Final Research Plan
Healthy Diet: Behavioral Counseling in Primary Care, January 2003
February 03, 2014
Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.
The final Research Plan is used to guide a systematic review of the evidence by researchers at an Evidence-based Practice Center. The resulting Evidence Report forms the basis of the USPSTF Recommendation Statement on this topic.
Figure 1 is the analytic framework that depicts the four Key Questions (KQs) to be addressed in the systematic review. The figure illustrates how behavioral counseling interventions for healthy diet and/or physical activity may improve cardiovascular disease (CVD) health outcomes (KQ 1) in adults and older adults (age ≥18 years) with known CVD risk factors. The figure also depicts how these interventions may influence intermediate health outcomes associated with CVD (KQ 2) or associated health behaviors (KQ 3). In addition, the figure depicts whether these interventions have any potential harms (KQ 4).
Abbreviations: BMI = body mass index; CVD = cardiovascular disease.
- Do primary care–relevant behavioral counseling interventions for healthy diet and/or physical activity improve cardiovascular disease (CVD) health outcomes (e.g., morbidity and mortality) in adults with known CVD risk factors (e.g., hypertension, dyslipidemia, impaired fasting glucose, metabolic syndrome)?
- Are there population or intervention characteristics that influence the effectiveness of the interventions?
- Do primary care–relevant behavioral counseling interventions for healthy diet and/or physical activity improve intermediate outcomes associated with CVD (e.g., blood pressure, lipid levels, fasting glucose, body mass index) in adults with known CVD risk factors (e.g., hypertension, dyslipidemia, impaired fasting glucose, metabolic syndrome)?
- Are there population or intervention characteristics that influence the effectiveness of the interventions?
- Do primary care–relevant behavioral counseling interventions for healthy diet and/or physical activity change associated health behaviors in adults with known CVD risk factors (e.g., hypertension, dyslipidemia, impaired fasting glucose, metabolic syndrome)?
- Are there population or intervention characteristics that influence the effectiveness of the interventions?
- What are the adverse effects of primary care–relevant behavioral counseling interventions for healthy diet and/or physical activity in adults with known CVD risk factors (e.g., hypertension, dyslipidemia, impaired fasting glucose, metabolic syndrome)?
The Research Approach identifies the study characteristics and criteria that the Evidence-based Practice Center will use to search for publications and to determine whether identified studies should be included or excluded from the evidence report. Criteria are overarching as well as specific to each of the key questions (KQs).
| Inclusion | Exclusion | |
|---|---|---|
| Condition definition | Healthy diet is one designed to improve or maintain optimal health, which includes:
Physical activity may involve either:
|
Aspects of a healthy diet that are out of scope include:
Aspects of physical activity that are out of scope include:
|
| Populations |
|
Studies limited to:
Healthy diet only: persons requiring a specialized diet (e.g., kidney disease) Physical activity only: persons with specific physical activity requirements or limitations for health reasons (e.g., cardiac or physiotherapy rehabilitation patients) |
| Settings |
|
Settings not generalizable to primary care (e.g., inpatient hospital units, emergency departments, nursing homes and other institutionalized settings, school-based programs, occupational settings, and other community-based settings); dental clinics |
| Interventions | Any behaviorally-based counseling intervention, alone or as part of a larger multicomponent intervention on healthy diet and nutrition, physical activity, or both, including one or more of the following elements: assessment with feedback, advice, collaborative goal-setting, assistance, or arranging further contacts
Either conducted in a primary care setting or judged to be feasible in primary care:
Or must be primary care–referable, such that it is available for referral in most communities |
|
| Comparisons | Control arm with no intervention (e.g., wait-list control, usual care), minimal intervention (e.g., pamphlets, single annual session presenting information similar to what individuals can receive through usual care in a primary care setting), or attention control (e.g., similar format and intensity intervention on a different content area)
A control group can receive one visit annually, but no personalized prescription based on standardized assessment; may receive generic print materials twice yearly, but a more extensive print-based workbook would be considered comparative effectiveness and therefore excluded |
|
| Outcomes | KQ 1: Distal health outcomes (morbidity related to CVD, diabetes, hypertension, or hyperlipidemia; mortality)
KQ 2: Intermediate outcomes (blood pressure, hypertension, total cholesterol, low-density lipoprotein cholesterol or ratio of total/high-density lipoprotein cholesterol, serum fasting glucose or glucose tolerance, hemoglobin A1c, diabetes, weight, body mass index) KQ 3: Behavioral outcomes (physical activity, dietary intake or patterns), self-reported or objectively measured KQ 4: Adverse outcomes include any harms requiring medical attention (e.g., nutritional deficiencies, musculoskeletal injuries, cardiovascular events) |
|
| Study Designs | KQs 1–3: Systematic reviews, randomized controlled trials, controlled clinical trials (prior to 2001: randomized controlled trials only)
KQ 4: Systematic reviews, randomized controlled trials, controlled clinical trials, comparative cohorts, population-based case-control studies |
KQs 1–3: Any observational studies
KQ 4: Ecological studies, case-series, case reports |
| Publication Date | Trials published from 1990 to present | Trials whose primary results were published prior to 1990, in which the interventions were generally conducted in the 1970s |
The draft Research Plan was posted for public comment on the U.S. Preventive Services Task Force (USPSTF) Web site from January 29 to February 25, 2013. The USPSTF received several comments requesting that it include persons with diabetes in the review. Although management of diabetes is outside the scope of the USPSTF (which considers preventive services, not treatment and management), studies that enrolled participants with diabetes will be included as long as they are not a majority of the study population. In general, the population inclusion criteria were expanded and clarified where necessary in response to comments. In addition, the key questions were slightly revised to more clearly specify the cardiovascular risk factors being considered in the review.
Several comments suggested that the USPSTF consider reviewing the evidence on weight management or weight loss counseling. This review will not include those interventions, as they were included in the review on screening for and management of obesity. Multicomponent interventions are now included, except for those taking place in community- or work-based settings, as they are considered outside the focus of the USPSTF. The inclusion criteria for study settings were clarified to include trials conducted in countries with a “high” Human Development Index (i.e., countries with health, education, and living standards similar to the United States).
AHRQ Publication No. 13-05179-EF-5