Physical ActivityNCT05582369
Feel the Move: A Micro-Randomized Trial of a Text-Based Expectation-Setting Intervention to Increase Physical Activity
A study testing Affective Rewards Messages in people with Physical Activity, run by University of Michigan at 1 site in United States.
Trial summary
The aim of this research is to evaluate the impacts of an intervention that reminds people of the affective rewards of exercise on physical activity in adults of any activity level Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Affective Rewards Messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2023to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- lives in the US
- 18 years old or older
- desires to increase activity through structured exercise
- has an iPhone that can send/receive text messages and an Apple Watch
Who cannot join
- medically advised not to exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Setting Expectations for Enjoyment of Physical Activity
The aim of this research is to evaluate the impacts of an intervention that reminds people of the affective rewards of exercise on physical activity in adults of any activity level
Read the detailed description
The Feel the Move study tests the effects of a lightweight text-message based intervention to increase physical activity and affective attitudes towards exercise. The intervention being investigated is text messages that prime expected affective rewards of exercise, sent in advance of a time window during which participants made plans to exercise. At the start of the study, participants will write sentences about feeling good after exercise (which will be used as part of the intervention) and complete baseline questionnaires about their feelings towards exercise. For the next nine weeks, participants will be asked to plan two exercise sessions a week, and will be given a questionnaire after the time window of their planned exercise sessions to assess how it went. At the onset of each time window for their planned exercise session, participants will be micro-randomized to receive one of the following intervention options: no-message; a text message reminding them to fill out the study questionnaires; or a message about the affective rewards of exercise. The messages about affective rewards will be a mix of sentences participants wrote themselves during the baseline assessment and reflective prompts from the research team. At the nine-week mark, participants will again complete the same questionnaires about their feelings towards exercise that they initially completed at baseline. Throughout the study, participants will share data about their activity, including steps and calories burned, with the research team. These data will be automatically collected by the HIPAA-compliant CareEvolution platform from participants' Apple Watches. After the nine weeks of the study participation, a random sample of study participants will be asked to participate in exit interviews to share more details about their experiences with the intervention.
The primary hypothesis is that participants will burn more calories during their planned exercise periods when they receive messages about the affective rewards of exercise vs. when they do not. Researchers will also conduct secondary analyses examining the effects of the intervention on feelings towards exercise and qualitative data from the interviews.
- Conditions
- Physical Activity
- Being tested
- Affective Rewards Messages
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Affective Rewards MessagesBehavioural
Messages about the affective rewards of exercise
| Study group | Role | What they receive |
|---|---|---|
| Affective Rewards Messages | Experimental | Throughout the study, each week participants will be asked to plan two exercise sessions for the upcoming week, and will be asked to report on how they did with those plans at the end of the day when they planned to exercise. At the very beginning of the time window when they planned to exercise participants will be randomized with 40% probability to receive no message, 20% probability to receive a reminder to fill out the study questionnaire at the end of the day, and 40% probability to receive one of two types of affective rewards messages (active intervention). The two types are: 1) low-reflection messages written by participants at the beginning of the study, about the affective rewards of exercise they have previously experienced; and 2) high-reflection messages that prompt participants to reflect on the affective rewards of exercise and text back a response. Receives: Behavioral: Affective Rewards Messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calories burned in planned exercise session
Calories burned during the four-hour time window when participants planned to exercise
Measured: 4 hours
Secondary outcomes (2)
Change from Baseline Expected Post-exercise affect at 9 weeks
Participants will be asked question about their expected post-exercise affect at the beginning and end of the 9 week study
Measured: At study completion, 9 weeks after enrollment
Change from Baseline in other affective attitude measures at 9 weeks
Participants will be asked additional questions about their affective attitudes towards and valuations of exercise at the beginning and end of the 9 week study
Measured: At study completion, 9 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start31 May 2023
- Primary completion1 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- At each decision point-operationalized as the beginning of the time window during which a participant planned to exercise-each participant will be randomized to receive one of three intervention options: active intervention (text messages aimed to prime expectations of emotional rewards of exercise), a control message (a reminder that they will receive a study questionnaire later in the day), or no intervention.
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedja Klasnja, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05582369
- Sponsor's protocol ID
- HUM00190301
- Status last verified
- Jun 2024
- First submitted
- 21 Sep 2022
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mishra SR, Dempsey W, Klasnja P. A Text Messaging Intervention for Priming the Affective Rewards of Exercise in Adults: Protocol for a Microrandomized Trial. JMIR Res Protoc. 2023 Sep 1;12:e46560. doi: 10.2196/46560.
PubMed 37656493
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Setting Expectations for Enjoyment of Physical Activity
- ClinicalTrials.gov ID
- NCT05582369
- Acronym / sponsor ID
- HUM00190301
- Conditions
- Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 31 May 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 17 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this research is to evaluate the impacts of an intervention that reminds people of the affective rewards of exercise on physical activity in adults of any activity level
Detailed description
The Feel the Move study tests the effects of a lightweight text-message based intervention to increase physical activity and affective attitudes towards exercise. The intervention being investigated is text messages that prime expected affective rewards of exercise, sent in advance of a time window during which participants made plans to exercise. At the start of the study, participants will write sentences about feeling good after exercise (which will be used as part of the intervention) and complete baseline questionnaires about their feelings towards exercise. For the next nine weeks, participants will be asked to plan two exercise sessions a week, and will be given a questionnaire after the time window of their planned exercise sessions to assess how it went. At the onset of each time window for their planned exercise session, participants will be micro-randomized to receive one of the following intervention options: no-message; a text message reminding them to fill out the study questionnaires; or a message about the affective rewards of exercise. The messages about affective rewards will be a mix of sentences participants wrote themselves during the baseline assessment and reflective prompts from the research team. At the nine-week mark, participants will again complete the same questionnaires about their feelings towards exercise that they initially completed at baseline. Throughout the study, participants will share data about their activity, including steps and calories burned, with the research team. These data will be automatically collected by the HIPAA-compliant CareEvolution platform from participants' Apple Watches. After the nine weeks of the study participation, a random sample of study participants will be asked to participate in exit interviews to share more details about their experiences with the intervention.
The primary hypothesis is that participants will burn more calories during their planned exercise periods when they receive messages about the affective rewards of exercise vs. when they do not. Researchers will also conduct secondary analyses examining the effects of the intervention on feelings towards exercise and qualitative data from the interviews.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- At each decision point-operationalized as the beginning of the time window during which a participant planned to exercise-each participant will be randomized to receive one of three intervention options: active intervention (text messages aimed to prime expectations of emotional rewards of exercise), a control message (a reminder that they will receive a study questionnaire later in the day), or no intervention.
| Arm | Type | Receives |
|---|---|---|
| Affective Rewards Messages | Experimental | Behavioral: Affective Rewards MessagesThroughout the study, each week participants will be asked to plan two exercise sessions for the upcoming week, and will be asked to report on how they did with those plans at the end of the day when they planned to exercise. At the very beginning of the time window when they planned to exercise participants will be randomized with 40% probability to receive no message, 20% probability to receive a reminder to fill out the study questionnaire at the end of the day, and 40% probability to receive one of two types of affective rewards messages (active intervention). The two types are: 1) low-reflection messages written by participants at the beginning of the study, about the affective rewards of exercise they have previously experienced; and 2) high-reflection messages that prompt participants to reflect on the affective rewards of exercise and text back a response. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- lives in the US
- 18 years old or older
- desires to increase activity through structured exercise
- has an iPhone that can send/receive text messages and an Apple Watch
Key exclusion criteria (1 listed)
- medically advised not to exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Affective Rewards MessagesMessages about the affective rewards of exercise | Behavioural | Affective Rewards Messages |
Primary outcome
Calories burned in planned exercise session
Time frame: 4 hours
Calories burned during the four-hour time window when participants planned to exercise
2 secondary outcomes
Change from Baseline Expected Post-exercise affect at 9 weeks
Time frame: At study completion, 9 weeks after enrollment
Change from Baseline in other affective attitude measures at 9 weeks
Time frame: At study completion, 9 weeks after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Derived from this study: PubMed 37656493Mishra SR, Dempsey W, Klasnja P. A Text Messaging Intervention for Priming the Affective Rewards of Exercise in Adults: Protocol for a Microrandomized Trial. JMIR Res Protoc. 2023 Sep 1;12:e46560. doi: 10.2196/46560.
- Individual participant dataSharing planned: No
Related trials for Physical Activity
Recruiting
Effectivity of P1821, a Novel Tongue Strengthening and Endurance Enhancing Speech Flow Exercise
Ankyloglossia, Impairment of Speech
RecruitingPhase 1
A Study to Evaluate the Safety and Antitumor Activity of GS-1206 in Adults With Solid Tumors
Solid Tumor
Recruiting
Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
Fecal Incontinence
RecruitingPhase 2/3
The Effect of Additive On-Demand Sildenafil vs. Dextrose Candy on Maximum Exercise Capacity in Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)
RecruitingEarly Phase 1
Real-Time Atherosclerosis Activity After Thoracic Radiotherapy Using Sodium Fluoride Positron Emission Tomography
Oligometastatic Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Affective Rewards Messages in people with Physical Activity, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calories burned in planned exercise session (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05582369, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.