NCT05235360

Brief Summary

The objective of this study is to optimize a novel, audio-recorded physical activity intervention that is scalable. Using principles of the Multiphase Optimization Strategy (MOST) framework, a full factorial study will test the unique and combined effects of different intervention components to identify which combination of components is optimal for increasing physical activity and mechanisms by which the components are or are not effective. This information will inform decisions about an optimal intervention package that is effective, efficient, and minimizes participant burden.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2022

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 11, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

February 14, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

February 28, 2022

Status Verified

February 1, 2022

Enrollment Period

1.4 years

First QC Date

January 13, 2022

Last Update Submit

February 24, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Weekly Physical Activity Minutes Across 6 Weeks (accelerometer-assessed)

    Amount of weekly moderate-to-vigorous (MVPA) minutes (i.e., minutes of MPVA weighted by intensity) will be determined from accelerometers (ActiGraph wGT3X-BT) worn for one-week periods for six consecutive weeks.

    Assessed weekly at Weeks 1-6

Secondary Outcomes (1)

  • Change in Weekly Physical Activity Minutes Across 6 Weeks (self-reported)

    Assessed weekly at baseline and at Weeks 1-6

Other Outcomes (5)

  • Affective Response to Exercise

    Assessed weekly at baseline and at Weeks 1-6

  • Intrinsic Motivation for Exercise

    Assessed weekly at baseline and at Weeks 1-6

  • Delayed Discounting

    Assessed weekly at baseline and at Weeks 1-6

  • +2 more other outcomes

Study Arms (16)

Condition 1

EXPERIMENTAL

1\) Episodic future thinking; 2) Positive affect imagery; 3) Action planning; 4) High intervention dose

Behavioral: Episodic future thinkingBehavioral: Positive affect imageryBehavioral: Action planningBehavioral: High dose

Condition 2

EXPERIMENTAL

1\) Episodic future thinking; 2) Positive affect imagery; 3) Action planning; 4) Low intervention dose

Behavioral: Episodic future thinkingBehavioral: Positive affect imageryBehavioral: Action planningBehavioral: Low dose

Condition 3

EXPERIMENTAL

1\) Episodic future thinking; 2) Positive affect imagery; 3) High intervention dose

Behavioral: Episodic future thinkingBehavioral: Positive affect imageryBehavioral: High dose

Condition 4

EXPERIMENTAL

1\) Episodic future thinking; 2) Positive affect imagery; 3) Low intervention dose

Behavioral: Episodic future thinkingBehavioral: Positive affect imageryBehavioral: Low dose

Condition 5

EXPERIMENTAL

1\) Recent thinking; 2) Positive affect imagery; 3) Action planning; 4) High intervention dose

Behavioral: Positive affect imageryBehavioral: Action planningBehavioral: High doseBehavioral: Recent thinking

Condition 6

EXPERIMENTAL

1\) Recent thinking; 2) Positive affect imagery; 3) Action planning; 4) Low intervention dose

Behavioral: Positive affect imageryBehavioral: Action planningBehavioral: Recent thinkingBehavioral: Low dose

Condition 7

EXPERIMENTAL

1\) Recent thinking; 2) Positive affect imagery; 3) High intervention dose

Behavioral: Positive affect imageryBehavioral: High doseBehavioral: Recent thinking

Condition 8

EXPERIMENTAL

1\) Recent thinking; 2) Positive affect imagery; 3) Low intervention dose

Behavioral: Positive affect imageryBehavioral: Recent thinkingBehavioral: Low dose

Condition 9

EXPERIMENTAL

1\) Episodic future thinking; 2) Neutral imagery; 3) Action planning; 4) High intervention dose

Behavioral: Episodic future thinkingBehavioral: Action planningBehavioral: High doseBehavioral: Neutral imagery

Condition 10

EXPERIMENTAL

1\) Episodic future thinking; 2) Neutral imagery; 3) Action planning; 4) Low intervention dose

Behavioral: Episodic future thinkingBehavioral: Action planningBehavioral: Neutral imageryBehavioral: Low dose

Condition 11

EXPERIMENTAL

1\) Episodic future thinking; 2) Neutral imagery; 3) High intervention dose

Behavioral: Episodic future thinkingBehavioral: High doseBehavioral: Neutral imagery

Condition 12

EXPERIMENTAL

1\) Episodic future thinking; 2) Neutral imagery; 3) Low intervention dose

Behavioral: Episodic future thinkingBehavioral: Neutral imageryBehavioral: Low dose

Condition 13

EXPERIMENTAL

1\) Recent thinking; 2) Neutral imagery; 3) Action planning; 4) High intervention dose

Behavioral: Action planningBehavioral: High doseBehavioral: Recent thinkingBehavioral: Neutral imagery

Condition 14

EXPERIMENTAL

1\) Recent thinking; 2) Neutral imagery; 3) Action planning; 4) Low intervention dose

Behavioral: Action planningBehavioral: Recent thinkingBehavioral: Neutral imageryBehavioral: Low dose

Condition 15

EXPERIMENTAL

1\) Recent thinking; 2) Neutral imagery; 3) High intervention dose

Behavioral: High doseBehavioral: Recent thinkingBehavioral: Neutral imagery

Condition 16

EXPERIMENTAL

1\) Recent thinking; 2) Neutral imagery; 3) Low intervention dose

Behavioral: Recent thinkingBehavioral: Neutral imageryBehavioral: Low dose

Interventions

Participants will listen to a guided thinking task directing them to think about themselves at a future, positive event and to imagine the event in vivid and specific detail.

Condition 1Condition 10Condition 11Condition 12Condition 2Condition 3Condition 4Condition 9

Participants will listen to a guided thinking task directing them to think about positive feelings and associations about physical activity in specific, personal, and positive detail.

Condition 1Condition 2Condition 3Condition 4Condition 5Condition 6Condition 7Condition 8
Action planningBEHAVIORAL

Participants will listen to a guided thinking task directing them to think about the remainder of their week and when, where, and how they plan to attain their remaining activity for the week.

Condition 1Condition 10Condition 13Condition 14Condition 2Condition 5Condition 6Condition 9
High doseBEHAVIORAL

Participants will listen to the audio-recording with the guided thinking tasks 5 times/week.

Condition 1Condition 11Condition 13Condition 15Condition 3Condition 5Condition 7Condition 9
Recent thinkingBEHAVIORAL

Participants will listen to a guided thinking task directing them to think about a regular habit or activity they completed in the past week and to imagine that activity in specific and vivid detail.

Condition 13Condition 14Condition 15Condition 16Condition 5Condition 6Condition 7Condition 8
Neutral imageryBEHAVIORAL

Participants will listen to a guided thinking task directing them to imagine physical sensations (i.e., movements, muscles used) of a routine, daily activity (non-physical activity).

Condition 10Condition 11Condition 12Condition 13Condition 14Condition 15Condition 16Condition 9
Low doseBEHAVIORAL

Participants will listen to the audio-recording with the guided thinking tasks 1 time/week.

Condition 10Condition 12Condition 14Condition 16Condition 2Condition 4Condition 6Condition 8

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adults ages 18-64
  • Not currently meeting physical activity guidelines (\<150 minutes/week of self-reported moderate-to-vigorous physical activity)
  • Capable of providing informed consent
  • Access to a smartphone with active data plan
  • Willing to attend all study visits and comply with the protocol
  • Conversant in English

You may not qualify if:

  • BMI \> 40
  • orthopedic problems that would limit physical activity
  • self-reported coronary artery disease, stroke, COPD, chronic bronchitis, emphysema, diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southern Methodist University

Dallas, Texas, 75205, United States

RECRUITING

Related Publications (1)

  • Baldwin AS, Lamb CL, Geary BA, Mitchell AD, Kouros CD, Levens S, Martin LE. Testing and Optimizing Guided Thinking Tasks to Promote Physical Activity: Protocol for a Randomized Factorial Trial. JMIR Res Protoc. 2022 Sep 8;11(9):e40908. doi: 10.2196/40908.

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Contraceptives, Oral

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Contraceptive Agents, FemaleContraceptive AgentsReproductive Control AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesTherapeutic Uses

Study Officials

  • Austin S. Baldwin, PhD

    Southern Methodist University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Colin Lamb, BA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2022

First Posted

February 11, 2022

Study Start

February 14, 2022

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

February 28, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will share

De-identified data will be made available, in addition to the study protocol, statistical analysis plan, informed consent, and analytic code. Data will be made available to interested parties after all the initial study analyses and outcomes have been published.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Data will be made available one year after study completion.
Access Criteria
Researchers who provide a methodologically sound proposal and sign a data use agreement. Proposals should be submitted to Austin Baldwin.

Locations