Clinical trial NCT01050205: Diabetes Prevention Translation: the Healthy Lifestyle Project
Official title: Diabetes Prevention Translation Project: the Healthy Lifestyle Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Cardiovascular Risk Factor
Keywords: Diabetes Prevention
Cardiovascular Risk Reduction
Lifestyle Intervention
Group Lifestyle Balance
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2010-01-15
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Evidence that lifestyle intervention can prevent or delay the development of type 2 diabetes has been demonstrated in several clinical trials including a multi center clinical trial in the US, the Diabetes Prevention Program (DPP). The challenge for public health is to translate this promising and proven behavioral intervention utilized in the DPP research effort to the "real world", i.e., how to make it work in diverse communities in a variety of local settings at a reduced cost so that the maximal number of those at risk can benefit.

The purpose of this application is to test a framework for translation of the DPP that includes: 1) demonstration of a training model for community health care professionals that includes initial training, support, and supervision in the delivery of a diabetes prevention curriculum and the needed behavioral lifestyle materials both initially and over time; 2) evaluation of a more compact and flexible DPP intervention program administered to each participant in a version of his or her choice (standard face-to-face group format or a DVD version of the same lifestyle intervention program content). These lifestyle intervention programs will be carried out in three different community settings; i.e. a health care practice, a worksite, and local centers in the community dedicated to healthy aging for older adults. Lastly, the cost-effectiveness analyses of the GLB intervention program in each of the three community settings will be tested.

Eligibility criteria: Inclusion Criteria:

* 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:

  1. Waist circumference (\>40 inches men, \>35 inches women);
  2. Blood pressure \>130 mmHg (systolic) or \>85 mmHg (diastolic) OR history of diagnosed hypertension
  3. Low HDL level (\<40mg/dL men, \<50 mg/dL women)
  4. Elevated triglyceride level \>150 mg/dL
  5. Fasting glucose \>100mg/dL and \<126mg/dL All individuals enrolled in the study should have at least 6th grade reading/writing ability.

Exclusion Criteria:

* Screening Exclusionary Criteria: Women who are currently (or within past 6-weeks) pregnant or lactating, or any individual planning to leave the area before the end of the effort will be considered ineligible to participate in the screening.
* Intervention Exclusionary Criteria: Exclusionary criterion for intervention is the same as for screening. In addition, individuals who are on metformin or are identified as having diabetes as a result of the screening are not eligible. Individuals who have recently (within the past 3 months) initiated or changed their dosage of any blood pressure or lipid medication will also be excluded as being on an unstable regimen will complicate the interpretation of any blood pressure or lipid effects of the intervention.

Primary outcomes:
measure: Changes in Weight Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.
timeFrame: Baseline and post-intervention (assessed at 6 months after commencement of intervention)
Secondary outcomes:
measure: Changes in Fasting Glucose Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.
timeFrame: Baseline and post-intervention (assessed at 6 months after commencement of intervention)
measure: Changes in Fasting Insulin Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.
timeFrame: Baseline and post-intervention (assessed at 6 months after commencement of intervention)
measure: Changes in Fasting Lipids (Total Cholesterol) Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.
timeFrame: Baseline and post-intervention (assessed at 6 months after commencement of intervention)
measure: Changes in Fasting Lipids (Triglycerides) Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.
timeFrame: Baseline and post-intervention (assessed at 6 months after commencement of intervention)
measure: Changes in Fasting Lipids (HDL Cholesterol) Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.
timeFrame: Baseline and post-intervention (assessed at 6 months after commencement of intervention)
measure: Changes in Fasting Lipids (LDL Cholesterol) Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.
timeFrame: Baseline and post-intervention (assessed at 6 months after commencement of intervention)
measure: Changes in A1c Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.
timeFrame: Baseline and post-intervention (assessed at 6 months after commencement of intervention)
measure: Changes in Systolic Blood Pressure (BP) Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.
timeFrame: Baseline and post-intervention (assessed at 6 months after commencement of intervention)
measure: Changes in Waist Circumference Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.
timeFrame: Baseline and post-intervention (assessed at 6 months after commencement of intervention)
measure: Changes in Self-reported Physical Activity Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.
timeFrame: Baseline and post-intervention (assessed at 6 months after commencement of intervention)
measure: Changes in Diastolic Blood Pressure (BP) Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.
timeFrame: Baseline and post-intervention (assessed at 6 months after commencement of intervention)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Andrea M Kriska, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Devaraj 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.
citation: Rockette-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.
citation: Schafer 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.
citation: Kramer 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.
citation: Eaglehouse 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.
citation: Eaglehouse 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.
citation: Vanderwood 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.