- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03139656
Assessment of the Predictors and Moderators of Health Behavior Change (ABC3)
This study will investigate three interventions-values clarification, planning, or combined (values clarification + planning)-for increasing goal-consistent health behavior (e.g., exercise or dieting). The investigators will also examine how intervention effects differ based on various psychological and neuropsychological factors, to better understand how interventions can be tailored to specific individuals.
The investigators hypothesize a) that the combined intervention will increase goal-consistent exercise behavior more than the other interventions; and b) that individuals scoring higher on self-concordance or goal-commitment will benefit more from planning, whereas those with more positive expectancies or scoring higher on neuropsychological measures (e.g., working memory) will benefit more from values clarification.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Boston University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Boston University Psychology 101 students at least 18 years of age
- Able to provide informed consent for the study
- Sufficient command of the English language
- Have experience using a computer and mouse
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Values Clarification
This intervention will incorporate elements from several widely established self-regulatory strategies aimed at enhancing the motivational aspects of goal pursuit, including mental contrasting (Oettingen, 2000), self-reflection (Koestner et al., 2002), self-affirmation (Schmeichel and Vohs, 2009), and the values clarification components of Acceptance and Commitment Therapy (ACT; Hayes, Strosahl, & Wilson, 1999).
Participants will be prompted to enter their selected health goal and will then be instructed to identify personal values that might be practiced in pursuit of this goal.
Participants will write about these values for several minutes, after which they will be instructed to select a short phrase or image that conjures up for them the reasons they choose to engage in their goal.
Participants will be asked to type the phrase into a textbox and will have the option of receiving a confidential print-out of their chosen phrase at the end of the study visit.
|
This intervention will incorporate elements from several widely established self-regulatory strategies aimed at enhancing the motivational aspects of goal pursuit, including mental contrasting (Oettingen, 2000), self-reflection (Koestner et al., 2002), self-affirmation (Schmeichel and Vohs, 2009), and the values clarification components of Acceptance and Commitment Therapy (ACT; Hayes, Strosahl, & Wilson, 1999).
Participants will be prompted to enter their selected health goal and will then be instructed to identify personal values that might be practiced in pursuit of this goal.
Participants will write about these values for several minutes, after which they will be instructed to select a short phrase or image that conjures up for them the reasons they choose to engage in their goal.
Participants will be asked to type the phrase into a textbox and will have the option of receiving a confidential print-out of their chosen phrase at the end of the study visit.
|
Experimental: Planning
Participants in this condition will be guided to create detailed implementation intentions, or if-then planning statements (Gollwitzer & Sheeran, 2006), specifying when, how, and where they will engage in their selected health goal.
Participants will be provided with a detailed rationale adapted from earlier research on implementation intentions (e.g., Webb et al., 2010).
Participants will be guided to generate a plan indicating when, where, and how they will enact their goal-based behavior over the next week.
They will also be prompted to identify 3 obstacles they are likely to encounter during the pursuit of each goal, and to specify in an "if-then" format what specific actions they will take to overcome each obstacle (following the procedures and sample "if-then" responses of Koestner et al., 2002).
They will be asked to rehearse each "if-then" statement to themselves before the end of the visit.
|
Participants in this condition will be guided to create detailed implementation intentions, or if-then planning statements (Gollwitzer & Sheeran, 2006), specifying when, how, and where they will engage in their selected health goal.
Participants will be provided with a detailed rationale adapted from earlier research on implementation intentions (e.g., Webb et al., 2010).
Participants will be guided to generate a plan indicating when, where, and how they will enact their goal-based behavior over the next week.
They will also be prompted to identify 3 obstacles they are likely to encounter during the pursuit of each goal, and to specify in an "if-then" format what specific actions they will take to overcome each obstacle (following the procedures and sample "if-then" responses of Koestner et al., 2002).
They will be asked to rehearse each "if-then" statement to themselves before the end of the visit.
|
Experimental: Combined (Values Clarification & Planning)
Participants in this condition will complete abbreviated versions of both the "values clarification" and "planning" procedures, as detailed above.
Participants will be prompted to identify 2 obstacles (as opposed to 3) they might encounter during the pursuit of each goal.
For each of the obstacles they identify with respect to each of their target goals, they will be prompted to form an additional implementation intention in the form: "When [I encounter the specified obstacle], I will do [X] and remember [values-based statement or image identified during "values clarification" exercise]."
They will be asked to rehearse these "if-then" statements to themselves before the end of the visit.
|
Participants in this condition will complete abbreviated versions of both the "values clarification" and "planning" procedures, as detailed above.
Participants will be prompted to identify 2 obstacles (as opposed to 3) they might encounter during the pursuit of each goal.
For each of the obstacles they identify with respect to each of their target goals, they will be prompted to form an additional implementation intention in the form: "When [I encounter the specified obstacle], I will do [X] and remember [values-based statement or image identified during "values clarification" exercise].
They will be asked to rehearse these "if-then" statements to themselves before the end of the visit.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Goal Progress
Time Frame: Change from baseline to 1-week and 4-week follow-ups
|
This 3-item goal progress measure assesses participants' self-reported effort towards and success at meeting their specified goal over the past week, each on a 7-point Likert scale.
The third item assesses the number of actions participants have undertaken to realize their goal in the past week (previously shown to be a valid indicator of goal pursuit; Oettingen et al., 2001; Sevincer & Oettingen, 2009).
|
Change from baseline to 1-week and 4-week follow-ups
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived Locus of Causality (PLOC)
Time Frame: Change from baseline to 1-week and 4-week follow-ups
|
The PLOC scale (Sheldon & Kasser, 1995, 1998) is a 4-item measure of the level of autonomy or self-concordance that participants experience with respect to a given goal.
|
Change from baseline to 1-week and 4-week follow-ups
|
Positive and Negative Affect Schedule (PANAS)
Time Frame: Change from baseline to 1-week and 4-week follow-ups
|
Participants rate 20 adjectives describing positive and negative affect states on a 5-point Likert scale indicating to what extent they currently feel that way.
|
Change from baseline to 1-week and 4-week follow-ups
|
Goal Rating Measure
Time Frame: Change from baseline to 1-week and 4-week follow-ups
|
On a 7-point Likert scale, participants will rate their health-related goal regarding their expectancies of success, their energization towards the goal, and the perceived difficult and importance of the goal.
|
Change from baseline to 1-week and 4-week follow-ups
|
Goal Orientation Scale
Time Frame: Change from baseline to 1-week and 4-week follow-ups
|
This is a 5-item scale that assesses participant's orientation toward a growth/learning-focused versus fixed/performance-focused motivation, adapted from Brett and VandeWalle (1999).
|
Change from baseline to 1-week and 4-week follow-ups
|
Action Control Scale - Preoccupation subscale
Time Frame: Change from baseline to 1-week and 4-week follow-ups
|
This is an abbreviated version of the scale designed by Diefendorff et al. (2000).
|
Change from baseline to 1-week and 4-week follow-ups
|
Distress Intolerance Index (DII)
Time Frame: Change from baseline to 1-week and 4-week follow-ups
|
The DII is a 10-item self-report questionnaire consisting of items from four commonly used distress intolerance measures.
|
Change from baseline to 1-week and 4-week follow-ups
|
Penn State Worry Questionnaire--Brief Version
Time Frame: Change from baseline to 1-week and 4-week follow-ups
|
The Brief Penn State Worry Questionnaire (Brief PSWQ;Topper et al., 2014) is a 5-item self-report scale that assess the tendency to worry.
|
Change from baseline to 1-week and 4-week follow-ups
|
Self-Control Scale
Time Frame: Change from baseline to 1-week and 4-week follow-ups
|
The SCS (Tangney et al., 2004) is a 10-item measure of ability to implement self-control across varying situations.
|
Change from baseline to 1-week and 4-week follow-ups
|
Delay Discounting Task
Time Frame: Change from baseline to 1-week and 4-week follow-ups
|
The Delay Discounting Task adapted from Kirby and Marakovic (1996) evaluates the degree to which participants are willing to delay rewards.
|
Change from baseline to 1-week and 4-week follow-ups
|
Need for Cognition Scale (Short Form)
Time Frame: Change from baseline to 1-week and 4-week follow-ups
|
The NCS-SF (Cacioppo, Petty, & Kao, 1984) is an 18-item scale that assesses the characteristic tendency to enjoy and seek out cognitively challenging tasks and activities.
|
Change from baseline to 1-week and 4-week follow-ups
|
Cognitive Reflection Test (CRT)
Time Frame: Change from baseline to 1-week and 4-week follow-ups
|
The CRT (Frederick, 2005) is a 3-item task that assesses the tendency to use "fast," intuitive heuristic-based reasoning versus "slow," more deliberative reasoning
|
Change from baseline to 1-week and 4-week follow-ups
|
Implicit Attitudes toward Effort
Time Frame: Change from baseline to 1-week and 4-week follow-ups
|
The investigators will use an adapted version of the Brief Implicit Association Test (B-IAT; Sriram & Greenwald, 1998) to assess participants' implicit tendency to appraise the experience of effort as either "good" or "bad."
|
Change from baseline to 1-week and 4-week follow-ups
|
Satisfaction with Life Scale (SWLS)
Time Frame: Change from baseline to 1-week and 4-week follow-ups
|
The SWLS (Diner, Emmons, Larsen, & Griffin, 1985) is a 5-item scale assessing global cognitive judgments of one's current life satisfaction.
|
Change from baseline to 1-week and 4-week follow-ups
|
Center for Epidemiological Studies Depression Scale (CES-D)
Time Frame: Change from baseline to 1-week and 4-week follow-ups
|
The CES-D (Radloff, 1977) is a 20-item measure of items relating to or indicating symptoms of depression experienced over the past week.
|
Change from baseline to 1-week and 4-week follow-ups
|
Beck Anxiety Inventory (BAI)
Time Frame: Change from baseline to 1-week and 4-week follow-ups
|
The BAI (Beck, Epstein, Brown, & Steer, 1988) is a commonly used 21-item, self-report inventory designed to measure severity of anxiety symptoms.
|
Change from baseline to 1-week and 4-week follow-ups
|
Generalized Self-Efficacy Scale (GSE)
Time Frame: Change from baseline to 1-week and 4-week follow-ups
|
The GSE (Schwarzer & Jerusalem, 1995) is a 10-item scale designed to assess optimistic self-beliefs used to cope with a variety of demands in life.
|
Change from baseline to 1-week and 4-week follow-ups
|
Ruminative Responses Scale--Brief Version
Time Frame: Change from baseline to 1-week and 4-week follow-ups
|
The Brief Ruminative Responses Scale (Brief RRS; Topper et al., 2014) is a 5-item self-report scale that assess the tendency to ruminate.
|
Change from baseline to 1-week and 4-week follow-ups
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 4345E
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Health Behaviors
-
Istanbul University - Cerrahpasa (IUC)CompletedHealth Risk Behaviors | Reproductive Health | Sexual HealthTurkey
-
Pennington Biomedical Research CenterRecruitingHealth Behaviors | Development of Health ProblemsUnited States
-
Laura RichardsonCompleted
-
University of California, Los AngelesCompleted
-
Taipei Medical University WanFang HospitalTaipei Medical University Shuang Ho HospitalCompleted
-
Edith Cowan UniversityFlinders University; The University of Western AustraliaNot yet recruitingHealth Risk Behaviors
-
Denver Health and Hospital AuthorityAdvancing Care Together; Colorado Health FoundationCompletedPatient Health BehaviorsUnited States
-
University of California, BerkeleyUnited States Agency for International Development (USAID); French Development...UnknownHealth Insurance Sale | Health Utilization | Asset Sales, Investment and Saving BehaviorsCambodia
-
Edith Cowan UniversityFlinders University; The University of Western AustraliaCompleted
Clinical Trials on Values Clarification
-
University of UtahAmerican Heart AssociationRecruitingCongenital Heart Disease | Congenital Heart Defect | Patient Decision AidsUnited States
-
Universidade do PortoGeorgetown University; NOVA Medical SchoolUnknown
-
Mississippi State UniversityRecruiting
-
Mississippi State UniversityAssociation for contextual behavioral scienceNot yet recruitingHealth-Related BehaviorUnited States
-
Ibis Reproductive HealthMarie Stopes International; Marie Stopes EthiopiaCompleted
-
Shared Decision Making ResourcesEdwards LifesciencesCompletedAortic Stenosis SymptomaticUnited States
-
Akdeniz UniversityKoç UniversityRecruiting
-
University of Colorado, DenverNational Heart, Lung, and Blood Institute (NHLBI); Kaiser Permanente; University... and other collaboratorsCompletedHypertensionUnited States
-
University of Colorado, DenverAmerican Heart Association; Denver Health and Hospital Authority; University... and other collaboratorsCompletedHypertensionUnited States
-
The Hospital for Sick ChildrenCompleted