Assessment of the Predictors and Moderators of Health Behavior Change (ABC3)

June 13, 2018 updated by: Michael Otto, Boston University Charles River Campus

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

Detailed Description

The study will be a repeated measures design examining the between-subjects effect of intervention condition (values clarification, planning, and combined) on self-reported health goal progress and related outcomes at 1-week and 4-week follow-up, relative to baseline. Based on this design, participants will first be instructed to generate a health-related goal on which they want to make progress over the course of the next month (following procedures adapted from Little, 1993, and Sheldon & Kasser, 1998; see details below). Participants will then be randomly assigned (using a random number table) to one of three intervention conditions: (1) values clarification, (2) planning, and (3) combined (values clarification + planning). All conditions are described in more detail below. Fifty-three participants will be randomized to each condition. Questionnaire measures assessing a variety of psychological variables as well as neuropsychological measures will be modeled as between-subject predictor and/or moderator variables of goal-consistent health behavior. Additionally, differences in self-concordance, goal commitment, and expectancies of success will be modeled as potential moderator and/or mediator variables.

Study Type

Interventional

Enrollment (Actual)

118

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Boston University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

June 13, 2018

Study Completion (Actual)

June 13, 2018

Study Registration Dates

First Submitted

April 28, 2017

First Submitted That Met QC Criteria

May 1, 2017

First Posted (Actual)

May 4, 2017

Study Record Updates

Last Update Posted (Actual)

June 15, 2018

Last Update Submitted That Met QC Criteria

June 13, 2018

Last Verified

June 1, 2018

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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