Clinical trial NCT00631345: Healthy Living Partnership to Prevent Diabetes
Official title: Translating Research Into the Prevention of Diabetes Mellitus (TRIP DM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetes
Obesity
Keywords: prediabetes
overweight
obesity
metabolic syndrome
community health worker
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2008-03-07
Enrollment: 301
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The Healthy Living Partnership to Prevent Diabetes (HELP PD) is a 300-participant randomized trial designed to test the effectiveness of a lay-health counselor led community-based diabetes prevention program in reducing blood glucose in people at risk for developing diabetes mellitus.

Detailed description: Social forces have promoted adverse behavioral patterns with respect to physical activity and nutrition resulting in the current epidemics of obesity, the metabolic syndrome and type 2 diabetes mellitus (DM). Results from clinical trials such as the Diabetes Prevention Program (DPP) have demonstrated a significant potential for prevention of type 2 DM through lifestyle interventions to promote physical activity, a healthy eating pattern and weight loss. Yet these approaches are not being applied in practice. In fact, whether these approaches can be successfully implemented in the community is an unanswered question. The Healthy Living Partnership to Prevent Diabetes (HELP PD) was designed to address this knowledge gap in a community setting. It incorporates key translations of prior research to enhance logistical and fiscal feasibility and long term dissemination, including the use of a group-based, rather than an individual-based, intensive lifestyle behavioral intervention employing professionals and community health workers (CHWs), and delivery of the intervention in the community setting via expansion of an existing Diabetes Education Program (DEP). The trial has been continued for an additional 5 years, and the primary goal of the continuation is to test the long-term glucose lowering effects of the HELP PD intervention by randomizing the lifestyle group to continued group maintenance or a self-directed maintenance condition and to follow the UC group for additional comparison purposes. Demonstrating the longer term effectiveness of HELP PD will represent a key step in establishing the value of this approach to translation of DM prevention into the community. This crucial evidence will be used to support reimbursement policy for DM prevention, dissemination of the HELP PD CHW approach and generalization to other behaviorally influenced chronic diseases.

Eligibility criteria: Inclusion Criteria:

* Able to read/understand English at or above a level sufficient to comprehend recruitment and intervention materials
* BMI greater than or equal to 25 kg/m2 but less than 40 kg/m2
* Fasting blood glucose 95-125 mg/dl (inclusive)
* Willingness to Accept Randomization

Exclusion Criteria:

* Currently involved in a supervised program for weight loss
* Clinical history of DM, or newly diagnosed DM at screening
* Clinical history of cardiovascular disease (CVD) occurring within the past 6 months, including myocardial infarction, angina, coronary revascularization, stroke, TIA, carotid revascularization, peripheral arterial disease, and congestive heart failure
* Uncontrolled high blood pressure: BP \> 160/100
* Pregnancy, breast feeding, or planning pregnancy within 2 years
* Other chronic disease likely to limit lifespan to less than 2-3 years, including any cancer requiring treatment in past 5 years except non-melanoma skin cancer
* Chronic use of medicine known to significantly affect glucose metabolism, e.g., corticosteroids
* Conditions/criteria likely to interfere with participation and acceptance of randomized assignment, including the following: inability/unwillingness to give informed consent, another household member already randomized to HELP PD, major psychiatric or cognitive problems (schizophrenia, dementia, self-reported active illegal substance or alcohol abuse), and participation in another research study that would interfere with HELP PD

Primary outcomes:
measure: Fasting Glucose
timeFrame: Change from Baseline at 6, 12, 18, 24, 36, 42, 48, 54, 60, 66, 72 and 78 months from randomization
Secondary outcomes:
measure: Weight Loss
timeFrame: Change from Baseline at 6, 12, 18, 24, 36, 42, 48, 54, 60, 66, 72 and 78 months from randomization
measure: Waist Circumference
timeFrame: Change from Baseline at 6, 12, 24, 36, 48, 60, and 72 months from randomization
measure: Dietary Intake
timeFrame: Change from Baseline at 6, 12, 24, 36, 48, 60, and 72 months from randomization
measure: Physical Activity
timeFrame: Change from Baseline at 6, 12, 24, 36, 48, 60, and 72 months from randomization
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Mara Z Vitolins, DrPH MPH RDN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Katula JA, Vitolins MZ, Rosenberger EL, Blackwell C, Espeland MA, Lawlor MS, Rejeski WJ, Goff DC. Healthy Living Partnerships to Prevent Diabetes (HELP PD): design and methods. Contemp Clin Trials. 2010 Jan;31(1):71-81. doi: 10.1016/j.cct.2009.09.002. Epub 2009 Sep 13.
citation: Blackwell CS, Foster KA, Isom S, Katula JA, Vitolins MZ, Rosenberger EL, Goff DC Jr. Healthy Living Partnerships to Prevent Diabetes: recruitment and baseline characteristics. Contemp Clin Trials. 2011 Jan;32(1):40-9. doi: 10.1016/j.cct.2010.10.006. Epub 2010 Oct 23.
citation: Katula JA, Blackwell CS, Rosenberger EL, Goff DC Jr; Healthy Living Partnerships to Prevent Diabetes Research Team. Translating diabetes prevention programs: implications for dissemination and policy. N C Med J. 2011 Sep-Oct;72(5):405-8.
citation: Rosenberger Hale E, Goff DC, Isom S, Blackwell C, Whitt-Glover MC, Katula JA. Relationship of weekly activity minutes to metabolic syndrome in prediabetes: the healthy living partnerships to prevent diabetes. J Phys Act Health. 2013 Jul;10(5):690-8. doi: 10.1123/jpah.10.5.690. Epub 2012 Oct 4.
citation: Katula JA, Vitolins MZ, Rosenberger EL, Blackwell CS, Morgan TM, Lawlor MS, Goff DC Jr. One-year results of a community-based translation of the Diabetes Prevention Program: Healthy-Living Partnerships to Prevent Diabetes (HELP PD) Project. Diabetes Care. 2011 Jul;34(7):1451-7. doi: 10.2337/dc10-2115. Epub 2011 May 18.
citation: Katula JA, Vitolins MZ, Morgan TM, Lawlor MS, Blackwell CS, Isom SP, Pedley CF, Goff DC Jr. The Healthy Living Partnerships to Prevent Diabetes study: 2-year outcomes of a randomized controlled trial. Am J Prev Med. 2013 Apr;44(4 Suppl 4):S324-32. doi: 10.1016/j.amepre.2012.12.015.
citation: Lawlor MS, Blackwell CS, Isom SP, Katula JA, Vitolins MZ, Morgan TM, Goff DC Jr. Cost of a group translation of the Diabetes Prevention Program: Healthy Living Partnerships to Prevent Diabetes. Am J Prev Med. 2013 Apr;44(4 Suppl 4):S381-9. doi: 10.1016/j.amepre.2012.12.016.
citation: Bishop J, Irby MB, Isom S, Blackwell CS, Vitolins MZ, Skelton JA. Diabetes prevention, weight loss, and social support: program participants' perceived influence on the health behaviors of their social support system. Fam Community Health. 2013 Apr-Jun;36(2):158-71. doi: 10.1097/FCH.0b013e318282b2d3.
citation: Beavers KM, Case LD, Blackwell CS, Katula JA, Goff DC Jr, Vitolins MZ. Effects of weight regain following intentional weight loss on glucoregulatory function in overweight and obese adults with pre-diabetes. Obes Res Clin Pract. 2015 May-Jun;9(3):266-73. doi: 10.1016/j.orcp.2014.09.003. Epub 2014 Oct 5.
citation: Miller GD, Isom S, Morgan TM, Vitolins MZ, Blackwell C, Brosnihan KB, Diz DI, Katula J, Goff D. Effects of a community-based weight loss intervention on adipose tissue circulating factors. Diabetes Metab Syndr. 2014 Oct-Dec;8(4):205-11. doi: 10.1016/j.dsx.2014.09.003. Epub 2014 Oct 5.
citation: Pedley CF, Case LD, Blackwell CS, Katula JA, Vitolins MZ. The 24-month metabolic benefits of the healthy living partnerships to prevent diabetes: A community-based translational study. Diabetes Metab Syndr. 2018 May;12(3):215-220. doi: 10.1016/j.dsx.2017.09.011. Epub 2017 Sep 23.
citation: Vitolins MZ, Isom SP, Blackwell CS, Kernodle D, Sydell JM, Pedley CF, Katula JA, Case LD, Goff DC Jr. The healthy living partnerships to prevent diabetes and the diabetes prevention program: a comparison of year 1 and 2 intervention results. Transl Behav Med. 2017 Jun;7(2):371-378. doi: 10.1007/s13142-016-0447-z.
citation: Vitolins MZ, Blackwell CS, Katula JA, Isom SP, Case LD. Long-term Weight Loss Maintenance in the Continuation of a Randomized Diabetes Prevention Translational Study: The Healthy Living Partnerships to Prevent Diabetes (HELP PD) Continuation Trial. Diabetes Care. 2019 Sep;42(9):1653-1660. doi: 10.2337/dc19-0295. Epub 2019 Jul 11.