Assessment of the Predictors and Moderators of Health Behavior Change

Health Behaviors Clinical Trial

— ABC3  

Official title:

Assessment of the Predictors and Moderators of Health Behavior Change

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03139656
• Other study ID #: 4345E
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: June 13, 2018

Study information

• Verified date: June 2018
• Source: Boston University Charles River Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: June 13, 2018
• Est. primary completion date: June 13, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Health Behaviors

Intervention

Behavioral:
• 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.
• 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.
• Combined
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.

Locations

Country	Name	City	State
United States	Boston University	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston University Charles River Campus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Goal Progress	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	Perceived Locus of Causality (PLOC)	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
Secondary	Positive and Negative Affect Schedule (PANAS)	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
Secondary	Goal Rating Measure	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
Secondary	Goal Orientation Scale	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
Secondary	Action Control Scale - Preoccupation subscale	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
Secondary	Distress Intolerance Index (DII)	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
Secondary	Penn State Worry Questionnaire--Brief Version	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
Secondary	Self-Control Scale	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
Secondary	Delay Discounting Task	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
Secondary	Need for Cognition Scale (Short Form)	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
Secondary	Cognitive Reflection Test (CRT)	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
Secondary	Implicit Attitudes toward Effort	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
Secondary	Satisfaction with Life Scale (SWLS)	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
Secondary	Center for Epidemiological Studies Depression Scale (CES-D)	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
Secondary	Beck Anxiety Inventory (BAI)	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
Secondary	Generalized Self-Efficacy Scale (GSE)	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
Secondary	Ruminative Responses Scale--Brief Version	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