# Presentation: 305869

## Behavior Change Consortium

**http://www1.od.nih.gov/behaviorchange/**
**Funded by NIH, AHA, RWJF**

**Behavior Change Consortium**

## Unique Characteristics of BCC

**Trans-NIH initiative to examine innovative  strategies for disease prevention**
**Focus on three lifestyle behaviors: exercise, nutrition, smoking**
**Multiple theory/multiple behavior approach**
**Populations ranging from children to frail elders**
**Identification of points of intervention **

## Fifteen BCC Grantees

**Borrelli****	**** ****	****Brown University**
**Charlson****	****	****Cornell University**
**Clark****	****	****	****University of Rhode Island**
**Elliot****	****	****	****Oregon Health Sciences**
**Garrison****	****	****University of Tennessee**
**Dzewaltowski****	****	****Kansas State University**
**Jeffery****	****	****University of Minnesota**
**King****	****	****	****Stanford**
**Peterson****	****	****Harvard**
**Resnick****	****	****University of Maryland**
**Resnicow****	****	****Emory**
**Sher****	****	****	****Illinois Institute of Technology**
**Strecher****	****	****University of Michigan**
**Toobert****	****	****Oregon Research Institute**
**Williams****	**** ****	****University of Rochester**

## Principles of Behavior Change Research

**Behavioral change is best accomplished by taking advantage of the multiple opportunities for change in the environment**
**Interventionists should consider why people change (mediators) and evaluate the ability of their intervention (intervention quality) to effect change in the mediators of interest**
**The goals of behavior change should be conceptualized as moving targets that are influenced by personal/ interpersonal, life situations, the environment, & policy**

## Principles of Behavior Change Research

**The goals of healthy behavior change should reflect a partnership between the participant and the provider and be stated in concrete terms**
**The adoption and maintenance of healthy behavior requires basic skills that can be taught**
**The maintenance of healthy behaviors requires planned follow-up**

## Targets Across the Life Course

**Primary Study Focus**
**Children or adolescents ****	****	****Two**
**Adults****	****	****	****	****Ten **
**Older adults ****	****	****	****Four**
****One study focus on both adults and children. **

## Behavioral/Theoretical Targets

**Eleven focused on at least two behaviors**
**Seven proposed to test at least two intervention strategies **
**Four tested both multiple behaviors and theoretical approaches**

## Theoretical Models/Approaches

**Behavioral Economics **
**Health Belief Model**
**Motivational interviewing,**
**Self-determination theory ****
**Social cognitive/learning theory ****
**Social ecological theory ****
**Social influence model**
**Theory of reasoned action**
**Transtheoretical model **
****Models Discussed in SBM Seminar**

## Most Frequent Key Mediators

**Decisional balance (pros and cons)**
**Goal-setting**
**Outcome expectations **
**Self-determination/autonomy**
**(Self-) efficacy **
**Social support **
**Stress**** **

## Cross-Cutting Themes

**Identifying mediators and pathways of intervention effect**
**Engaging and maintaining enrollment of participants **
** ****Assuring consistent delivery of interventions **
**Assessing transbehavioral, clinical and cost outcomes**
**Employing complex methodologies and emerging statistical applications **
**Translating behavior change research into real-world settings**

## Major Challenges for Behavior Change Research

**Identifying optimal points of intervention**
**Reaching all Americans, especially those with the greatest health risks**** **
**Maintenance of adoption of healthy lifestyles over time**

## Guiding Questions

**Are there certain points in the life-course where interventions are especially timely?**
**Do intervention approaches need to vary at different points in life-course?**
**Are some intervention approaches more suited to particular behavioral targets?**

## Today’s Talks

**Improving diet in children****	****Dzewaltowski (Kansas State University)**
**Smoking cessation in adults****	****William (University of Rochester)**
**Increasing exercise in older adults****	****Resnick (University of Maryland)**
**Enhancing recruitment and retention****	****Coday****	****(University of Tennessee)**

## Healthy Youth Places Promoting Nutrition and Physical Activity

**David A. Dzewaltowski, Ph.D.**
**Research and Extension Office of Community Health and **
**Department of Kinesiology**
**Kansas State University**

## Introduction

**The purpose of this presentation is to describe the process by which theory informed the development of the Healthy Places Framework, a place-based community development approach to building environments to promote healthy nutrition and physical activity in adolescents.****	****	****	****	**

## Extramural Funding

**National Institutes of Health (RO1 HD37367)**
**Healthy Youth Places Project**
**National Institute of Child Health and Human Development**
**National Institute of Nursing Research**
**Office of Disease Prevention**
**National Institute of Allergy and Infectious Diseases**
**Office of Dietary Supplements**
**Kansas Social and Rehabilitation Services, Office of Prevention (Connect Kansas)**
**Kansas Department of Health and Environment (Kansas LEAN, CHIPr)**
**Robert Wood Johnson Foundation (RE-AIM)**
**Kansas Health Foundation**
**United States Department of Agriculture (OPEN-K)**

## Agenda

**Theoretical Approach**
**Effectiveness Trial**
**Efficacy of Intervention**
**Social Cognitive Theory**
**Behavior Setting Theory**
**Reach of Intervention**
**Acceptance of Intervention**
**Availability of Intervention**
**Healthy Youth Places Project**
**Intervention : The Healthy Places Framework**
**Place-Based Diffusion System**
**Place-based Participation Planning and Implementation System**
**Resources**
**Multi-level Evaluation Model**

## A Place-Based Approach to Moving Public Health Outcomes

**Principle 1 (Efficacy Hypothesis)**
**Healthy places (social and physical environments where we live, learn, work and play) that contain critical elements will promote healthy physical activity and nutrition.**

## Social Cognitive Theory (Bandura, 1986)

**Environment**
**Variations in the social and physical features of developmental settings**
**Variations in the social and physical features of developmental settings caused due to intervention program effects**
**Person**
**Self-Efficacy**
**Outcome Expectations**
**Goals**
**Behavior **
**Regulatory Behavior**
**Health Behavior**

## Features of PositiveDevelopmental Environments

**Connection**
**“****Opportunities to Belong – Opportunities for meaningful inclusion (p. 9, National Research Counsel, 2001)”****	****	**
**“****Supportive Relationships- Warmth, closeness, connectedness; good communication, caring; support; guidance; secure attachment and responsiveness (p. 9, National Research Counsel, 2001)**

**Notes:**

regardless of one’s gender, ethnicity, sexual orientation, or disabilities; social inclusion, social engagement and integration; opportunities for sociocultural identity formation; and support for cultural and bicultural competence

## Autonomy
People need a place where they have control over the actions,choices, and autonomy.	
Youth-based; empowerment practices that support autonomy; making a real difference in one’s community; and being taken seriously.  Practices that include enabling; responsibility granting; and meaningful challenge. (p. 9, National Research Counsel, 2001)”

**People need a place where they have control over the actions,choices, and autonomy.****	**
**Youth-based; empowerment practices that support autonomy; making a real difference in one’s community; and being taken seriously.  Practices that include enabling; responsibility granting; and meaningful challenge. (p. 9, National Research Counsel, 2001)”**

**Features of Positive ****Developmental Environments**

## Skill building
Opportunities to learn physical, intellectual, psychological, emotional, and social skills;  exposure to intentional learning experiences;  opportunities to learn cultural literacy, media literacy, communication skills, and good habits of mind; preparation for adult employment; and opportunities to develop social and cultural capital (p. 9, National Research Counsel, 2001)”

**Opportunities to learn physical, intellectual, psychological, emotional, and social skills;  exposure to intentional learning experiences;  opportunities to learn cultural literacy, media literacy, communication skills, and good habits of mind; preparation for adult employment; and opportunities to develop social and cultural capital (p. 9, National Research Counsel, 2001)”**

**Features of Positive ****Developmental Environments**

## Healthy Norms 
People need a place where the norm is healthy behavior. 
Communities may not offer healthy examples or intentionally encourage healthy choices.
“Positive social norms-Rules of behavior; expectations; injunctions, ways of doing things; values and morals; obligations for service (p. 9, National Research Counsel, 2001)”.						

**People need a place where the norm is healthy behavior. **
**Communities may not offer healthy examples or intentionally encourage healthy choices.**
**“****Positive social norms-Rules of behavior; expectations; injunctions, ways of doing things; values and morals; obligations for service (p. 9, National Research Counsel, 2001)”.****	****	****	****	****	****	**

**Features of Positive ****Developmental Environments**

## A Place-Based Approach to Moving Public Health Outcomes

**Principle 1 (Efficacy Hypothesis)**
**Healthy places (social and physical environments where we live, learn, work and play) that contain critical elements will promote healthy physical activity and nutrition.**

## A Place-Based Approach to Moving Public Health Outcomes

**Central Efficacy Hypothesis for the Healthy Youth Places Project**
**Leader behavior targeting building healthy places that include healthy policies, programs and practices (connection, autonomy, skill-building, and health norms) will influence individual psychosocial processes and will promote healthy nutrition and physical activity.**

## Principle Two: Acceptance

**Hypothesis 2 (Participation Hypothesis)**
**Success in achieving environmental change to build healthy places is enhanced by the active participation by members of the target audience in defining their own high-priority problems and goals and in developing and implementing solutions (Green et al., 1999).****	****	**
**C.A.S.H. Environment features at the leader level.**

## Principle Three: Availability

**Principle 3 (Diffusion Hypothesis)**
**The development of a decentralized diffusion network that links program delivery expertise with place leaders that have sustained contact with the target audience over time will increase the availability of the intervention.**
**Diffusion Theory**
**Barker (1968)**
**Rogers (1995)**
**Ecological Theory**
**Brofenbrenner (1999)**
**McLeroy et al. (1988)**

## Research Design

**Group Randomized Trial**
** ****1999-2000 School Recruitment**
**Control for influence of season on diet and activity.**
**March 6th Grade (Baseline Assessment)**
**March 7th Grade **
** ****Site Coordinator, Team and Youth Environmental Change Training and Technical Support**
**March 8th Grade**
**Site Coordinator, Team and Youth Environmental Change Training and Technical Support**
**March 9th Grade (Follow-up)**
**New Environment Follow-up**

## Target Population

**School**
** ****Level of recruitment and random assignment**
**Age**
** ****11-15**
**Recruited in Grade 6 and followed through Grade 9**
**SES categories**
**Measured by participation in free and reduced lunch**
**Total sample size**
**16 schools (8 intervention, 8 comparison)**

## Primary Outcome Measures

**Fruit and Vegetable Consumption**
**Food Frequency Questionnaire**
** ****(Rockett et al., 1997) **
**Physical Activity**
**Previous Day Physical Activity Recall **
**(PDPAR; Weston, Petosa, & Pate, 1996) **

## Primary Outcome Measures

**Verification Strategy**
**Activity monitoring of sub sample (BioTrainer)**
**Computerized slide card tracking of individual behaviors**
** ****school lunch purchases**
** ****attendance and choice at after school program**

## Intervention

**Efficacy**
**Intervention targets building critical elements in two key places (after school programs, school lunch).**
**Acceptance**
**Youth and adults participate in developing the intervention using the place-based planning process.**
**Availability**
**Establishment of Place-Based Diffusion System that links youth, youth and adult leaders (change team), and site leaders, and experts (site leader learning community). **

## Place-Based Diffusion System

**Acceptance and Availability**
**Training Staff**
**Leaders of Site Coordinators**
**Site Leaders**
**Leaders of Place Leaders**
**Place Leaders**
**Identify and organize the participants ( key stakeholders; adults and youth) in the place.**

## Place-Based Diffusion System

**Local paid site coordinator**
**Four time yearly training**
**Monthly conference call with all school site leaders**
**Continuous technical assistance through phone and web**
**Site change team**
**Regular meetings (Bimonthly-monthly)**
**Led by site coordinator**
**Participants include place leaders and children**
**At least a two (children) to one (adult) ratio **

## Site Leader Performance Community Resources

**Mastery Accomplishments**
**Group and coordinator strategic and action planning (Goal setting and feedback)**
**Social Modeling**
**Videos illustrating environmental change by other “like” schools**
**Social Persuasion**
**Training and technical support delivered to coordinator and change teams across school groups**
**Group coordinated social interaction among site leaders**
**Internet on line collaboration tools for site leaders**

## Change Team

**Reach and Appeal Strategies**
**Social Marketing P.S.A. **
**Critical Place Environment Elements**
**Connection**
**Autonomy**
**Skill Building**
**Healthy Norms**

## Change TeamInformation Sources

**Mastery Accomplishments**
**Group and coordinator strategic and action planning (Goal setting and feedback)**
**Social Modeling**
**Videos illustrating environmental change by other “like” schools**
**Social Persuasion**
**Training and technical support delivered to coordinator and change teams across school groups**
**Group coordinated social interaction**
**Internet on line collaboration tools for coordinators and participants across schools**

## Place-Based Participation, Planning and Implementation Model

**Step One - Target a Place**** **
**Step Two - Identify an outcome (PA, F&V, Skill building)**
**Step Three - Identify Outputs (Activities) to Focus efforts**
**Strategies to build the place?**
**Connection, Autonomy, Skill-Building, Healthy Norms**
**Strategies to promote the place? **
**Connection, Autonomy, Skill-Building, Healthy Norms**

## Place-Based Participation, Planning and Implementation Model

**Step Four – Check Quality**
**1) Identify and describe the targeted critical environmental processes of the planned objective.**
**2) Identify the targeted appeal processes of the objective.**
**3) Predict the frequency (Contact periods per week), duration (length of contact periods), and target population (number of children contacted) of the planned objective.  Attempt to develop an objective that increases the total time in contact with the targeted population. **
**Step Five - Identify Resources and Implement**
**Needs (Time, People, Skills, Money, etc.)**
**Action Steps**

## Multi-level Mediation Research Model

**Evaluating the multilevel mechanisms underlying the effectiveness of the framework.**

## A

**Intervention**

**Multilevel Mediation Research Model**

**Adolescent  Level**

**School  Level**

** ****Higher Level  Variable**
**Change Team Collective Efficacy to Change School Environments**

**Lower Lever**
**Perceived Environment**

**Lower  Level **
**Perceived Self**

**Primary Outcomes**
**PA**
**F&V**

**Higher Level  Variable**
**Implemented Environmental Change in Practices, Programs, and Policies**

**A**

**B**

**C**

**D**

## Self-Determination, Smoking, Diet & HealthA Behavior Change Consortium Study Supported by NIMH & NCI

**Geoffrey Williams MD, PhD**
**Edward Deci, PhD**
**Richard Ryan, PhD**
**University of Rochester**

## Outline

**Self-Determination Theory**
**Past research**
**Measures**
**Health Benefits of Tobacco Cessation & Diet Change w.r.t. Cholesterol**
**Relating SDT to PHS and NCEP Guidelines**
**Intervention content & goals of treatment**
**Conclusions**

## Motivation &  Health Behavior

**Motivation is human energy (psychological energy) directed at a particular goal**
**Energy and goals need to be accounted for to understand motivation and how to facilitate maintenance of the desired behavior or change.**
**Motivation for growth and health is intrinsic**

## Self-Determination Theory(Deci & Ryan)

**Autonomy****	****	****Autonomy support**
**Competence****	****	****Competence support**
**Relatedness****	****	****Relationship support**

## Self-Determination Theory 

_**Autonomous motivation**_** involves people feeling fully willing to regulate their behavior**
_**Controlled motivation**_** involves people feeling pressured by others or by themselves.**
_**Internalization**_** is an inherent, proactive process by which controlled motivations are transformed into autonomous motivation**

## Autonomy Support

**Elicit and acknowledge patients perspective (listen and reflect)**
**Provide effective options for change**
**Support patient initiatives for change**
**Provide a rationale for your suggestions**
**Minimize control**

## Self-Determination Model for Health

**Self-Determination Model for Health**

**Autonomy Support **
**vs. Control**
**Health Care Climate (HCCQ)**

**Individual Differences**
**Autonomous Orientation (GCOS)**

**Intrinsic vs. Extrinsic Values**

**Autonomy**
**(TSRQ)**
**Competence**
**(PCS)**
**Relatedness**

**Mental Health**

**Physical Health**
**Outcomes**

## Construct Measurement

**Autonomy supportiveness  (HCCQ)**
**6 items self report (7-point likert scale)**
**Autonomous, Controlled, Amotivated (TSRQ)**
**15 self-report items **
**Perceived competence**
**4 items self-report**

## Autonomy Support (HCCQ)

**Definition: The extent to which the practitioner listens to and acknowledges the patient’s perspective, supports initiatives, and minimizes control**
**I feel my HCP’s provide me with choices and options about handling my diabetes**
**My HCP’s try to understand how I see my diabetes before suggesting a new way to do things.**

## Autonomous Motivation (TSRQ)

**Definition:  The extent to which the patient feels self-initiating and volitional**
**The reason I would stop smoking permanently regularly is because:**
**I personally believe that stopping smoking is the best thing for my health. **
**Other people would be upset, if I smoked.**
**I would be ashamed of myself if I smoked.**

## Perceived Competence

**Definition: The extent to which the patient believes he/she can achieve the outcome**
**I feel confident in my ability to stop smoking permanently.  **
**I feel capable of improving my cholesterol by changing my diet.  **

## Past Research withPerceived Autonomy

**Associated Autonomous Motivation with **
**medical students counseling style (CV risk)**
**weight loss**
**adherence to medications and appointments**
**completion of alcohol depend treatment**
**30 month continuous abstinence from smoking**
**diabetes self-regulation**

## AUTONOMY SUPPORT (HCCQ)

**AUTONOMY SUPPORT (HCCQ)**

**AUTONOMY ORIENTATION (GCOS)**

**AGE**

**STARTING BMI**

**AUTONOMOUS REASONS T2 (TSRQ)**

**ATTENDANCE**

**FINAL BMI**

**X****2 ****[df=9, N=94]=6.18, p=.72**

**Williams, Grow, Freedman, Ryan, & Deci, JPSP, 1996**

**.90**

**.09**

**.33**

**.31**

**.34**

**-.23**

## Adolescent Values & Risk Behavior

**Parental Autonomy Support**

**Grade**

**Relative Extrinsic Aspirations**

**Risk Behavior Index**

**-.26*****

**.18****

**-.19****

**.18*****

**Williams, Cox, Hedberg, & Deci, J. Applied Social Psych. 2000**

**Adolescent Values & Risk Behavior**

## Adherence to Medications

**AS4**

**AS3**

**AM1**

**AM2**

**AM3**

**A1**

**A2**

**A3**

**AS2**

**AS1**

**.37**

**.78**

**.87**

**.40**

**.83**

**.67**

**.72**

**.70**

**.61**

**.70**

**.86**

**.79**

**.74**

**.60**

**Autonomy Support**

**Autonomous Motivation**

**Composite Adherence**

**From Williams, Rodin, Ryan, Grolnick, and Deci, Health Psychology, 1998**

**Adherence to Medications**

## Self-Determination Model for Health

**Self-Determination Model for Health**

**Autonomy Support **
**vs. Control**
**Health Care Climate (HCCQ)**

**Individual Differences**
**Autonomous Orientation (GCOS)**

**Intrinsic vs. Extrinsic Values**

**Autonomy**
**(TSRQ)**
**Competence**
**(PCS)**
**Relatedness**

_**Mental Health**_
**Depression**
**Anxiety**

_**Physical Health**_
**Not Smoking**
**Exercise**
**Weight Loss**
**Diabetes Control**
**Medication Adherence**
**Healthier Diet**
**Alcohol treatment**

## Health Benefits of Tobacco Cessation & Diet Change w.r.t. Cholesterol

**Our intervention was planned to support autonomy in the context of Guidelines for Tobacco Cessation (PHS, 2000) and National Cholesterol Education Program.**
**Review health risk and benefit information**
**Elicit patient perspective and values**
**Identify those who want to change**
**Establish plan for change if wanted**

## Actual Causes of Death 1990

**McGinnis & Foege,JAMA,1993**

## Health Benefits of Quitting

**Four Cancers:  **
_**Lung**_** after 10 years former smokers have 30-40% of risk of continued smokers**
_**Oral & Esophageal**_**  50% risk after 5 yrs ****Cardiovascular disease**
_**CHD**_** 50% reduction in 12 months**
_**Stroke**_** in 10 years risk is that of nonsmoker**
_**PVD**_** 50% reduction in risk for former smokers**

## NCEP Guidelines

**All patients in our study smoke**
**NHANES II 40% of our patients would not be at their goal cholesterol**
**Cholesterol and smoking are synergistic in causing vascular injury**
**Major cause of death for smokers is cardiovascular disease**
**Stroke 60,000 deaths per year**
**Coronary Artery disease 120,000 deaths per year**

## NCEP Guidelines

**Framingham Risk estimator predicts absolute risk for CAD based on **
**Age & Gender**
**Cholesterol, Total and HDL**
**Systolic Blood Pressure**
**Smoking**
**Anyone not at NCEP Cholesterol goal was placed in diet arms of our study in addition to the smoking arms.**

## Participants (N=1000)

**18  years of age and older**
**Smoke 5 cigarettes/day for the past month**
**Life expectancy >1.5 years**
**Read and write English**
**No history of psychotic disorder other than**
**depression, anxiety, previous substance abuse**
**All participants asked to have 2 FLP’s**

## Study Design

**Stratification: healthy vs elevated LDL-c**
**Healthy LDL-c (2 groups)**
**Community care: provided self help materials and links to care in community, including PCP**
**SDT intervention for Tobacco Dependence**
**Elevated LDL-c (3 groups)**
**Community Care for Chol and tobacco dependence**
**SDT Tobacco & Community Care for Chol**
**SDT Tobacco & Chol**

## The SDT Intervention

**Spanning 6 months**
**4 visits with counselors (6 if Diet & Tobacco)**
**Initial visit **
**1 hour in person with counselor**
**Subsequent contacts **
**average 20 minutes with counselor or MD**
**In person or by phone-chosen by patient**
**Intended to promote autonomy and competence**

## Critical Intervention Components

**Counselors elicit acknowledge, and accept pt’s choices about change **
**Assume smokers are ambivalent about change**
**Elicit both sides of ambivalence**
**Do not align with either side of ambivalence**
**Reflect patients feelings about change**
**Encourage patient to make decision and accept it**

## Critical Intervention Components

**Acknowledge that the patient is responsible**
**Facilitates internalization of the value of health-related change**

## Critical Intervention Components

**Acknowledge that the patient is responsible**
**Facilitates internalization of the value of health-related change**

## Critical Intervention Components

**The intervention is intended to facilitate change without pressuring participants**
**Starts by establishing a supportive relationship**
**Elicit day-to-day strivings (values)**
**ask how does smoking or diet help or hinder**
**summary reflection of strivings**
**Present 10 year absolute risk for CAD**
**Discuss possible health benefits of change**
**Inquire about patients willingness to change**

## Critical Intervention Components

**If not willing to change, counselors**
**accept participant’s choice**
**inquire about what would be necessary for them to be ready**
**reflect answer back**
**if participant doesn’t feel competent to change**
- counselor will offer that effective means for change exist
- problem solves to see if barrier can be adequately overcome for the participant to want to try.
- Again, elicit and respect participant’s choice

## Critical Intervention Components

**If the participant is willing to change**
**Negotiate a change date within 2-4 weeks**
**Skills building/problem solving**
**Teach withdrawal symptoms**
**Avoid even a puff of a cigarette**
**A central aspect of diet and tobacco use is a means for participant to cope with anxiety and depression**
**Identify problem situations, alcohol, negative affect**
**Establish quit plan**

## Critical Intervention Components

**Encourage securing extra-treatment support**
**family, friends, coworkers**
**Discuss effective pharmacotherapy**
**Explore participant preference**
**Review contraindications and side effects**
**Determine if cost is a factor**
**Establish if they will see their MD or Study MD**
**Arrange to see dietician regarding Chol **
**Arrange follow-up plan**
**Early in first week of change is important**

## Critical Intervention Components

**Relapse prevention**
**critical to  be nonjudgmental**
**identify if they have quit**
**elicit participant perspectives, depression**
**Acknowledge difficulty: most need 3 attempts**
**Reflect short successes & health improvements**
**Establish follow-up plan**
**plan to see them if successful or not**

## Measures & Follow-up

**4 Questionnaires**
**Baseline Demo, Auto, Comp, Tobacco Use**
**1 month, HCCQ, Auto, Comp, Tobacco Use**
**6 months, Auto, Comp, Tobacco Use**
**18 months Tobacco use, cotinine**
**Diet,   Chol x 2, dietary phone recall x3 at baseline, 6 months, and 18 months**

## Analyses

**ANOVAs to test between group differences**
**SEM to test:**
**SDT model for change**
**mediations**
**Outcomes**
**7 day point prevalance tobacco cessation**
**Change in dietary intake total calories and % cal from fat**

## Summary

**We have attempted to operationalize SDT by combining critical elements of autonomy support into the context of tobacco dependence and cholesterol guidelines**
**Elicit and acknowledge patients perspective ****(listen and reflect)**
**Provide effective options for change**
**Support patient initiatives for change**
**Provide a rationale for any recommendations**
**Minimize control**

## Theory Based Interventions for Older Adults

**Barbara Resnick, PhD,CRNP,FAAN,FAANP****University of Maryland**

## Theory Based Interventions

**Despite the potential benefits of exercise, it is difficult to get older adults to initiate exercise activity, and helping them adhere to an exercise regime is even more challenging **

## What Theory is Appropriate?

**Initial research exploring motivation in older adults admitted to rehabilitation programs following orthopedic events, and those participating in exercise programs indicated that motivation is multidimensional. **

## What Theory is Appropriate?

**In addition to the impact of actual performance of the behavior, motivation in older adults was influenced by: **
**1) beliefs, both self-efficacy and outcome expectations; **
**2) social supports; **
**3) individualized care**
**4) identification of goals; **
**5) spirituality;**
**6) physical sensations such as pain, or fatigue;**
**7) underlying personality, described as “self-determination”; **
**8) self-modeling or seeing role models.**

## What Theory is Appropriate?

**Findings from these studies were consistent with social cognitive theory and the theory of self-efficacy (Bandura, 1977; 1986; 1995;1997).  **

## The Theory of Self-Efficacy

**Specifically the theory of self-efficacy states that the stronger individuals believe in their ability to perform a course of action, and in the positive outcomes of those actions, the more likely they will be to initiate and persist in a given activity. **
**The Theory of Self-efficacy was derived from Social Cognitive Theory.**
**Social Cognitive Theory is based on triadic reciprocity suggesting that behavior, cognitive and other personal factors and environmental influences **_**all**_** operate interactively as determinants of each other.  **

## Slide 83

## The Theory of Self-efficacy

**There is mutual action between causal factors, and behavior can be manipulated by these interactions.**
**Bandura (1977; 1995) also identified four sources of information that influence self-efficacy expectations (and presumably outcome expectations).**
** ****all of which were identified by the older adults studied as influencing motivation and behavior. **

## The Theory of Self-efficacy

**These include **
**performance of the activity, **
**verbal encouragement, **
**exposure to role models, and **
**physiological feedback or physical sensations experienced during the activity. **

## Development of the Intervention: The Exercise Plus Program

**In addition to Performance of the Behavior...Interventions should:**
**strengthen the individual’s beliefs about the benefits of a behavior (focus on the person);**
**alter the environment by providing cues to exercise  (focus on the environment);**
**incorporate actual performance of the behavior and feedback related to performance (focus on behavior)**
**In addition to theoretical support there was empirical evidence that these interventions would be effective.**

## Development of the Intervention: The Exercise Plus Program

** ****Most commonly the interventions developed from the Theory of Self-efficacy have focused on actual performance of the behavior. **
**Prior research has shown that actual performance of exercise increases exercise adherence.**
**Therefore...One component of the program was to have a trainer visit the participant directly and teach and engage the individual in a combined aerobic and resistive exercise program.  **
**Visits ranged from 2 times per week down to once monthly over the course of 12 months.**

## Development of the Intervention: The Exercise Plus Program

**The Exercise Training component, which was developed by an exercise physiologist, incorporates both aerobic and resistive exercises focused on improving recovery for older women post hip fracture. **
**Verbal encouragement from a trusted, credible source in the form of counseling and education has been used alone, and with performance behavior, to strengthen efficacy expectations related to recovery, disease management and activity.**

## Development of the Intervention:The Exercise Plus Program

**Therefore...The first aspect of the Plus component provides education and encouragement.  **
**The exercise trainer uses an investigator-developed "Exercise After Your Hip Fracture" booklet to teach the participants the benefits of exercise post hip fracture and ways to overcome the barriers to exercising regularly.**
** ****In addition the trainer helps the participant identify both short (weekly) and long term goals with incentive gifts given when weekly goals are achieved.****  **
**Unpleasant sensations associated with exercise such as pain, fear and fatigue have frequently been reported to decrease exercise activity for older adults and influence self-efficacy expectations.  **

## Development of the Intervention:The Exercise Plus Program

**Therefore...Consideration of unpleasant physical sensations was included as part of the Plus component of the intervention.  **
**This involves the exercise trainer asking the participants at each supervised exercise session if they experience pain, fear, or fatigue associated with exercise that makes them not want to exercise.  **
**Specific techniques are then implemented to decrease those sensations**

## Interventions to Decrease Unpleasant Sensations

**Pain:**
**Have participant take pain med prior to exercise**
**Implement ice/heat treatments**
**Educate/encourage that exercise will help reduce pain not exacerbate it**

## Interventions to Decrease Unpleasant Sensations

**Fear**
**Educate/encourage that exercise will prevent future falls**
**Educate/encourage that they will not be be asked to do exercise they are not capable of performing**

## Interventions to Decrease Unpleasant Sensations

**Fatigue**
**Strees the importance of exercise to combat fatigue, and improve sleep**
**Encourage one half hour rest period prior to exercise**

## Development of the Intervention:The Exercise Plus Program

**referrals are made to a GNP if  those interventions are not effective**

## Development of the Intervention:The Exercise Plus Program

**Role modeling is included as one of the informational sources for self-efficacy expectations.**
** ****The actual impact of role models on older adults, however, is variable. **

## Development of the Intervention:The Exercise Plus Program

**Some older adults found exposure to role models to be encouraging, some found exposure to role models to be discouraging, and a third group were indifferent to exposure to role models. **

## Development of the Intervention:The Exercise Plus Program

**Self-modeling, in which people observe their own successful attainments achieved under specially arranged conditions, has also been used to strengthen efficacy expectations. **

## Development of the Intervention:The Exercise Plus Program

**Therefore...Exposure to self-modeling and providing visual cues to participants to exercise was incorporated into the Plus Program. **
**This includes providing participants with a picture of themselves exercising, an individually developed exercise calendar, and a large print write up of the exercises). **
**Also available for participants is an audiotape describing and counting out the exercises and providing music for the 20 minute aerobic component. **

## Measures

**It is anticipated that the performance component of the intervention will impact self-efficacy expectations more than outcome expectations;**
**The Plus components will impact both self-efficacy and outcome expectations**
**Measures should likewise be based on theory**

## Measures

**Self-efficacy for exercise**
**Outcome expectations for exercise**
**social supports for exercise**
**Mood**
**Health status**
**Function/strength**
**Adherence**

## Measurement

**The theory of self-efficacy has clear guidelines in terms of the development of measures**
**Self-efficacy is situation specific and dynamic, **
**Self-efficacy beliefs are measured against the levels of the task, or the challenges the individual encounters to successfully perform the task of interest. **
**measurement tools must be developed with respect to a specific task or activity.  **
**No single standardized measure of self-efficacy will be appropriate for all studies**

## Measurement

**operationalization of self-efficacy expectation has been based on Bandura's (1977) early work with snake phobias.  **
**This approach included a paper and pencil measure with a list of activities in a specific behavioral domain that were arranged from least to most difficult.  **
**The respondents first indicated whether or not they could perform the activity, and then evaluated the degree of confidence they had in performing the given activity.  **
**Respondents were given a 100-point scale, divided into 10-unit intervals ranging from 0 which is completely uncertain, to 100 which is completely certain**

## Measurement

**Magnitude is measured by calculating the number of tasks the participant believed he or she would be able to complete. **
**The strength, or degree of confidence is computed by adding the magnitude of expectancy scores and dividing by the total number of activities.  **
**Generality is measured by selecting items that indicate that the mastery of the specific activity being studied can be generalized **

## Measurement

**Two formats can be used to measure self-efficacy strength.  **
**dual-judgment format=the individual first states whether or not they can execute the given activity, then they rate the strength of their perceived efficacy.  **
**single-judgment format, the individual simply rates the strength of his or her perceived efficacy.  **
**The single-judgment format proves the same information, and is generally easier to use**

## Measurement

**Based on the early work measures of self-efficacy are developed by considering the tasks relevant to the behavior being studied and arranging the tasks in order of increasing difficulty. **
**For non-psychomotor behaviors it is difficult to determine the hierarchical level of the challenges encountered. **
**Random ordering of activities may be more appropriate **
**Empirically there was no difference in self-efficacy beliefs when random ordering was done as opposed to placing items in order of increasing difficulty **

## Measurement

**Because self-efficacy is situation specific it is essential to carefully consider the domain of interest and all the challenges involved in that area**
**Multiple qualitative studies focusing on self-efficacy and outcome expectations were done to help establish the items in the the SEE and OEE**

## Self-efficacy Items

**Using a scale of 0 to 10 (0 being not confident and 10 being very confident) how confident are you right now that you could exercise 3 times per week for 20 minutes if:**
**you were having pain in your hip**
**you were bored by the program or activity**
**you felt pain when exercising**
**You had to exercise alone**
**You did not enjoy it**
**You were too busy with other activities**
**You felt tired**
**You felt stressed**
**You felt depressed**

## Items on the Outcome Expectations for Exercise Scale

**The following are statements about the benefits of exercising.  State the degree to which you agree or disagree with these statements.**
**Makes me feel better physically**
**Makes my mood better in general**
**Helps me feel less tired**
**Makes my muscles stronger**
**Is an activity I enjoy doing**
**Gives me a sense of personal accomplishment**
**Makes me more alert mentally**
**Improves my endurance in performing my daily activities (personal care, cooking, shopping, light cleaning, taking out the garbage)**
**Helps to strengthen my bones **

## Advantages to Theory Based Interventions:

**Provide guidelines**
**Help build theory/science**
**Replicability**

## When Research and Reality Collide: Combating Life's Intrusionsin Follow-Up

**Mace Coday, University of Tennessee Health Science Center (UTHSC) on behalf of the Recruitment and Retention Committee for the BCC**

## The problem of underpowered trials

**Who is at risk and needs the intervention? *****Obtain adequate representation***
**Who can benefit by how much from the intervention? *****Obtain adequate numbers***
**Editorial from Buring J, NEJM, V. 343, No. 7**

## Underpowered trials can produce an inconclusive null result

**Intervention is not effective: ****Null conclusions correct**
**Intervention interpreted not effective when it is: ****Null conclusions incorrect**

**Notes:**
tttttt

## What do we know aboutretaining study members?

**Research on this  topic  has been ****descriptive in nature**
**Documented strategies have focused on ****longitudinal cohort studies**

## Strategies to track cohort members over time

**AIDS Cohort Study**
**Nurses’ Health Study**
**WHI Observational**
**ERSA**

**Enrollment, consent, and baseline **
**Bonding**
**Frequency of Contact**
**Staff Characteristics**
**Incentives**

## No systematic information on retention in behavioral intervention trials

**Recruitment and Retention Committee for BCC formed in 1999**
**Recognized need for adequate representation/reach using a recruitment/retention approach flexible enough to address a diverse range of participants ****(e.g. age, race, gender, SES, health status) **

## Life-Course approach adopted

**Reps from 15 sites met to discuss retention barriers in open-ended group format**
**Most common ****Life-Course themes****, which emerged, were co-morbidity, family concerns, time/priority by age group, complexity of intervention**

## Life-Course approach adopted

**8 global retention strategies**** were adopted and reviewed to address common life-course themes**
**During yr. 3, reps surveyed by e-mail using open ended table to report ****specific retention strategies**** implemented at 3 levels (individual, provider, inst.)**

## Life-Course themes affecting retention by subgroups

_**Older Adults**_**:Co-morbidity/illness/ health status;family concerns; transportation; retirement**
_**Adults’ w/ Disease**_**:Co-morbidity; family demands (caretaker role); transportation**

## Life-Course themes affecting retention by subgroups

_**Adults, general**_**: Time/priorities by age group (career, family, school); family demands**
_**Adults, low SES**_**: Time/sacrifices by age group; family demands; co-morbidity, cultural barriers (transient, transportation, language, appointment)**
_**Children/Adolescents**_**: Ran out of time and did not discuss this age group**

## Solution-oriented process to guide problem-solving experience

_**Assess Commitment**_** based on above life-course themes**
_**Determine Barriers**_** with the participant as active collaborator**
_**Evaluate Responsiveness**_** of participant to the strategies (see 8 strategies)**
_**Triage**_** to other levels in your system (e.g. fellow staff, investigators, PI)**
_**Incentivize**_** (new word) the plan for them, earning or recognition for something meaningful**

## Phase 1 survey results: Individual Level 

**Retention strategy responses from 12 of 15 sites were obtained via open-ended survey**
**65 different responses were reported with some strategies listed by more than one site **
**Responses were categorized by a rater into the 8 global life-course strategies presented below **

## Strategies presented from most to least commonly endorsed 

**Based upon responses, the 8 global categories were modified**
**Added 2 categories based on high response rates “Incentive” and “Other” **
**2 categories had low endorsement (Patience and Streamlining) and could be considered for collapsing **

## Incentives and Feel Goods12 endorsements

**Peer/staff  bonding, newsletters (w/ testimonials)**
**Verbal thank you, birthday/ holiday cards **
**Mail-gospel music tapes, potholder w/ logo**
**Lifestyle items for goal keeping**
**Provide incentive gifts for participation or attendance**
**Provide money compensation or gift certificate for interview/visit**
**Give framed Polaroid picture of mom and baby**

## Enhance Prioritizing Skills 10 endorsements

**Emphasize importance--helping others & national scope of group**
**PI calls/ MD letters**
**Emphasize need for complete data **
**Listen to & problem-solve reasons for missing**
**Discuss motivations (QOL, family, health)**
**Discuss reasons joined/benefits **
**Remind of commitment and encourage follow  through**
**Discuss medical procedures provided (stress testing, lab work, diet and/or exercise consultation)**

**Notes:**
Help participant decide what’s most important right now versus in the future

## Enlist Support9 endorsements 

**Call relatives, friends, emergency listing, recovery center contacts**
**Ask person on phone best time to reach, or if another # is better**
**Speak with significant other if  reservations about continuing**

**Notes:**
Recognize that study staff don’t have all the answers or all the resources and can draw on participant assistance by asking for help with chain calls, opinion polls, neighborhood gatherings, advisory panel
Has anyone has tried any of these?!

## Enlist Support9 endorsements

**"Touch-base" call between scheduled visits, calls from support group**
**Sponsor holiday party**
**If ill, send card and call to check on status**
**If family death/illness, send card from group or staff **

**Notes:**
Recognize that study staff don’t have all the answers or all the resources and can draw on participant assistance by asking for help with chain calls, opinion polls, neighborhood gatherings, advisory panel
Has anyone has tried any of these?!

## Other9 endorsements

**Send out surveys, reminder  letters prior to visit**
**Expectations clear at initial contact**
**Include feedback in next year's curriculum**
**Use scheduling and calendar software--visit window reports, prompts**
**Be alert and responsive to potential signs of drop out**
**Improve phone skills of callers**
**Check current student rosters**
**Cross-check roster for transferred students**
**Call patients the day before to remind them of their scheduled visit**

## Provide Opportunities for Flexibility 7 endorsements

**Truncate visit to include “primary” measures**
**Accommodate scheduling visits (off-site, phone)**
**Extend hours--early morning, evening, weekend**
**Leave message with toll free #, e-mail**
**Send CD-ROM lifestyle program**
**Schedule study visits around other appointments (increase convenience)**

**Notes:**
Seek ways to make special arrangements for visits

## Offer Instrumental Problem-Solving 4 endorsements 

**Offer home visit if house-bound**
**Offer phone/mail visit if moved **
**Suggest/help arrange carpools, babysitting**
**Money for transportation, parking, gasoline**

**Notes:**
If simple solution is beneficial, then help find way to make it happen 
Helping participant problem solve regarding babysitting arrangements, insurance paper work, etc...

## Practice Persistence 4 endorsements 

**Reschedule visits multiple times**
**Make multiple calls on different days**
**/times and weekends**
**Purchase a mail service that gives notice of non-delivery plus forwarding info when available**
**Record every call attempt to know when available;make notes if left message**

**Notes:**
Familiarity can be endearing, develop phone and mail contact strategies that are based on this principle 
Suggested intervention contact attempts is 3xs and suggested follow up visit contact attempts is 10-12xs
“You didn’t give up on me, so I didn’t give up on this program”

## Keep Boundaries 4 endorsements 

**During initial visit, ask for the best time to call and if OK to call them at work**
**Give "break" from contact/calls**
**Don't leave message at every call attempt!**
**Modify # of contacts, if perceived as too much of a burden**

**Notes:**
Establish acceptable boundaries of contact and be understanding
Even though OK to attempt call 8xs for an appointment, it may not be OK to leave a message every time!

## Exercise Patience3 endorsements

**Extend window if they have not received minimum # calls**
**Beg and plead **
**If injured or ill, reschedule when injury has healed  Modify  test if needed**

**Notes:**
Life changes and family situations may be chronic and not amenable to simple solutions

## Suggest Streamlining 2 endorsements 

**Negotiate to collect as much data as possible**
**Triage measures to collect the major outcome first, then collect other data as  tolerated by participant**

**Notes:**
Negotiate what portion of visit(s), intervention, contact type they are willing to do 
“I’ll come to clinic for follow up, but please don’t send me that questionnaire in the mail”

## Open Discussion

**Retention is something you work on before, during, and after the project**
**Retention can be affected by dynamic outside influences not controlled by the project design  **
**Strategies must be multi-faceted enough to deal with "real life” in a humane way**

## Controversial Issues

**Defining dropouts revisited **
**Broad versus narrow goals**
**Staff  time: effort versus burden **
**Modifying protocol adherence**
**Retention decisions and generalizability**
**Implications of retention decisions on data analyses**

## Next Steps.....

**Administer retention survey part 2 for frequency counts/rank orders by site**
**Analyze retention rates by rankings to see most helpful strategies for which groups**
**Explore how  to assess provider and institutional levels of retention and design studies to include attrition as part of the outcome**