The Long-term Effects of an Intensive Lifestyle Intervention for Type 2 Diabetes on Medicare Outcomes
1 other identifier
observational
2,796
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2016
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 19, 2016
CompletedFirst Submitted
Initial submission to the registry
December 13, 2018
CompletedFirst Posted
Study publicly available on registry
May 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedSeptember 30, 2022
September 1, 2022
5.5 years
December 13, 2018
September 29, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (8)
Total Medicare spending
12-years
Medicare inpatient payments
12-years
Medicare Part D drug payments
12-years
Medicare Part D drug costs
12-years
Medicare outpatient visits
12-years
- +3 more secondary outcomes
Other Outcomes (11)
Originally eligible for Medicare through Old Age and Survivor's Insurance
12-years
Originally eligible for Medicare through Disability Insurance Benefits
12-years
Originally eligible for Medicare due to End Stage Renal Disease (ESRD)
12-years
- +8 more other outcomes
Study Arms (2)
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.
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.
Interventions
Lifestyle intervention focused on weight loss through diet and physical activity
Behavioral intervention focused on diabetes support and education
Eligibility Criteria
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.
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Minnesotalead
- University of Southern Californiacollaborator
- Wake Forest Universitycollaborator
Related Publications (2)
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.
PMID: 23796131BACKGROUNDHuckfeldt 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.
PMID: 33231638RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter J Huckfeldt, PhD
University of Minnesota
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2018
First Posted
May 16, 2019
Study Start
December 19, 2016
Primary Completion
June 30, 2022
Study Completion
June 30, 2022
Last Updated
September 30, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share
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.