NCT04515745

Brief Summary

Starting in 2001, the Look AHEAD study randomized patients with type 2 diabetes to an intensive lifestyle intervention (ILI) focused on weight loss versus a control group receiving diabetes education ("Diabetes Support and Education"). The ILI successfully reduced weight, improved diabetes control, and functional status, among other outcomes. In this study, the investigators will compare participation in federal disability insurance programs between the ILI and the control group during and after the intervention period (2001-2017).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,091

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 19, 2016

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 17, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

5.5 years

First QC Date

August 12, 2020

Last Update Submit

November 3, 2023

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (2)

  • Ever received public disability program benefits (Social Security Disability Insurance (SSDI) or disability-related Supplemental Security Income (SSI))

    This is based on Social Security Administration data on SSDI and SSI benefits, SSDI entitlement and SSI eligibility.

    This measure will capture program participation between randomization (randomization occurred between 2001-2004) through 2017

  • Ever applied for public disability program benefits (Social Security Disability Insurance (SSDI) or disability-related Supplemental Security Income (SSI))

    This is based on Social Security Administration data on applications for SSDI and SSI.

    From initial randomization (randomization occurred between 2001-2004) through 2017

Secondary Outcomes (16)

  • Ever received Social Security Disability Insurance (SSDI) benefits

    This measure will capture program participation occurring between randomization (occurred between 2001-2004) through 2017

  • Ever received disability-related Supplemental Security Income (SSI) benefits

    This measure will capture program participation occurring between randomization (occurred between 2001-2004) through 2017

  • Ever applied for Social Security Disability Insurance (SSDI) benefits

    From initial randomization (occurred between 2001-2004) through 2017

  • Ever applied for disability-related Supplemental Security Income (SSI) benefits

    From initial randomization (occurred between 2001-2004) through 2017

  • Total person-months of Social Security Disability Insurance (SSDI) benefits received

    From initial randomization (occurred between 2001-2004) through 2017

  • +11 more secondary outcomes

Other Outcomes (18)

  • Ever received disability benefits (Social Security Disability Insurance (SSDI) or disability-related Supplemental Security Income (SSI) benefits) within 8 years of randomization

    The first 8 years following randomization, which occurred from 2001 to 2004.

  • Ever received Social Security Disability Insurance (SSDI) benefits within 8 years of randomization

    This measure will capture program participation within 8 years of randomization (occurred 2001-2004)

  • Ever received disability-related Supplemental Security Income (SSI) benefits within 8 years of randomization

    This measure will capture program participation within 8 years of randomization (occurred 2001-2004)

  • +15 more other outcomes

Study Arms (2)

ILI/Treatment group

This group includes Look AHEAD participants who were initially assigned to the intensive lifestyle intervention (ILI), consented to administrative data linkages, and were successfully linked to Social Security Administration (SSA) databases.

Behavioral: Intensive lifestyle intervention (ILI)

DSE/Control group

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

Behavioral: Diabetes support and education (DSE)

Interventions

Intensive lifestyle intervention (ILI)BEHAVIORAL

Lifestyle intervention focused on weight loss through diet and physical activity

ILI/Treatment group
Diabetes support and education (DSE)BEHAVIORAL

Behavioral intervention focused on diabetes support and education

DSE/Control group

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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 SSA data, and were successfully linked to SSA data.

You may qualify if:

  • Look AHEAD participation: met age requirements and other criteria at time of study enrollment which occurred between 2001-2004 (as noted in Look AHEAD Research Group (2013))
  • Consented to administrative data linkages
  • Provided individual identifiers that could be linked with SSA databases
  • Were successfully linked to SSA data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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: 23796131BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Peter J Huckfeldt, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2020

First Posted

August 17, 2020

Study Start

December 19, 2016

Primary Completion

June 30, 2022

Study Completion

October 30, 2023

Last Updated

November 7, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Use of Social Security Administration data is restricted under a data use agreement between the Social Security Administration and Wake Forest.