The purpose of this study is to compare ways of giving advice and providing support to improve diet and physical activity in adult primary care patients with elevated body mass index and dysglycemia.
This is a randomized comparative effectiveness trial to evaluate the health and economic effects of a community-based intensive lifestyle intervention for adult primary care patients with elevated body mass index and dysglycemia (either type 2 diabetes or pre-diabetes). The study will use qualitative and quantitative methods to assess reach, effectiveness, costs, adoption, implementation, and maintenance of a clinical-community partnership to offer intensive lifestyle intervention resources to eligible adult primary care patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
331
Standard clinical education is offered routinely by the participant's usual primary care team. Primary care teams receive educational outreach visits and are provided with clinical recommendations for lifestyle and cardiovascular risk factor management. Brief lifestyle advice is delivered by a study Research Assistant at baseline, 6, 12, and 24 months.
Standard clinical education offered routinely by the participant's usual primary care team. Primary care teams receive educational outreach visits for lifestyle and cardiovascular risk factor management. Brief lifestyle advice delivered by a study research assistant at baseline, 6, 12, and 24 months. AND, participant offered free of charge access to an intensive lifestyle intervention offered in a community setting. Lifestyle interventions are delivered in community settings by lay instructors from community organizations who are centrally trained by the study team.
YMCA of Metro Chicago
Chicago, Illinois, United States
McGaw YMCA
Evanston, Illinois, United States
Percent Change in Body Weight
(Body weight at 12 months subtracted from baseline body weight) divided by baseline body weight. Negative numbers indicate a weight loss.
Time frame: Baseline to 12 months
Incremental Costs
The study will capture direct medical, direct non-medical, and indirect costs from individual participants. Mean changes in these costs will be compared across randomized study arms.
Time frame: 6, 12, and 24 months
Changes in Health State Utility
The study collects individual participant survey data that will include the Medical Outcomes Study Short Form-12 health-related quality of life questionnaire. Responses from the questionnaire are used to construct a validated numerical score that expresses global health-related quality of life across a range of 0 (death) to 1 (perfect health). Changes in this indicator will be evaluated.
Time frame: Baseline to 6,12, and 24 months
Percent Change in Body Weight
Time frame: Baseline to 6 and 24 months
Percent Change in Blood Total Cholesterol
Time frame: Baseline to 6, 12, and 24 months
Percent Change in A1c
Time frame: Baseline to 6, 12, and 24 months
Percent Change in Blood Pressure
Time frame: Baseline to 6, 12, and 24 months
Percent Change in Dietary Composition
Time frame: Baseline to 6, 12, and 24 months
Percent Change in Physical Activity
Time frame: Baseline to 6, 12, and 24 months
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