An interventional study of Clinical referral to diabetes prevention lifestyle and Clinical referral to group diabetes prevention lifestyle in Pre-diabetic State, Overweight and Obesity, sponsored by Northwestern University. Completed at 2 sites in United States. Open to participants aged 25 Years and older. Per ClinicalTrials.gov, last updated 2016-12-01.
Sponsored by Northwestern University · Not applicable, Interventional, and Prevention
The Diabetes Prevention Program (DPP) demonstrated that an intensive lifestyle intervention resulting in modest weight loss and increased physical activity can delay or prevent the development of type 2 diabetes in those at increase risk for the disease. The lifestyle program used, however, was not designed for delivery on a public health scale. Successful DPP translation will require a sustainable partnership between a health care system and an established community organization committed to community health and experienced in implementing sustainable health and wellness programs. We have been collaborating with local health system and community administrators for over a year to design a 'real-world' clinic-based screening model to identify and refer high-risk patients for a group-based adaptation of the DPP lifestyle intervention in community facilities. We have designed this study to develop preliminary data about the feasibility and yield of clinic-based screening and referral, as well as the effectiveness of the adapted lifestyle intervention. This pilot study seeks to: 1) evaluate the feasibility of a strategy to implement American Diabetes Association (ADA) recommendations for clinic-based diabetes-risk testing and to refer high-risk patients for a community-based lifestyle intervention; 2) compare two strategies to enhance community-based program participation by referred patients; 3) demonstrate the capability of community facilities to schedule and enroll referred clinic patients at high-risk for diabetes and to deliver a modified, group-based DPP lifestyle intervention consistently; and 4) compare levels of weight loss and physical activity achieved by referred clinic patients with pre-diabetes who participate in a free-of-charge, group-based DPP lifestyle intervention at community facilities compared to a free-of-charge, traditional, one-on-one DPP lifestyle intervention at a DPP research site. Addressing these issues now will enable us to evaluate this partnered DPP translation model with a larger, more robust future study that will involve referral by multiple primary care clinics, program delivery at more community sites, and a 3-year follow-up period.
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Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
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25 years of age or older Body-mass index of >= 24 kg/m2
or more additional risk factors if age is \<45
Exclusion Criteria:
Diseases that could limit lifespan or increase risk with a lifestyle intervention - Cancer diagnosed in the past 5 years
Exclusions related to metabolism - Past anti-diabetes medication use, except during gestational diabetes
Exclusions for conditions / behaviors likely to affect study conduct
Clinical referral to diabetes prevention lifestyle intervention at School of Medicine campus
Behavioral: Clinical referral to diabetes prevention lifestyle
Clinical referral to group diabetes prevention lifestyle intervention program in community
Behavioral: Clinical referral to group diabetes prevention lifestyle
16 one-hour lifestyle program sessions (diet and physical activity skill building and problem solving) delivered about once weekly over 20-24 weeks, followed by monthly lifestyle maintenance sessions
16 one-hour lifestyle program sessions (diet and physical activity skill building and problem solving) delivered about once weekly over 20-24 weeks, followed by monthly lifestyle maintenance sessions
Weight Loss
We analyzed repeated outcome measures using longitudinal linear regression with 3 observations per participant (baseline, 6 months, and 12 months)
Time frame: 12 months
Self Report Physical Activity
Time frame: 12 months
Rate of Community Program Participation
Time frame: 6 months
| Milestone | One-on-one Lifestyle | Group-based Community Lifestyle |
|---|---|---|
| Started | 23 | 49 |
| Completed | 14 | 36 |
| Not completed | 9 | 13 |
We analyzed repeated outcome measures using longitudinal linear regression with 3 observations per participant (baseline, 6 months, and 12 months)
| kilograms | One-on-one Lifestyle | Group-based Community Lifestyle |
|---|---|---|
| Weight Loss | 4.37 (3.33 to 5.42) | 3.23 (2.16 to 4.30) |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| One-on-one Lifestyle | — | 0/23 (0%) | 0/23 (0%) |
| Group-based Community Lifestyle | — | 0/49 (0%) | 0/49 (0%) |
| Age, Categorical(Participants) | One-on-one Lifestyle | Group-based Community Lifestyle | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 23 | 49 | 72 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | One-on-one Lifestyle | Group-based Community Lifestyle | Total |
|---|---|---|---|
| Mean | 53.0 ± 10.7 | 52.8 ± 13.1 | 52.9 ± 11.9 |
| Sex: Female, Male(Participants) | One-on-one Lifestyle | Group-based Community Lifestyle | Total |
|---|---|---|---|
| Female | 17 | 42 | 59 |
| Male | 6 | 7 | 13 |
| Region of Enrollment(participants) | One-on-one Lifestyle | Group-based Community Lifestyle | Total |
|---|---|---|---|
| United States | 23 | 49 | 72 |
Plan to share: No
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Northwestern University