Health BehaviorsABC3NCT03139656
Assessment of the Predictors and Moderators of Health Behavior Change
A study testing Values Clarification, Planning and Combined in people with Health Behaviors, run by Boston University Charles River Campus at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Behaviors
- What is being tested?
- Values Clarification, Planning and Combined
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 13 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Health Behaviors
- Being tested
- Values Clarification, Planning, Combined
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Values ClarificationBehavioural
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.
PlanningBehavioural
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.
CombinedBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Values Clarification | Experimental | 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. Receives: Behavioral: Values Clarification |
| Planning | Experimental | 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. Receives: Behavioral: Planning |
| Combined (Values Clarification & Planning) | Experimental | 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. Receives: Behavioral: Combined |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change from baseline to 1-week and 4-week follow-ups
Secondary outcomes (17)
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.
Measured: Change from baseline to 1-week and 4-week follow-ups
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.
Measured: Change from baseline to 1-week and 4-week follow-ups
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.
Measured: Change from baseline to 1-week and 4-week follow-ups
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).
Measured: Change from baseline to 1-week and 4-week follow-ups
Action Control Scale - Preoccupation subscale
This is an abbreviated version of the scale designed by Diefendorff et al. (2000).
Measured: Change from baseline to 1-week and 4-week follow-ups
Distress Intolerance Index (DII)
The DII is a 10-item self-report questionnaire consisting of items from four commonly used distress intolerance measures.
Measured: Change from baseline to 1-week and 4-week follow-ups
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.
Measured: Change from baseline to 1-week and 4-week follow-ups
Self-Control Scale
The SCS (Tangney et al., 2004) is a 10-item measure of ability to implement self-control across varying situations.
Measured: Change from baseline to 1-week and 4-week follow-ups
Delay Discounting Task
The Delay Discounting Task adapted from Kirby and Marakovic (1996) evaluates the degree to which participants are willing to delay rewards.
Measured: Change from baseline to 1-week and 4-week follow-ups
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.
Measured: Change from baseline to 1-week and 4-week follow-ups
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
Measured: Change from baseline to 1-week and 4-week follow-ups
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."
Measured: Change from baseline to 1-week and 4-week follow-ups
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.
Measured: Change from baseline to 1-week and 4-week follow-ups
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.
Measured: Change from baseline to 1-week and 4-week follow-ups
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.
Measured: Change from baseline to 1-week and 4-week follow-ups
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.
Measured: Change from baseline to 1-week and 4-week follow-ups
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.
Measured: Change from baseline to 1-week and 4-week follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start1 Mar 2017
- Primary completion13 Jun 2018
- Study completion13 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Otto, Boston University Charles River Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03139656
- Sponsor's protocol ID
- 4345E
- Acronym
- ABC3
- Status last verified
- Jun 2018
- First submitted
- 28 Apr 2017
- Last updated
- 15 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Predictors and Moderators of Health Behavior Change
- ClinicalTrials.gov ID
- NCT03139656
- Acronym / sponsor ID
- ABC3 / 4345E
- Conditions
- Health Behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 13 Jun 2018 (actual)
- Study completion
- 13 Jun 2018 (actual)
- First posted
- 4 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Values Clarification | Experimental | Behavioral: Values ClarificationThis 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 | Experimental | Behavioral: PlanningParticipants 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 (Values Clarification & Planning) | Experimental | Behavioral: CombinedParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Values ClarificationThis 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. | Behavioural | Values Clarification |
| PlanningParticipants 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. | Behavioural | Planning |
| CombinedParticipants 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. | Behavioural | Combined (Values Clarification & Planning) |
Primary outcome
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).
17 secondary outcomes
Perceived Locus of Causality (PLOC)
Time frame: 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
Goal Rating Measure
Time frame: 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
Action Control Scale - Preoccupation subscale
Time frame: 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
Penn State Worry Questionnaire--Brief Version
Time frame: 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
Delay Discounting Task
Time frame: 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
Cognitive Reflection Test (CRT)
Time frame: 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
Satisfaction with Life Scale (SWLS)
Time frame: 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
Beck Anxiety Inventory (BAI)
Time frame: 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
Ruminative Responses Scale--Brief Version
Time frame: Change from baseline to 1-week and 4-week follow-ups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Values Clarification, Planning and Combined in people with Health Behaviors, run by Boston University Charles River Campus at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goal Progress (time frame: Change from baseline to 1-week and 4-week follow-ups). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2018.