NCT03139656

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 4, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2018

Completed
Last Updated

June 15, 2018

Status Verified

June 1, 2018

Enrollment Period

1.3 years

First QC Date

April 28, 2017

Last Update Submit

June 13, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (17)

  • Perceived Locus of Causality (PLOC)

    Change from baseline to 1-week and 4-week follow-ups

  • Positive and Negative Affect Schedule (PANAS)

    Change from baseline to 1-week and 4-week follow-ups

  • Goal Rating Measure

    Change from baseline to 1-week and 4-week follow-ups

  • Goal Orientation Scale

    Change from baseline to 1-week and 4-week follow-ups

  • Action Control Scale - Preoccupation subscale

    Change from baseline to 1-week and 4-week follow-ups

  • +12 more secondary outcomes

Study Arms (3)

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.

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.

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.

Behavioral: Combined

Interventions

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.

Values Clarification
PlanningBEHAVIORAL

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.

Planning
CombinedBEHAVIORAL

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.

Combined (Values Clarification & Planning)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston University

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

April 28, 2017

First Posted

May 4, 2017

Study Start

March 1, 2017

Primary Completion

June 13, 2018

Study Completion

June 13, 2018

Last Updated

June 15, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations