Evaluating Mechanisms of Action of Adaptive Goal-Setting for Physical Activity

NCT04505241 | Completed

• 1 other identifier: DRX-7861
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Behavior modification programs hold promise for increasing levels of physical activity (PA) for individuals who are insufficiently active. However, existing interventions, which typically prescribe uniform PA goals across participants, are limited by their insensitivity to changing individual needs and circumstances over time. An alternative approach is to continuously adjust goal difficulty to match fluctuations in individual performance, or adaptive goal-setting (AGS), which evidence suggests may more effective for increasing PA than non-adaptive approaches. Still, no prior studies have examined the psychological mechanisms targeted by AGS, which limits the ability to further refine and disseminate this technique. In this exploratory study, several candidate mechanisms of AGS (expectancy beliefs about goals, perceived value of goals, affective appraisal of goals, implicit attitudes towards exercise) will be examined. Adult participants interested in increasing their level of physical activity (N = 36) will be randomized to receive 6 weeks of either adaptive goal-setting (AGS) or non-adaptive, static goal-setting (SGS) as part of a remote, low-intensity PA intervention. The primary aim of the study will be to evaluate the hypothesis that AGS, as compared to SGS, results in greater increases over time to four hypothesized psychological mechanisms. The secondary aim will be to evaluate whether post-intervention increases to any among these three mechanisms mediate the relationship between intervention type (AGS vs. SGS) and increases to PA over the course of the intervention.

Conditions

Motivation; Physical Activity Promotion; Behavior Change; Mobile Health

Keywords

Physical Activity; Goal-Setting; Adaptive Interventions; Health-Related Behavior Change

Outcome Measures

Primary Outcomes (4)

• Change to Week 3 Expectancy Beliefs about Goals at Week 7

  Expectations about one's own ability to achieve physical activity goals will be assessed weekly using a single Likert scale derived from prior research on Expectancy-Values Theories (EVT) of achievement motivation. Responses on the scale will range from 1-5, with higher values representing higher expectations about one's ability to achieve daily activity goals.

  Measured once weekly from Week 3 through Week 7

• Change to Week 3 Affective Appraisals of Goals at Week 7

  Appraisals of daily physical activity goals will assessed weekly using a single Likert scale item asking participants to rate their emotional reactions to daily goals on a scale from 1 (Most Negative) to 10 (Most Positive).

  Measured once weekly from Week 3 through Week 7

• Change to Week 3 Perceived Value of Goals at Week 7

  Perceived Value of Goals corresponds to the value or importance that an individual attributes to assigned activity goals, and will be assessed weekly using four items derived from Expectancy-Value Theory (EVT) questionnaires (attainment value; interest value; utility value; cost). All items will be measured on a 1-5 Likert scale where higher scores represent higher perceived value, and the mean of all four items will be used to generate an overall Perceived Value score.

  Measured once weekly from Week 3 through Week 7

• Change to Baseline Implicit Attitudes Towards Exercise at Week 8

  Implicit attitudes towards exercise will be measured using an Implicit Association Test (IAT) tailored to examine attitudes towards exercise. Image and text stimuli will be closely adapted from prior IAT research in the domain of exercise, with "Exercise" vs. "Not Exercise" serving as the concept dimension and "Pleasant" vs. "Unpleasant" serving as the attribute dimension. A difference score (d-score) will be computed for each participant, with more positive scores indicating more favorable implicit attitudes towards exercise.

  Measured at Week 0 (baseline) and Week 8 (post-intervention)

Secondary Outcomes (4)

• Change to Baseline Self-efficacy for Exercise at Week 8

  Measured at Week 0 (baseline) and Week 8 (post-intervention)

• Change to Baseline Physical Activity Enjoyment at Week 8

  Measured at Week 0 (baseline) and Week 8 (post-intervention)

• Change to Autonomous Motivation to Exercise at Week 8

  Measured at Week 0 (baseline) and Week 8 (post-intervention)

• Change to Baseline Daily Levels of Physical Activity at Week 8

  Measured at Week 0 (baseline) and Week 8 (post-intervention)

Study Arms (2)

Adaptive Goal-Setting

EXPERIMENTAL

Participants in this condition will receive daily step goals calculated as the 60th percentile of their last 9 days of available daily steps data. Goals will be transmitted over text message, and will be accompanied by information about the participant's steps on the previous day and whether they met their goal the previous day.

Behavioral: Remotely-delivered physical activity promotion

Static Goal-Setting

EXPERIMENTAL

Participants in this condition will receive daily a uniform daily goal of 10,000 steps per day. Participants will receive daily texts including information about the participant's steps on the previous day, whether they met their goal the previous day, and encouraging them to continue striving for 10,000 steps each day.

Behavioral: Remotely-delivered physical activity promotion

Interventions

Remotely-delivered physical activity promotion BEHAVIORAL

Over video-call, participants will receive educational content on safely increasing their levels of physical activity (e.g., selecting an appropriate form of exercise, minimizing health risks, the importance of planning), will receive daily text messages (see arm descriptions) for six weeks and complete a 10-15 minute check-in call at the 3-week point of the intervention to assess compliance with daily step goals as well as to help problem-solve barriers to compliance.

Adaptive Goal-Setting; Static Goal-Setting

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-75 years old
• Reporting a desire to increase physical activity in order to lose weight, prevent weight gain or improve physical health
• Possessing a smartphone that can connect to a WiFi (wireless fidelity) network
• Daily access to a WiFi connection
• Ability to understand and provide informed consent
• Proficiency in speaking, reading, and writing English
• Currently report engaging in insufficient levels of physical activity (\<150 minutes/week of moderate-to-vigorous physical activity)

You may not qualify if:

• Present involvement in another physical activity promotion or a behavioral weight loss program
• Pregnant or planning to become pregnant within the next 6 months (exclude for either)
• Current BMI \<18.5 kg/m\^2
• Diagnosis of a medical condition that could limit the ability to increase physical activity
• Acute suicide risk (exclude if present in the past 2 weeks or if any attempts were made in past 2 years)
• Current substance use disorder
• Current diagnosis of psychosis
• Current diagnosis of bipolar disorder
• Currently meet criteria for loss-of-control eating
• Presence of compensatory behaviors (vomiting, laxatives, diuretics, exercise)

Sponsors & Collaborators

• Drexel University: lead

Study Sites (1)

Drexel University

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants will not be informed of their assigned condition, though may infer it through the types of texts that they receive. The principal investigator and outcomes assessor will each be blinded to a participant's assignment while the participant is enrolled in the study, and will be unblinded at the conclusion of the study prior to performing statistical analyses.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Model Details: Half of participants will be randomized to receive text message-delivered adaptive goal-setting (goals change each day) for 6 weeks, and half will receive static goal-setting (goals are fixed) for 6 weeks.

Study Record Dates

• First Submitted: August 2, 2020
• First Posted: August 10, 2020
• Study Start: September 21, 2020
• Primary Completion: February 1, 2021
• Study Completion: April 1, 2021
• Last Updated: April 13, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)