Body Weight, Diabetes Mellitus, Endocrine System Diseases, Glucose Metabolism Disorders, Hyperglycemia, Metabolic Diseases, Nutrition Disorders, Obesity, Overnutrition, Overweight, Signs and Symptoms
Conditions
Keywords
Prevention & Control, Hyperglycemia, Obesity, Diabetes Mellitus, Cost Benefit Analysis
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALStandard Lifestyle Advice
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.
BEHAVIORALAdvice Plus Lifestyle Intervention
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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years of age or older, AND 2. Body-mass index of ≥ 24 kg/m2, AND 3. Documented Dysglycemia: Either by verification of laboratory test (Fasting Plasma Glucose 100-125 mg/dl OR 2-hour Post-challenge Plasma Glucose 140-199 mg/dl OR A1c 5.7%-10.9%) OR confirmation of Type 2 diabetes mellitus by self-report with verification
Exclusion criteria
(any of the following): Diseases/Conditions that could limit lifespan and/or increase risk with a lifestyle intervention: 1. Significant cardiovascular disease: * Uncontrolled hypertension: systolic blood pressure \>180 mmHg or diastolic blood pressure \>105 mmHg * A1c \> 10.9% * Heart attack, stroke, or transient ischemic attack (TIA) in the past 6 months * Chest pain, dizziness, or fainting with physical exertion 2. Lung disease: * Chronic obstructive airways disease or asthma requiring home oxygen 3. Pregnancy 4. Any other known condition that could limit ability to become physically active or limit life span to \<5 years Exclusions related to metabolism: 1. Use of medications known to produce hyperglycemia 2. Known disease leading to abnormal glucose metabolism, other than diabetes mellitus, including Cushing's syndrome; acromegaly; pheochromocytoma; chronic pancreatitis Exclusion for conditions or behaviors likely to affect the conduct of the study: 1. Unable or unwilling to provide informed consent 2. Unable to communicate with the pertinent research study staff 3. Unable to read written English or Spanish
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Body Weight | Baseline to 12 months | (Body weight at 12 months subtracted from baseline body weight) divided by baseline body weight. Negative numbers indicate a weight loss. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Health State Utility | Baseline to 6,12, and 24 months | 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. |
| Percent Change in Body Weight | Baseline to 6 and 24 months | — |
| Percent Change in Blood Total Cholesterol | Baseline to 6, 12, and 24 months | — |
| Incremental Costs | 6, 12, and 24 months | 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. |
| Percent Change in Blood Pressure | Baseline to 6, 12, and 24 months | — |
| Percent Change in Dietary Composition | Baseline to 6, 12, and 24 months | — |
| Percent Change in Physical Activity | Baseline to 6, 12, and 24 months | — |
| Percent Change in A1c | Baseline to 6, 12, and 24 months | — |
Countries
United States
Participant flow
Pre-assignment details
Potential participants were prescreened on the phone and attended a baseline visit for further screening and enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Standard Lifestyle Advice Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant).
Standard Lifestyle Advice: Standard clinical education is offered routinely by the participant's usual primary care team. Brief lifestyle advice is delivered by a study Research Assistant at baseline, 6, 12, and 24 months. | 167 |
| Advice Plus Lifestyle Intervention Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant) Plus access to an intensive group-based lifestyle intervention offered in a community setting.
Standard Lifestyle Advice: See Standard Lifestyle Advice arm.
Advice Plus Lifestyle Intervention: Standard clinical education offered by the participant's usual primary care team. 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. | 164 |
| Total | 331 |
Baseline characteristics
| Characteristic | Standard Lifestyle Advice | Advice Plus Lifestyle Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 43 Participants | 39 Participants | 82 Participants |
| Age, Categorical Between 18 and 65 years | 124 Participants | 125 Participants | 249 Participants |
| Age, Continuous | 56.6 years STANDARD_DEVIATION 12.2 | 57.1 years STANDARD_DEVIATION 10.6 | 56.9 years STANDARD_DEVIATION 11.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 43 Participants | 48 Participants | 91 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 124 Participants | 116 Participants | 240 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 9 Participants | 6 Participants | 15 Participants |
| Race (NIH/OMB) Black or African American | 54 Participants | 50 Participants | 104 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 37 Participants | 44 Participants | 81 Participants |
| Race (NIH/OMB) White | 63 Participants | 62 Participants | 125 Participants |
| Region of Enrollment United States | 167 participants | 164 participants | 331 participants |
| Sex: Female, Male Female | 81 Participants | 85 Participants | 166 Participants |
| Sex: Female, Male Male | 86 Participants | 79 Participants | 165 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 167 | 0 / 164 |
| other Total, other adverse events | 0 / 167 | 0 / 164 |
| serious Total, serious adverse events | 10 / 167 | 10 / 164 |
Outcome results
Primary
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
Population: Participants who completed weight measurements at the baseline and 12 month exam
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Lifestyle Advice | Percent Change in Body Weight | -0.15 percentage of change | Standard Deviation 4.05 |
| Advice Plus Lifestyle Intervention | Percent Change in Body Weight | -1.42 percentage of change | Standard Deviation 4.45 |
p-value: 0.017Regression, Linear
Secondary
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
Secondary
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
Secondary
Percent Change in A1c
Time frame: Baseline to 6, 12, and 24 months
Secondary
Percent Change in Blood Pressure
Time frame: Baseline to 6, 12, and 24 months
Secondary
Percent Change in Blood Total Cholesterol
Time frame: Baseline to 6, 12, and 24 months
Secondary
Percent Change in Body Weight
Time frame: Baseline to 6 and 24 months
Secondary
Percent Change in Dietary Composition
Time frame: Baseline to 6, 12, and 24 months
Secondary
Percent Change in Physical Activity
Time frame: Baseline to 6, 12, and 24 months