Type 2 Diabetes MellitusNCT03952728
The Long-term Effects of an Intensive Lifestyle Intervention for Type 2 Diabetes on Medicare Outcomes
An observational study of Type 2 Diabetes Mellitus, run by University of Minnesota.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Intensive lifestyle intervention and Diabetes support and education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,796 participants
- Where
- No sites listed yet
- Study dates
- 19 Dec 2016to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- -
About this study
Official title: 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.
Read the 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
- Being tested
- Intensive lifestyle intervention, Diabetes support and education
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive lifestyle interventionBehavioural
Lifestyle intervention focused on weight loss through diet and physical activity
Diabetes support and educationBehavioural
Behavioral intervention focused on diabetes support and education
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Intensive lifestyle intervention | |
| 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. Receives: Behavioral: Diabetes support and education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total inpatient (general hospital/acute care) discharges
This is based on patient-level HEDIS specifications.
Measured: 12-years
Total inpatient (general hospital/acute care) days
This is based on patient-level HEDIS specifications.
Measured: 12-years
Total number of emergency department visits
This is based on patient-level HEDIS specifications.
Measured: 12-years
Medicare Part D Prescription Drug Fill Count
Derived measure indicating number of 30-day supply equivalents in each year.
Measured: 12-years
Secondary outcomes (8)
Total Medicare spending
Sums Medicare payments across service use categories
Measured: 12-years
Medicare inpatient payments
Patient-level inpatient payments
Measured: 12-years
Medicare Part D drug payments
Part D plan payments for covered drugs in a given year
Measured: 12-years
Medicare Part D drug costs
Gross drug costs for all Part D drugs for a given year
Measured: 12-years
Medicare outpatient visits
Based on patient-level HEDIS specifications
Measured: 12-years
Medicare hospital outpatient payments
Based on Medicare records
Measured: 12-years
Medicare Part B physician payments
Based on Medicare records
Measured: 12-years
Medicare Skilled Nursing Facility payments
Based on Medicare records
Measured: 12-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start19 Dec 2016
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,796 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern California, Wake Forest University
- Responsible party
- Sponsor
- Investigators
- Peter J Huckfeldt, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03952728
- Sponsor's protocol ID
- UP-16-00706
- Status last verified
- Sep 2022
- First submitted
- 13 Dec 2018
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 23796131Huckfeldt 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.
PubMed 33231638
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long-term Effects of an Intensive Lifestyle Intervention for Type 2 Diabetes on Medicare Eligibility, Health Care Use, and Health Care Spending
- ClinicalTrials.gov ID
- NCT03952728
- Acronym / sponsor ID
- UP-16-00706
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,796 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- University of Southern California, Wake Forest University
- Study start
- 19 Dec 2016 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 16 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ILI/ Treatment group | – | Behavioral: Intensive lifestyle interventionThis 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 | – | Behavioral: Diabetes support and educationThis 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. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive lifestyle interventionLifestyle intervention focused on weight loss through diet and physical activity | Behavioural | ILI/ Treatment group |
| Diabetes support and educationBehavioral intervention focused on diabetes support and education | Behavioural | Control group |
Primary outcome
Total inpatient (general hospital/acute care) discharges
Time frame: 12-years
This is based on patient-level HEDIS specifications.
Total inpatient (general hospital/acute care) days
Time frame: 12-years
This is based on patient-level HEDIS specifications.
Total number of emergency department visits
Time frame: 12-years
This is based on patient-level HEDIS specifications.
Medicare Part D Prescription Drug Fill Count
Time frame: 12-years
Derived measure indicating number of 30-day supply equivalents in each year.
8 secondary outcomes
Total Medicare spending
Time frame: 12-years
Medicare inpatient payments
Time frame: 12-years
Medicare Part D drug payments
Time frame: 12-years
Medicare Part D drug costs
Time frame: 12-years
Medicare outpatient visits
Time frame: 12-years
Medicare hospital outpatient payments
Time frame: 12-years
Medicare Part B physician payments
Time frame: 12-years
Medicare Skilled Nursing Facility payments
Time frame: 12-years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- Background: PubMed 23796131Look 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.
- Results publication: PubMed 33231638Huckfeldt 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter J Huckfeldt, PhD principal investigator
University of Minnesota
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus, run by University of Minnesota.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total inpatient (general hospital/acute care) discharges (time frame: 12-years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03952728, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2022.