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

The Long-term Effects of an Intensive Lifestyle Intervention for Type 2 Diabetes on Medicare Eligibility, Health Care Use, and Health Care Spending

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.

Study Overview

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

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.

• Study Type: Observational
• Enrollment (Actual): 2796

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population includes Look AHEAD participants that consented to administrative data linkages, provided individual identifiers that could be linked with Medicare data, and were successfully linked to Medicare data.

Description

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:

-

Study Plan

How is the study designed?

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, consented to administrative data linkages, and were successfully linked to Medicare databases.	Behavioral: Intensive lifestyle intervention; 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.	Behavioral: Diabetes support and education; Behavioral intervention focused on diabetes support and education

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total inpatient (general hospital/acute care) discharges	This is based on patient-level HEDIS specifications.	12-years
Total inpatient (general hospital/acute care) days	This is based on patient-level HEDIS specifications.	12-years
Total number of emergency department visits	This is based on patient-level HEDIS specifications.	12-years
Medicare Part D Prescription Drug Fill Count	Derived measure indicating number of 30-day supply equivalents in each year.	12-years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Medicare spending	Sums Medicare payments across service use categories	12-years
Medicare inpatient payments	Patient-level inpatient payments	12-years
Medicare Part D drug payments	Part D plan payments for covered drugs in a given year	12-years
Medicare Part D drug costs	Gross drug costs for all Part D drugs for a given year	12-years
Medicare outpatient visits	Based on patient-level HEDIS specifications	12-years
Medicare hospital outpatient payments	Based on Medicare records	12-years
Medicare Part B physician payments	Based on Medicare records	12-years
Medicare Skilled Nursing Facility payments	Based on Medicare records	12-years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Originally eligible for Medicare through Old Age and Survivor's Insurance	This is based on "Original Reason for Entitlement" field in Medicare Beneficiary Summary File	12-years
Originally eligible for Medicare through Disability Insurance Benefits	This is based on "Original Reason for Entitlement" field in Medicare Beneficiary Summary File	12-years
Originally eligible for Medicare due to End Stage Renal Disease (ESRD)	This is based on "Original Reason for Entitlement" field in Medicare Beneficiary Summary File	12-years
Hospital readmissions	Based on HEDIS specifications	12-years
Inpatient medicine discharges	Based on patient-level HEDIS specifications	12-years
Inpatient surgical discharges	Based on patient-level HEDIS specifications	12-years
Inpatient medicine days	Based on patient-level HEDIS specifications	12-years
Inpatient surgical days	Based on patient-level HEDIS specifications	12-years
Medicare Dialysis Payments	Based on Medicare records	12-years
Medicare Durable Medical Equipment payments	Based on Medicare records	12-years
Medicare Imaging + Test payments	Based on Medicare records	12-years

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: 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.
• 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.

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: December 13, 2018
• First Submitted That Met QC Criteria: May 14, 2019
• First Posted (Actual): May 16, 2019

Study Record Updates

• Last Update Posted (Actual): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 29, 2022
• Last Verified: September 1, 2022

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

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Use of Medicare data is restricted under a data use agreement between the Centers of Medicare and Medicaid Services and University of Southern California, Wake Forest, and the University of Minnesota.

Drug and device information, study documents

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