Overweight and ObesityNCT03465800
Understanding Mechanisms of Exercise Behavior Change
A study testing self-monitoring, daily incentives and delayed lump sum incentives in people with Overweight and Obesity and Physical Activity, run by University of Colorado, Boulder at 1 site in United States.
Trial summary
This research seeks to examine psychological factors that may impact relationship between incentives and health behavior engagement, specifically physical activity. Additionally, it will compare the impact of two different incentive schedules on behavior engagement, one providing immediate rewards (i.e. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Physical Activity, Incentives
- What is being tested?
- self-monitoring, daily incentives and delayed lump sum incentives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2018to 11 Jul 2018
- 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
- Complete less than 150 minutes of moderate-vigorous physical activity weekly
- Daily access to the internet for 3 weeks following baseline research visit
- Have or are willing to create an account on PayPal
- Willing to wear a heart rate monitor watch during physical activity for 3 weeks
- BMI greater than or equal to 25, from self-reported height and weight
Who cannot join
- Diagnosis of cardiovascular, metabolic, or renal disease
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Boulder
Boulder, Colorado, 80309
About this study
This research seeks to examine psychological factors that may impact relationship between incentives and health behavior engagement, specifically physical activity. Additionally, it will compare the impact of two different incentive schedules on behavior engagement, one providing immediate rewards (i.e. rewards received on a daily basis) and another providing delayed rewards (i.e. rewards received at the end of the study period), with an active self-monitoring intervention condition in which no rewards are offered. Study participants will provide reports of their physical activity each day for three weeks, and in the two incentive conditions, they will receive small monetary rewards for their physical activity. Following the three week reporting and reward period, participants will complete two additional assessments, measuring psychological constructs and behavior engagement following the cessation of rewards. The study will also examine how cognitive and anthropomorphic factors may contribute to intervention response and the effects on psychological constructs.
- Conditions
- Overweight and Obesity, Physical Activity, Incentives
- Being tested
- self-monitoring, daily incentives, delayed lump sum incentives
- Keywords
- overweight, obesity, physical activity, exercise
- Medical subject headings
- Overweight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-monitoringBehavioural
self-monitoring of physical activity
daily incentivesBehavioural
daily incentive payments for physical activity
delayed lump sum incentivesBehavioural
delayed lump sum payments for physical activity
| Study group | Role | What they receive |
|---|---|---|
| Self-Monitoring | Active comparator | Participants self-monitor their physical activity Receives: Behavioral: self-monitoring |
| Daily Incentives | Experimental | daily payments for physical activity Receives: Behavioral: self-monitoring; Behavioral: daily incentives |
| Delayed Lump Sum Incentives | Experimental | lump sum payments for physical activity Receives: Behavioral: self-monitoring; Behavioral: delayed lump sum incentives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Moderate-vigorous physical activity minutes
summed minutes of weekly moderate intensity physical activity \& vigorous intensity physical activity
Measured: Week 3
Self-Efficacy for physical activity
8-item self-report scale measuring self-efficacy (Social Cognitive Theory, Bandura, 1977; also called "perceived behavioral control", Theory of Planned Behavior, Ajzen, 1985); scores are a mean of 8 items, scored 1-7 with higher scores indicative of greater self-efficacy
Measured: Week 3
Moderate-vigorous physical activity minutes
summed minutes of weekly moderate intensity physical activity \& vigorous intensity physical activity
Measured: Week 5
Self-Efficacy for physical activity
8-item self-report scale measuring self-efficacy (Social Cognitive Theory, Bandura, 1977; also called "perceived behavioral control", Theory of Planned Behavior, Ajzen, 1985); scores are a mean of 8 items, scored 1-7 with higher scores indicative of greater self-efficacy
Measured: Week 5
Attitudes toward physical activity
12-item self-report scale (Theory of Planned Behavior, Ajzen, 1985); scores are a mean of 12 items scored from -5 to +5, with higher scores indicative of more positive attitudes
Measured: Week 3
Attitudes toward physical activity
12-item self-report scale (Theory of Planned Behavior, Ajzen, 1985); scores are a mean of 12 items scored from -5 to +5, with higher scores indicative of more positive attitudes
Measured: Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start26 Feb 2018
- Primary completion30 Jun 2018
- Study completion11 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Bryan, University of Colorado, Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03465800
- Sponsor's protocol ID
- 18-0008
- Status last verified
- Oct 2018
- First submitted
- 28 Feb 2018
- Last updated
- 19 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Mechanisms of Exercise Behavior Change
- ClinicalTrials.gov ID
- NCT03465800
- Acronym / sponsor ID
- 18-0008
- Conditions
- Overweight and Obesity, Physical Activity, Incentives
- Keywords
- overweight, obesity, physical activity, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 11 Jul 2018 (actual)
- First posted
- 14 Mar 2018 (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.
This research seeks to examine psychological factors that may impact relationship between incentives and health behavior engagement, specifically physical activity. Additionally, it will compare the impact of two different incentive schedules on behavior engagement, one providing immediate rewards (i.e. rewards received on a daily basis) and another providing delayed rewards (i.e. rewards received at the end of the study period), with an active self-monitoring intervention condition in which no rewards are offered. Study participants will provide reports of their physical activity each day for three weeks, and in the two incentive conditions, they will receive small monetary rewards for their physical activity. Following the three week reporting and reward period, participants will complete two additional assessments, measuring psychological constructs and behavior engagement following the cessation of rewards. The study will also examine how cognitive and anthropomorphic factors may contribute to intervention response and the effects on psychological constructs.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Self-Monitoring | Active comparator | Behavioral: self-monitoringParticipants self-monitor their physical activity |
| Daily Incentives | Experimental | Behavioral: self-monitoring, Behavioral: daily incentivesdaily payments for physical activity |
| Delayed Lump Sum Incentives | Experimental | Behavioral: self-monitoring, Behavioral: delayed lump sum incentiveslump sum payments for physical activity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Complete less than 150 minutes of moderate-vigorous physical activity weekly
- Daily access to the internet for 3 weeks following baseline research visit
- Have or are willing to create an account on PayPal
- Willing to wear a heart rate monitor watch during physical activity for 3 weeks
- BMI greater than or equal to 25, from self-reported height and weight
Key exclusion criteria (1 listed)
- Diagnosis of cardiovascular, metabolic, or renal disease
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 |
|---|---|---|
| self-monitoringself-monitoring of physical activity | Behavioural | Daily Incentives, Delayed Lump Sum Incentives, Self-Monitoring |
| daily incentivesdaily incentive payments for physical activity | Behavioural | Daily Incentives |
| delayed lump sum incentivesdelayed lump sum payments for physical activity | Behavioural | Delayed Lump Sum Incentives |
Primary outcome
Moderate-vigorous physical activity minutes
Time frame: Week 3
summed minutes of weekly moderate intensity physical activity \& vigorous intensity physical activity
Self-Efficacy for physical activity
Time frame: Week 3
8-item self-report scale measuring self-efficacy (Social Cognitive Theory, Bandura, 1977; also called "perceived behavioral control", Theory of Planned Behavior, Ajzen, 1985); scores are a mean of 8 items, scored 1-7 with higher scores indicative of greater self-efficacy
Moderate-vigorous physical activity minutes
Time frame: Week 5
summed minutes of weekly moderate intensity physical activity \& vigorous intensity physical activity
Self-Efficacy for physical activity
Time frame: Week 5
8-item self-report scale measuring self-efficacy (Social Cognitive Theory, Bandura, 1977; also called "perceived behavioral control", Theory of Planned Behavior, Ajzen, 1985); scores are a mean of 8 items, scored 1-7 with higher scores indicative of greater self-efficacy
Attitudes toward physical activity
Time frame: Week 3
12-item self-report scale (Theory of Planned Behavior, Ajzen, 1985); scores are a mean of 12 items scored from -5 to +5, with higher scores indicative of more positive attitudes
Attitudes toward physical activity
Time frame: Week 5
12-item self-report scale (Theory of Planned Behavior, Ajzen, 1985); scores are a mean of 12 items scored from -5 to +5, with higher scores indicative of more positive attitudes
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 19 Oct 2018.
- Individual participant dataSharing planned: No
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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 self-monitoring, daily incentives and delayed lump sum incentives in people with Overweight and Obesity and Physical Activity, run by University of Colorado, Boulder 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 5 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 19 Oct 2018. 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?
Moderate-vigorous physical activity minutes (time frame: Week 3). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2018.