Diet, HealthyNCT04242693
Mobile Goal-setting Intervention to Improve Vegetable Intake Among Young College Students
A study testing Mobile goal-setting intervention in people with Diet, Healthy, run by Indiana University at 1 site in United States.
Trial summary
This study used a two-group pre-posttest experimental design. After completing a background survey, participants used their smartphones to uploaded photos and/or descriptions of their meals to an online platform for three days. Read more about this study
- Who is it for?
- Ages 18 to 23 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy
- What is being tested?
- Mobile goal-setting intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 281 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2018to 25 Apr 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 to 23 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18 and above
- Undergraduate at the university
- Currently lived in a dorm
- Owned a smartphone
- Had internet access on their smartphone
Who cannot join
- Already part of a study to change their eating behaviors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Self-Monitoring and Goal Setting on Improving Consumption of Red/Orange Vegetables Among Undergraduate Students: A Pre-Posttest Experiment
This study used a two-group pre-posttest experimental design. After completing a background survey, participants used their smartphones to uploaded photos and/or descriptions of their meals to an online platform for three days. In addition, those in the intervention group were asked to use a checklist to count the number of times they ate red/orange vegetables and to set a goal to eat one more time the next day. The dependent variable was a measure of eating behavior-an estimate (number of times/day) of red/orange vegetable intake on that day based on review of uploaded photos and descriptions. Those in the intervention group, who were asked to use a checklist to count their red/orange vegetable intake and set a goal to eat one more the next day, improved their vegetable intake.
- Conditions
- Diet, Healthy
- Being tested
- Mobile goal-setting intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile goal-setting interventionBehavioural
This intervention applied two constructs from the goal setting theory-self-monitoring and goal setting. Briefly, all participants were asked to take photos of all their meals and upload them with descriptions to an online platform. The participants in the experimental group were taken through two additional processes that represented these two constructs. Self-monitoring was operationalized by asking those in the experimental group to count the number of times they ate red/orange vegetables using a counting checklist. Goal setting was operationalized as asking them to set a goal to eat red/orange vegetables one more time tomorrow.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The experimental group were asked to count the number of times they ate any red/orange vegetables and set a goal to eat one more time the next day over three days. Receives: Behavioral: Mobile goal-setting intervention |
| Control Group | No intervention | The control group uploaded photos and/or descriptions of their meals only. They did not self-monitor their vegetable intake nor set a goal to eat more. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Red/orange vegetable intake
Number of times participants consumed red/orange vegetables
Measured: Three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start18 Feb 2018
- Primary completion25 Apr 2018
- Study completion25 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, HealthyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized to either an experimental or a control group after they completed a preliminary questionnaire.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Trishnee Bhurosy, PhD, Indiana University
- Investigators
- Susan E Middlestadt, PhD, Study chair, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242693
- Sponsor's protocol ID
- 1711199200
- Status last verified
- Jan 2020
- First submitted
- 23 Jan 2020
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant data can be shared upon reasonable request. There are identifiers with respect to photos and descriptions provided by participants in the study and these are confidential.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Self-Monitoring and Goal Setting on Improving Consumption of Red/Orange Vegetables Among Undergraduate Students: A Pre-Posttest Experiment
- ClinicalTrials.gov ID
- NCT04242693
- Acronym / sponsor ID
- 1711199200
- Conditions
- Diet, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 18 Feb 2018 (actual)
- Primary completion
- 25 Apr 2018 (actual)
- Study completion
- 25 Apr 2018 (actual)
- First posted
- 27 Jan 2020 (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 study used a two-group pre-posttest experimental design. After completing a background survey, participants used their smartphones to uploaded photos and/or descriptions of their meals to an online platform for three days. In addition, those in the intervention group were asked to use a checklist to count the number of times they ate red/orange vegetables and to set a goal to eat one more time the next day. The dependent variable was a measure of eating behavior-an estimate (number of times/day) of red/orange vegetable intake on that day based on review of uploaded photos and descriptions. Those in the intervention group, who were asked to use a checklist to count their red/orange vegetable intake and set a goal to eat one more the next day, improved their vegetable intake.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants were randomized to either an experimental or a control group after they completed a preliminary questionnaire.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Mobile goal-setting interventionThe experimental group were asked to count the number of times they ate any red/orange vegetables and set a goal to eat one more time the next day over three days. |
| Control Group | No intervention | –The control group uploaded photos and/or descriptions of their meals only. They did not self-monitor their vegetable intake nor set a goal to eat more. |
Who may qualify
- Ages
- 18 to 23 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 18 and above
- Undergraduate at the university
- Currently lived in a dorm
- Owned a smartphone
- Had internet access on their smartphone
Key exclusion criteria (1 listed)
- Already part of a study to change their eating behaviors
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 |
|---|---|---|
| Mobile goal-setting interventionThis intervention applied two constructs from the goal setting theory-self-monitoring and goal setting. Briefly, all participants were asked to take photos of all their meals and upload them with descriptions to an online platform. The participants in the experimental group were taken through two additional processes that represented these two constructs. Self-monitoring was operationalized by asking those in the experimental group to count the number of times they ate red/orange vegetables using a counting checklist. Goal setting was operationalized as asking them to set a goal to eat red/orange vegetables one more time tomorrow. | Behavioural | Experimental Group |
Primary outcome
Red/orange vegetable intake
Time frame: Three days
Number of times participants consumed red/orange vegetables
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 27 Jan 2020.
- Individual participant dataSharing planned: Yes. Participant data can be shared upon reasonable request. There are identifiers with respect to photos and descriptions provided by participants in the study and these are confidential.
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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.
Susan E Middlestadt, PhD study chair
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile goal-setting intervention in people with Diet, Healthy, run by Indiana University 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 27 Jan 2020. 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?
Red/orange vegetable intake (time frame: Three days). 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 27 Jan 2020.