAD participants who were initially assigned to the diabetes support and education control arm, consented to administrative data linkages, and were successfully linked to Medicare databases.

Diabetes support and education

Intervention Type: BEHAVIORAL

Behavioral intervention focused on diabetes support and education

Interventions

Intensive lifestyle intervention

Lifestyle intervention focused on weight loss through diet and physical activity

Intervention Type: BEHAVIORAL

Diabetes support and education

Behavioral intervention focused on diabetes support and education

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Look AHEAD participation: met age requirements and other criteria at time of study enrollment (as noted in Look AHEAD Research Group (2013))
• Consented to administrative data linkages
• Provided individual identifiers that could be linked with Medicare databases
• Were successfully linked to Medicare data

Exclusion Criteria

-

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern California

OTHER

Sponsor Role: collaborator

Wake Forest University

OTHER

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter J Huckfeldt, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

References

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.

Reference Type: BACKGROUND

PMID: 23796131 (View on PubMed)

Huckfeldt PJ, Frenier C, Pajewski NM, Espeland M, Peters A, Casanova R, Pi-Sunyer X, Cheskin L, Goldman DP. Associations of Intensive Lifestyle Intervention in Type 2 Diabetes With Health Care Use, Spending, and Disability: An Ancillary Study of the Look AHEAD Study. JAMA Netw Open. 2020 Nov 2;3(11):e2025488. doi: 10.1001/jamanetworkopen.2020.25488.

Reference Type: RESULT

PMID: 33231638 (View on PubMed)

Other Identifiers

UP-16-00706

Identifier Type: -

Identifier Source: org_study_id