Overweight and ObesityNCT03192254
Understanding Mechanisms of Health Behavior Change
A study testing self-monitoring, daily monetary incentives and delayed lump sum monetary incentives in people with Overweight and Obesity and Diet Modification, 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 fruit and vegetable consumption. 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, Diet Modification, Incentives
- What is being tested?
- self-monitoring, daily monetary incentives and delayed lump sum monetary 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
- 13 Jul 2017to 30 Mar 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
- Consume fewer than 3 servings/day of fruits and vegetables
- Daily access to internet for 3 weeks following baseline session
- Have or are willing to create an account on PayPal
- BMI greater than or equal to 25, from self-reported height and weight
Who cannot join
- -
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 fruit and vegetable consumption. 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 a control condition in which no rewards are offered. Study participants will provide reports of their fruit and vegetable consumption each day for three weeks, and in the two incentive conditions, they will receive small monetary rewards for their fruit and vegetable consumption. 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, Diet Modification, Incentives
- Being tested
- self-monitoring, daily monetary incentives, delayed lump sum monetary incentives
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-monitoringBehavioural
recording fruit and vegetable consumption
daily monetary incentivesBehavioural
daily payments for consuming fruits and vegetables
delayed lump sum monetary incentivesBehavioural
lump sum payments for consuming fruits and vegetables
| Study group | Role | What they receive |
|---|---|---|
| Self-Monitoring Control | Active comparator | Daily tracking of fruit and vegetable consumption Receives: Behavioral: self-monitoring |
| Daily Incentives | Experimental | Incentives for fruit and vegetable consumption delivered daily Receives: Behavioral: self-monitoring; Behavioral: daily monetary incentives |
| Delayed Lump Sum Incentives | Experimental | Incentives for fruit and vegetable consumption delivered in a lump sum at the end of the intervention Receives: Behavioral: self-monitoring; Behavioral: delayed lump sum monetary incentives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fruit and vegetable consumption, servings per week
Measured: 3 Weeks
Fruit and vegetable consumption, servings per week
Measured: 5 Weeks
Perceived behavioral control scale score
Measured: 3 Weeks
Perceived behavioral control scale score
Measured: 5 Weeks
Attitude scale score
Measured: 3 Weeks
Attitude scale score
Measured: 5 Weeks
Secondary outcomes (2)
Intrinsic motivation scale score
Measured: 3 Weeks
Intrinsic motivation scale score
Measured: 5 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start13 Jul 2017
- Primary completion21 Feb 2018
- Study completion30 Mar 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
- NCT03192254
- Sponsor's protocol ID
- 16-0700
- Status last verified
- Jul 2023
- First submitted
- 16 Jun 2017
- Last updated
- 1 Aug 2023
- 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 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Mechanisms of Health Behavior Change
- ClinicalTrials.gov ID
- NCT03192254
- Acronym / sponsor ID
- 16-0700
- Conditions
- Overweight and Obesity, Diet Modification, Incentives
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Study start
- 13 Jul 2017 (actual)
- Primary completion
- 21 Feb 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 20 Jun 2017 (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 fruit and vegetable consumption. 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 a control condition in which no rewards are offered. Study participants will provide reports of their fruit and vegetable consumption each day for three weeks, and in the two incentive conditions, they will receive small monetary rewards for their fruit and vegetable consumption. 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 Control | Active comparator | Behavioral: self-monitoringDaily tracking of fruit and vegetable consumption |
| Daily Incentives | Experimental | Behavioral: self-monitoring, Behavioral: daily monetary incentivesIncentives for fruit and vegetable consumption delivered daily |
| Delayed Lump Sum Incentives | Experimental | Behavioral: self-monitoring, Behavioral: delayed lump sum monetary incentivesIncentives for fruit and vegetable consumption delivered in a lump sum at the end of the intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Consume fewer than 3 servings/day of fruits and vegetables
- Daily access to internet for 3 weeks following baseline session
- Have or are willing to create an account on PayPal
- BMI greater than or equal to 25, from self-reported height and weight
Key exclusion criteria (1 listed)
- -
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-monitoringrecording fruit and vegetable consumption | Behavioural | Daily Incentives, Delayed Lump Sum Incentives, Self-Monitoring Control |
| daily monetary incentivesdaily payments for consuming fruits and vegetables | Behavioural | Daily Incentives |
| delayed lump sum monetary incentiveslump sum payments for consuming fruits and vegetables | Behavioural | Delayed Lump Sum Incentives |
Primary outcome
Fruit and vegetable consumption, servings per week
Time frame: 3 Weeks
Fruit and vegetable consumption, servings per week
Time frame: 5 Weeks
Perceived behavioral control scale score
Time frame: 3 Weeks
Perceived behavioral control scale score
Time frame: 5 Weeks
Attitude scale score
Time frame: 3 Weeks
Attitude scale score
Time frame: 5 Weeks
2 secondary outcomes
Intrinsic motivation scale score
Time frame: 3 Weeks
Intrinsic motivation scale score
Time frame: 5 Weeks
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 1 Aug 2023.
- 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 monetary incentives and delayed lump sum monetary incentives in people with Overweight and Obesity and Diet Modification, 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 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 1 Aug 2023. 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?
Fruit and vegetable consumption, servings per week (time frame: 3 Weeks). 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 1 Aug 2023.