Clinical trial NCT03139656: Assessment of the Predictors and Moderators of Health Behavior Change
Official title: Assessment of the Predictors and Moderators of Health Behavior Change
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behaviors
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
First posted: 2017-05-04
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Goal Progress
timeFrame: Change from baseline to 1-week and 4-week follow-ups
Secondary outcomes:
measure: Perceived Locus of Causality (PLOC)
timeFrame: Change from baseline to 1-week and 4-week follow-ups
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Change from baseline to 1-week and 4-week follow-ups
measure: Goal Rating Measure
timeFrame: Change from baseline to 1-week and 4-week follow-ups
measure: Goal Orientation Scale
timeFrame: Change from baseline to 1-week and 4-week follow-ups
measure: Action Control Scale - Preoccupation subscale
timeFrame: Change from baseline to 1-week and 4-week follow-ups
measure: Distress Intolerance Index (DII)
timeFrame: Change from baseline to 1-week and 4-week follow-ups
measure: Penn State Worry Questionnaire--Brief Version
timeFrame: Change from baseline to 1-week and 4-week follow-ups
measure: Self-Control Scale
timeFrame: Change from baseline to 1-week and 4-week follow-ups
measure: Delay Discounting Task
timeFrame: Change from baseline to 1-week and 4-week follow-ups
measure: Need for Cognition Scale (Short Form)
timeFrame: Change from baseline to 1-week and 4-week follow-ups
measure: Cognitive Reflection Test (CRT)
timeFrame: Change from baseline to 1-week and 4-week follow-ups
measure: Implicit Attitudes toward Effort
timeFrame: Change from baseline to 1-week and 4-week follow-ups
measure: Satisfaction with Life Scale (SWLS)
timeFrame: Change from baseline to 1-week and 4-week follow-ups
measure: Center for Epidemiological Studies Depression Scale (CES-D)
timeFrame: Change from baseline to 1-week and 4-week follow-ups
measure: Beck Anxiety Inventory (BAI)
timeFrame: Change from baseline to 1-week and 4-week follow-ups
measure: Generalized Self-Efficacy Scale (GSE)
timeFrame: Change from baseline to 1-week and 4-week follow-ups
measure: Ruminative Responses Scale--Brief Version
timeFrame: Change from baseline to 1-week and 4-week follow-ups
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University
state: Massachusetts
Study officials:
References: