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Draft Research Plan

Draft Research Plan for Healthful Diet and Physical Activity to Prevent Cardiovascular Disease in Adults With Risk Factors: Behavioral Counseling Interventions

This opportunity for public comment expired on July 11, 2018 at 8:00 PM EST

Note: This is a Draft Research Plan. This draft is distributed solely for the purpose of receiving public input. It has not been disseminated otherwise by the USPSTF. The final Research Plan will be used to guide a systematic review of the evidence by researchers at an Evidence-based Practice Center. The resulting Evidence Review will form the basis of the USPSTF Recommendation Statement on this topic.

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.

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Draft: Preface

This systematic review will examine the evidence on the effectiveness of counseling on diet and physical activity to prevent cardiovascular disease (CVD) among adults with hypertension and dyslipidemia and in populations at increased risk of CVD due to any of multiple risk factors (as long as hypertension or dyslipidemia are among the possible risk factors). A concurrent systematic review on screening for abnormal blood glucose and type 2 diabetes mellitus will examine the effectiveness of counseling on diet and physical activity to prevent progression to diabetes and CVD among adults with prediabetes. Together, these two reviews will serve as the basis for the USPSTF recommendation on counseling on diet and physical activity in adults at increased risk of CVD.

Draft: Proposed Analytic Framework

Figure 1 is the analytic framework that depicts the four Key Questions to be addressed in the systematic review. The figure illustrates how counseling interventions for adults and older adults with known CVD risk factors (hypertension or elevated blood pressure, dyslipidemia, calculated 10-year CVD risk >7.5%, and mixed risk factors) may result in improved health outcomes (CVD events and related morbidity, CVD and all-cause mortality, and quality of life measures) (Key Question 1). Additionally, the figure illustrates how counseling interventions for adults and older adults with known CVD risk factors may have an effect on intermediate outcomes (change in CVD risk factors: blood pressure, lipids, body mass index or weight, dichotomized versions of CVD risk factors, and calculated 10-year CVD risk) (Key Question 2) and behavioral outcomes (dietary intake, physical activity, and sedentary behavior) (Key Question 3). There is also a question related to potential harms resulting from counseling interventions for adults and older adults with known CVD risk factors (Key Question 4).

Abbreviations: BMI=body mass index; BP= blood pressure; CVD=cardiovascular disease.

Draft: Proposed Key Questions to Be Systematically Reviewed

  1. Do primary care–relevant counseling interventions on diet and physical activity improve CVD health outcomes (e.g., morbidity and mortality) in adults with known CVD risk factors (hypertension, dyslipidemia, or a mix of risk factors)?
    1. Are there population characteristics that influence the effectiveness of the interventions?
    2. Are there intervention characteristics that influence the effectiveness of the interventions?
  2. Do primary care–relevant counseling interventions on diet and physical activity improve CVD intermediate outcomes (e.g., blood pressure, lipid levels, fasting glucose, and body mass index) in adults with known CVD risk factors (hypertension, dyslipidemia, or a mix of risk factors)?
    1. Are there population characteristics that influence the effectiveness of the interventions?
    2. Are there intervention characteristics that influence the effectiveness of the interventions?
  3. Do primary care–relevant counseling interventions on diet and physical activity improve behavioral outcomes (e.g., diet, physical activity, and sedentary behavior) in adults with known CVD risk factors (hypertension, dyslipidemia, or a mix of risk factors)?
    1. Are there population characteristics that influence the effectiveness of the interventions?
    2. Are there intervention characteristics that influence the effectiveness of the interventions?
  4. What are the harms of primary care–relevant counseling interventions on diet and physical activity in adults with known CVD risk factors (e.g., hypertension, dyslipidemia, impaired fasting glucose, or impaired glucose tolerance)?

Draft: Proposed Contextual Questions

Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.

  1. What is the relationship between behavioral outcomes (i.e., diet and physical activity) and health outcomes (i.e., cardiovascular morbidity and mortality, all-cause mortality, and quality of life)?
  2. What is the relationship between intermediate outcomes (i.e., blood pressure, low- and high-density lipoprotein levels, and fasting glucose) and health outcomes?

Draft: Proposed Research Approach

The Proposed 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 Review. Criteria are overarching as well as specific to each of the key questions (KQs).

  Include Exclude
Condition definition Dietary counseling may involve any of the following:
  • Increased consumption of fruits, vegetables, whole grains, fat-free or low-fat dairy, and lean proteins
  • Limited consumption of sodium, saturated fat, transfat, and sugar-sweetened food and beverages

Physical activity counseling may involve any of the following:

  • Aerobic activities that involve repeated use of large muscles, such as walking, cycling, and swimming
  • Resistance training designed to improve physical strength
  • Reduction of sedentary behaviors
Aspects of diet that are out of scope include:
  • Dietary calcium and other vitamin, micronutrient, and antioxidant supplementation
  • Alcohol moderation

Aspects of physical activity that are out of scope include:

  • Balance
  • Flexibility
  • Gait
Populations Adults age >18 years with known hypertension, dyslipidemia, metabolic syndrome, or 10-year CVD risk ≥7.5% based on a CVD risk assessment tool, or trial inclusion criteria specifies that population has ≥1 CVD risk factors Trials limited to:
  • Children and adolescents
  • Parents (if intended behavior change is directed toward children)
  • Persons with impaired fasting glucose/impaired glucose tolerance
  • Persons with any acute disease (other than hypertension or dyslipidemia)
  • Persons with known CVD or diabetes mellitus, such that >50% of trial participants have known CVD, severe chronic kidney disease, or diabetes
  • Pregnant women with gestational diabetes
  • Persons in institutions
  • Persons with severe and persistent mental illness
  • Persons with cognitive impairment
Settings
  • Trials conducted in or recruited from primary care (including obstetrics-gynecology, internal medicine, family medicine, and military health clinics) or in a setting otherwise generalizable to primary care
  • Trials in countries rated as “very high” on the Human Development Index (based on 2015 indicators)
Settings not generalizable to primary care (e.g., inpatient hospital units, emergency departments, nursing home and other institutional settings, school-based programs, occupational settings, and other community-based settings); dental clinics
Interventions
  • Any behavioral-based counseling intervention, either alone or as part of a larger multicomponent intervention on healthy diet and nutrition, physical activity, or both, including ≥1 of the following elements: assessment with feedback, advice, collaborative goal-setting, assistance, or arranging further contacts
  • Conducted in a primary care setting or judged to be feasible in primary care
  • Limited guided physical activity (i.e., 1 to 2 sessions) or provision of food samples allowed if intention is to teach or demonstrate healthy lifestyle principles
  • Optional or access to guided physical activity or exercise classes allowed

 

  • Noncounseling interventions (e.g., use of incentives, supervised exercise with the goal of assessing effects of exercise)
  • Interventions providing controlled diets
  • Counseling interventions aimed at diabetes prevention, falls prevention, depression, cognitive functioning, or disease prevention other than CVD
  • Prenatal or postnatal dietary counseling
  • Counseling interventions that are primarily community-based, nonreferral (e.g., occupational/worksite or school-based); social marketing (e.g., media campaigns); or policy (e.g., local or state public/health policy)
  • Stress management interventions (e.g., meditation, yoga, tai chi)
Comparisons
  • No intervention (e.g., waitlist, usual care)
  • Minimal intervention (e.g., pamphlets, links to general information online, in-person counseling ≤60 minutes annually [estimated], information similar to what patients can receive through usual care in a primary care setting but without personalized prescriptions based on standardized assessment)
  • Attention control (e.g., similar format and intensity but intervention is on a different content area)
  • Comparative-effectiveness trials without a control (as defined in inclusion column)
  • Physical activity only: Studies in which participants in the control group are instructed not to exercise
Outcomes
  • KQ 1 (health outcomes):
    • Cardiovascular events and related morbidity (e.g., stroke, myocardial infarction, heart failure)
    • Cardiovascular and all-cause mortality
    • Quality of life measures and related outcomes (e.g., functioning, well-being)
  • KQ 2 (intermediate outcomes):
    • Blood pressure
    • Total, low-density lipoprotein, and high-density lipoprotein cholesterol
    • Body mass index, weight, and percent body fat
    • Dichotomized versions of CVD risk factors (hypertension, dyslipidemia, diabetes, overweight or obesity, incidence of metabolic syndrome)
    • Calculated 10-year CVD risk
  • KQ 3 (behavioral outcomes):
    • Dietary intake or patterns
    • Physical activity
    • Sedentary behavior
  • KQ 4 (adverse outcomes):
    • Harms requiring medical attention (e.g., nutritional deficiency, musculoskeletal injury, cardiovascular event)
  • Initiation or withdrawal of medication
  • Knowledge, attitudes, or self-efficacy
  • Mental health symptom scores
  • Balance or flexibility
  • Followup of <6 months or <60%
Study Designs
  • All KQs: Fair- to good-quality studies
  • KQs 1, 2: Systematic reviews, RCTs, and CCTs (RCTs only prior to 2001)
  • KQ 3: Systematic reviews, RCTs, CCTs, comparative cohorts, and population-based case-control studies
  • All KQs: Poor-quality studies
  • KQs 1, 2: Observational studies
  • KQ 3: Ecological studies, case-series, and case reports
Publication Date Trials published from 1990 to present Trials whose primary results were published prior to 1990

Abbreviations: CCT=controlled clinical trial; RCT=randomized, controlled trial.

Current as of: June 2018

Internet Citation: Draft Research Plan: Healthful Diet and Physical Activity to Prevent Cardiovascular Disease in Adults With Risk Factors: Behavioral Counseling Interventions. U.S. Preventive Services Task Force. June 2018.
https://www.uspreventiveservicestaskforce.org/Page/Document/draft-research-plan/diet-and-physical-activity-to-prevent-cardiovascular-disease-in-adults-with-risk-factors-counseling

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