Intensive lifestyle intervention
BehavioralLifestyle intervention focused on weight loss through diet and physical activity
NCT Number: NCT03952728
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.
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Notify Me45 year–75 year
All sexes
Observational
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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Lifestyle intervention focused on weight loss through diet and physical activity
Behavioral intervention focused on diabetes support and education
Time frame: 12-years
This is based on patient-level HEDIS specifications.
Time frame: 12-years
This is based on patient-level HEDIS specifications.
Time frame: 12-years
This is based on patient-level HEDIS specifications.
Time frame: 12-years
Derived measure indicating number of 30-day supply equivalents in each year.
Time frame: 12-years
Sums Medicare payments across service use categories
Time frame: 12-years
Patient-level inpatient payments
Time frame: 12-years
Part D plan payments for covered drugs in a given year
Time frame: 12-years
Gross drug costs for all Part D drugs for a given year
Time frame: 12-years
Based on patient-level HEDIS specifications
Time frame: 12-years
Based on Medicare records
Time frame: 12-years
Based on Medicare records
Time frame: 12-years
Based on Medicare records
Time frame: 12-years
This is based on "Original Reason for Entitlement" field in Medicare Beneficiary Summary File
Time frame: 12-years
This is based on "Original Reason for Entitlement" field in Medicare Beneficiary Summary File
Time frame: 12-years
This is based on "Original Reason for Entitlement" field in Medicare Beneficiary Summary File
Time frame: 12-years
Based on HEDIS specifications
Time frame: 12-years
Based on patient-level HEDIS specifications
Time frame: 12-years
Based on patient-level HEDIS specifications
Time frame: 12-years
Based on patient-level HEDIS specifications
Time frame: 12-years
Based on patient-level HEDIS specifications
Time frame: 12-years
Based on Medicare records
Time frame: 12-years
Based on Medicare records
Time frame: 12-years
Based on Medicare records
University of Minnesota
Other
The Long-term Effects of an Intensive Lifestyle Intervention for Type 2 Diabetes on Medicare Eligibility, Health Care Use, and Health Care Spending
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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