Diabetes Prevention Translation: the Healthy Lifestyle Project
2 other identifiers
interventional
223
1 country
1
Brief Summary
The Diabetes Prevention Program (DPP), a large research study conducted in the United States, found that lifestyle intervention was effective in lowering risk for development of type 2 diabetes. It is important to evaluate the DPP lifestyle interventions in "real world" settings. The purpose of this project is to test an adapted version of the DPP lifestyle intervention in several community settings, including a worksite, a health care facility (primary care practice and local community centers dedicated to older adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes
Started Sep 2010
Longer than P75 for not_applicable diabetes
1 active site
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
First Submitted
Initial submission to the registry
January 13, 2010
CompletedFirst Posted
Study publicly available on registry
January 15, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedResults Posted
Study results publicly available
July 25, 2017
CompletedAugust 25, 2017
July 1, 2017
4.5 years
January 13, 2010
May 3, 2017
July 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in Weight Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.
Weight was measured twice using a digital physician's scale (DETECTO® PD100) placed on a hard, flat surface. Participants were asked to remove their shoes and stand in the middle of the scale with eyes straight forward and without touching any surface. The participant was asked to step down from the scale between measures. If the measures were more than 0.5 pounds apart, a third measure was taken. Weight is reported in pounds.
Baseline and post-intervention (assessed at 6 months after commencement of intervention)
Secondary Outcomes (11)
Changes in Fasting Glucose Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.
Baseline and post-intervention (assessed at 6 months after commencement of intervention)
Changes in Fasting Insulin Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.
Baseline and post-intervention (assessed at 6 months after commencement of intervention)
Changes in Fasting Lipids (Total Cholesterol) Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.
Baseline and post-intervention (assessed at 6 months after commencement of intervention)
Changes in Fasting Lipids (Triglycerides) Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.
Baseline and post-intervention (assessed at 6 months after commencement of intervention)
Changes in Fasting Lipids (HDL Cholesterol) Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.
Baseline and post-intervention (assessed at 6 months after commencement of intervention)
- +6 more secondary outcomes
Study Arms (2)
Current Intervention
ACTIVE COMPARATOREligible participants will be asked to choose Group Lifestyle Balance Group (GLB-Group) or Group Lifestyle Balance DVD (GLB-DVD). Upon choosing, participants will be randomly assigned to "Current intervention" Arm in which case they will receive the intervention immediately.
Delayed Intervention
ACTIVE COMPARATOREligible participants will be asked to choose Group Lifestyle Balance Group (GLB-Group) or Group Lifestyle Balance DVD (GLB-DVD). Upon choosing, participants will be randomly assigned to "Delayed Intervention" Arm in which case they will receive delayed intervention at 6 months.
Interventions
Participants assigned to Current Intervention will receive the intervention described below immediately after randomization. The one-year GLB program is an adaptation of the successful DPP lifestyle intervention. The goals of the intervention are to achieve and maintain a 7% weight loss, and to safely and progressively increase physical activity to 150 minutes per week of moderately intense physical activity. GLB-GROUP: group meetings weekly transitioning to monthly over one year led by a trained coach. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the GLB program. GLB-DVD participants complete the sessions via DVD and have telephonic contact with their coach as well as monthly group meetings.
Participants assigned to Delayed Intervention receive the same intervention as Current Intervention Group, 6 months from randomization. The one-year GLB program is an adaptation of the successful DPP lifestyle intervention. The goals of the intervention are to achieve and maintain a 7% weight loss, and to safely and progressively increase physical activity to 150 minutes per week of moderately intense physical activity. GLB-GROUP: group meetings weekly transitioning to monthly over one year led by a trained coach. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the GLB program. GLB-DVD participants complete the sessions via DVD and have telephonic contact with their coach as well as monthly group meetings.
Eligibility Criteria
You may qualify if:
- Screening Eligibility Criteria: Non-diabetic men and women from the specific study sites in the local area who are age 18 years and older at the time of screening with a BMI of at least 25 kg/m2 are eligible for screening.
- Intervention Eligibility Criteria: Individuals attending screening who are found to have prediabetes AND/OR metabolic syndrome are eligible to participate in the intervention. Pre-diabetes is defined as having a fasting glucose \>100 mg/dL and \<126mg/dL. Metabolic syndrome is defined as having at least 3 of the 5 following risk factors:
- Waist circumference (\>40 inches men, \>35 inches women);
- Blood pressure \>130 mmHg (systolic) or \>85 mmHg (diastolic) OR history of diagnosed hypertension
- Low HDL level (\<40mg/dL men, \<50 mg/dL women)
- Elevated triglyceride level \>150 mg/dL
- Fasting glucose \>100mg/dL and \<126mg/dL All individuals enrolled in the study should have at least 6th grade reading/writing ability.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (8)
Kramer MK, Agee SC, Miller RG, Arena VC, Vanderwood KK, Eaglehouse YL, Venditti EM, Kriska AM. Translating the Diabetes Prevention Program Lifestyle Intervention to the Military Setting. Mil Med. 2023 May 16;188(5-6):1036-1045. doi: 10.1093/milmed/usac037.
PMID: 35234887DERIVEDDevaraj SM, Napoleone JM, Miller RG, Rockette-Wagner B, Arena VC, Mitchell-Miland C, Saad MB, Kriska AM. The role of Sociodemographic factors on goal achievement in a community-based diabetes prevention program behavioral lifestyle intervention. BMC Public Health. 2021 Oct 2;21(1):1783. doi: 10.1186/s12889-021-11844-z.
PMID: 34600527DERIVEDRockette-Wagner B, Miller RG, Eaglehouse YL, Arena VC, Kramer MK, Kriska AM. Leisure Sedentary Behavior Levels and Meeting Program Goals in a Community Lifestyle Intervention for Diabetes Prevention. J Phys Act Health. 2021 Jan 1;18(1):44-51. doi: 10.1123/jpah.2020-0052. Epub 2020 Dec 22.
PMID: 33361473DERIVEDSchafer GL, Songer TJ, Arena VC, Kramer MK, Miller RG, Kriska AM. Participant food and activity costs in a translational Diabetes Prevention Program. Transl Behav Med. 2021 Mar 16;11(2):351-358. doi: 10.1093/tbm/ibaa031.
PMID: 32298445DERIVEDKramer MK, Vanderwood KK, Arena VC, Miller RG, Meehan R, Eaglehouse YL, Schafer G, Venditti EM, Kriska AM. Evaluation of a Diabetes Prevention Program Lifestyle Intervention in Older Adults: A Randomized Controlled Study in Three Senior/Community Centers of Varying Socioeconomic Status. Diabetes Educ. 2018 Apr;44(2):118-129. doi: 10.1177/0145721718759982. Epub 2018 Mar 7.
PMID: 29514568DERIVEDEaglehouse YL, Rockette-Wagner B, Kramer MK, Arena VC, Miller RG, Vanderwood KK, Kriska AM. Physical Activity Levels in a Community Lifestyle Intervention: A Randomized Trial. Transl J Am Coll Sports Med. 2016 Jun 1;1(5):45-51.
PMID: 27551690DERIVEDEaglehouse YL, Schafer GL, Arena VC, Kramer MK, Miller RG, Kriska AM. Impact of a community-based lifestyle intervention program on health-related quality of life. Qual Life Res. 2016 Aug;25(8):1903-12. doi: 10.1007/s11136-016-1240-7. Epub 2016 Feb 20.
PMID: 26896960DERIVEDVanderwood KK, Kramer MK, Miller RG, Arena VC, Kriska AM. Evaluation of non-invasive screening measures to identify individuals with prediabetes. Diabetes Res Clin Pract. 2015 Jan;107(1):194-201. doi: 10.1016/j.diabres.2014.06.003. Epub 2014 Jun 21.
PMID: 25441924DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Physical activity data was self-reported. Sample was predominantly white, female, which may not be representative of other groups.
Results Point of Contact
- Title
- Dr. Andrea Kriska
- Organization
- University of Pittsburgh
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea M Kriska, PhD
University of Pittsburgh
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
January 13, 2010
First Posted
January 15, 2010
Study Start
September 1, 2010
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
August 25, 2017
Results First Posted
July 25, 2017
Record last verified: 2017-07