Clinical Trials Directory

Trials / Completed

CompletedNCT03139656

Assessment of the Predictors and Moderators of Health Behavior Change

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
118 (actual)
Sponsor
Boston University Charles River Campus · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

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

Interventions

TypeNameDescription
BEHAVIORALValues 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.
BEHAVIORALPlanningParticipants 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.
BEHAVIORALCombinedParticipants 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.

Timeline

Start date
2017-03-01
Primary completion
2018-06-13
Completion
2018-06-13
First posted
2017-05-04
Last updated
2018-06-15

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03139656. Inclusion in this directory is not an endorsement.