Obesity, Overweight, Pre-diabetic State
Conditions
Brief summary
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.
Interventions
BEHAVIORALClinical referral to 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
BEHAVIORALClinical 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
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No
Inclusion criteria
25 years of age or older Body-mass index of \>= 24 kg/m2 1. or more additional risk factors if age is \<45 \- Parent or sibling with diabetes * Minority race or ethnicity * History of gestational diabetes * Delivery of infant \>= 9 lbs. * History of high blood pressure * History of dyslipidemia * Polycystic Ovarian Syndrome * History of vascular disease Fasting Capillary Glucose 95 - 125 mg/dl 2-hour Post-challenge Capillary Glucose 140 - 199 mg/dl
Exclusion criteria
Diseases that could limit lifespan or increase risk with a lifestyle intervention - Cancer diagnosed in the past 5 years \- Significant Cardiovascular Disease \- A Yes response to any item on the modified Physical Activity Readiness Questionnaire \- Uncontrolled hypertension: systolic blood pressure \>180 mmHg or diastolic blood pressure \>105 mmHg * Heart attack, stroke, or transient ischemic attack within 6 months * Chest pain or unexplained dizziness or fainting with physical exertion * Chronic obstructive pulmonary disease or asthma needing home oxygen * Other chronic disease or condition, such as advanced arthritis, that could limit ability to become physically active or limit life span to \<5 years * Any other known reason for not participating in regular physical activity Exclusions related to metabolism - Past anti-diabetes medication use, except during gestational diabetes \- Use of a medications known to produce hyperglycemia \- Known disease leading to abnormal glucose metabolism Exclusions for conditions / behaviors likely to affect study conduct \- Unable or unwilling to provide informed consent * Unable to communicate with the pertinent clinic staff * Unable to read written English or Spanish
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Loss | 12 months | We analyzed repeated outcome measures using longitudinal linear regression with 3 observations per participant (baseline, 6 months, and 12 months) |
Secondary
| Measure | Time frame |
|---|---|
| Self Report Physical Activity | 12 months |
| Rate of Community Program Participation | 6 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| One-on-one Lifestyle Clinical referral for diabetes prevention lifestyle intervention at School of Medicine campus | 23 |
| Group-based Community Lifestyle Clinical referral to group diabetes prevention lifestyle intervention program in community | 49 |
| Total | 72 |
Baseline characteristics
| Characteristic | Group-based Community Lifestyle | One-on-one Lifestyle | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 49 Participants | 23 Participants | 72 Participants |
| Age, Continuous | 52.8 years STANDARD_DEVIATION 13.1 | 53.0 years STANDARD_DEVIATION 10.7 | 52.9 years STANDARD_DEVIATION 11.9 |
| Region of Enrollment United States | 49 participants | 23 participants | 72 participants |
| Sex: Female, Male Female | 42 Participants | 17 Participants | 59 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 23 | 0 / 49 |
| serious Total, serious adverse events | 0 / 23 | 0 / 49 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| One-on-one Lifestyle | Weight Loss | 4.37 kilograms |
| Group-based Community Lifestyle | Weight Loss | 3.23 kilograms |
Secondary
Rate of Community Program Participation
Time frame: 6 months
Secondary
Self Report Physical Activity
Time frame: 12 months