Obesity, Overweight, Prediabetic 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 increased risk for the disease. The lifestyle program used, however, was not designed for delivery on a public health scale. Successful community translation of the DPP's findings will require close collaboration with an established community organization committed to improving community health and experienced in implementing sustainable health and wellness programs. With exceptional reach into diverse U.S. communities, the Young Mens Christian Association (YMCA) may be an ideal community partner. We have been collaborating with the YMCA organization for over a year to design a robust recruitment and implementation model that is sensitive to the unique needs and resources of a community organization. We now propose to evaluate if a group-based adaptation of the DPP lifestyle intervention can be successfully implemented by YMCA staff, in YMCA facilities. We have designed this study to develop preliminary data about the reach, effectiveness, and consistent implementation of the DPP lifestyle intervention in this context. This pilot study has two primary aims: 1) to demonstrate the extent to which YMCA staff trained by DPP study personnel can administer a group-based adaptation of the DPP lifestyle intervention in a fashion consistent with DPP intervention protocols, and 2) to evaluate if the intervention program delivered by the YMCA results in changes in body mass, physical activity, and dietary intake that are consistent with a level found to be associated with diabetes risk reduction during the DPP trial. We will also collect valuable data about the feasibility and reach of a selective, community-based marketing and screening approach for recruiting program participants. In combination, these data will enable us to design and conduct a larger, future 3-year trial focusing on the effectiveness and sustainability of community DPP translation in multiple YMCA settings.
Interventions
BEHAVIORALBrief counseling plus group diabetes prevention in community
Brief counseling at measurement visits: education about diabetes and the importance of medical follow-up for determining the most appropriate strategies to decrease this risk, Group diabetes prevention in community: 16 weekly group lifestyle behavior change visits followed by monthly group lifestyle behavior change visits.
BEHAVIORALBrief Counseling for pre-diabetes alone
Brief counseling at measurement visits: education about diabetes and the importance of medical follow-up for determining the most appropriate strategies to decrease this risk.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
i. 18 years of age or older ii. Body-mass index of \>= 24 kg/m2 iii. ADA diabetes risk assessment score \>= 10 (see below) iv. Casual capillary blood glucose \>= 110 mg/dl
Exclusion criteria
i. Exclusions for diseases likely to limit life span and/or increase risk of interventions: A. Cancer requiring treatment in the past 5 years B. Cardiovascular disease: 1. A Yes response to any item on the modified Physical Activity Readiness Questionnaire (see Appendix 2) 2. Uncontrolled hypertension: systolic blood pressure \>180 mmHg or diastolic blood pressure \>105 mmHg 3. Heart attack, stroke, or transient ischemic attack in the past 6 months, C. Lung disease: Chronic obstructive airways disease or asthma requiring home oxygen ii. Exclusions related to metabolism: A. Diabetes at baseline evaluation B. Casual capillary blood glucose \>= 200 mg/dl C. History of anti-diabetic medication use (oral agents or insulin) except during gestational diabetes D. Pregnant female E. Self-report of disease associated with disordered glucose metabolism: Cushing's syndrome; acromegaly; pheochromocytoma; chronic pancreatitis iii. Exclusion for conditions or behaviors likely to affect the conduct of the study: A. Unable or unwilling to provide informed consent B. Unable to communicate with the pertinent clinic staff C. Unable to read written English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Weight | Baseline, 6 months | 6 months minus baseline |
Secondary
| Measure | Time frame |
|---|---|
| Physical Activity Level | Baseline, 6 months |
| Rate of Community Program Participation | Baseline, 6 months |
| Change in Dietary Composition | Baseline, 6 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental: 1: Brief Counseling Plus Group Lifestyle Brief counseling for pre-diabetes plus access to a group-based diabetes prevention lifestyle intervention in the community | 46 |
| Active Comparator: 2: Brief Counseling Alone Brief Counseling for pre-diabetes alone without access to group lifestyle | 46 |
| Total | 92 |
Baseline characteristics
| Characteristic | Active Comparator: 2: Brief Counseling Alone | Experimental: 1: Brief Counseling Plus Group Lifestyle | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 1 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 43 Participants | 45 Participants | 88 Participants |
| Age, Continuous | 60.1 years STANDARD_DEVIATION 10.5 | 56.5 years STANDARD_DEVIATION 9.7 | 58.3 years STANDARD_DEVIATION 10.1 |
| Region of Enrollment United States | 46 participants | 46 participants | 92 participants |
| Sex: Female, Male Female | 28 Participants | 23 Participants | 51 Participants |
| Sex: Female, Male Male | 18 Participants | 23 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Change in Weight
6 months minus baseline
Time frame: Baseline, 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Experimental: 1: Brief Counseling Plus Group Lifestyle | Change in Weight | -6.0 percentage of change in weight |
| Active Comparator: 2: Brief Counseling Alone | Change in Weight | -2.0 percentage of change in weight |
Secondary
Change in Dietary Composition
Time frame: Baseline, 6 months
Secondary
Physical Activity Level
Time frame: Baseline, 6 months
Secondary
Rate of Community Program Participation
Time frame: Baseline, 6 months