OverweightNCT03607526
Barriers and Facilitators to Vegetable Intake
An observational study of Overweight and Obese, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
Trial summary
The purpose of this study is to find out why people do or do not eat vegetables. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obese
- What is being tested?
- Barriers and Facilitators
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2018to 6 May 2019
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Recruitment will be limited to contacting participants who previously took part in a study (NCT02585102) and upon completion of that study indicated willingness to be contacted for a follow-up study. The original study recruited overweight or obese adults who reported consuming not more than 1 serving of vegetables per day. In that study, participants were provided vegetables or were in a control group. Research staff will send invitations to participate in one of the NGT sessions.
Who may be able to join
- Participant in NCT02585102 who gave permission to be contacted for a follow-up study.
Who cannot join
- Did not participate in NCT02585102.
- Participant in NCT02585102 who did not give permission to be contacted for a follow-up study.
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, 58203
About this study
Official title: Barriers and Facilitators to Following the Dietary Guidelines for Vegetable Intake: Follow-up of an Intervention to Increase Vegetable Consumption
The purpose of this study is to find out why people do or do not eat vegetables.
Read the detailed description
The Dietary Guidelines for Americans (DGA) stress the importance of a diet high in fruits and vegetables (FV) to achieve health benefits. Despite the recommendations, adherence is low; only 12% of the population meets the recommendation for fruits and even less of the population (9%) meets the recommendation for vegetables. Recently, it was found that vegetable consumption increased when individuals were provided the recommended daily amounts while participating in a clinical study, but returned to pre-study low levels when vegetables were no longer supplied. This result suggests that habitual consumption of FV is strongly regulated by behaviors influenced by social, environmental, and/or individual factors. Therefore, identifying regulatory factors of vegetable consumption will greatly assist in developing successful strategies to increase vegetable intake to achieve health benefits. The overall objective of this study is to examine both barriers and facilitators to adherence to consuming DGA-recommended amounts of vegetables in participants who completed a randomized controlled trial with provided vegetables or who were in a control group, using the Nominal Group Technique (NGT).
- Conditions
- Overweight, Obese
- Being tested
- Barriers, Facilitators
- Keywords
- Vegetable Intake
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BarriersOther
NGT sessions identifying barriers to vegetable intake.
FacilitatorsOther
NGT sessions identifying facilitators to vegetable intake.
| Study group | Role | What they receive |
|---|---|---|
| Barriers to Vegetable Consumption | Four groups of participants will meet for NGT sessions, identifying barriers to meeting the DGA recommendation for vegetable consumption. Receives: Other: Barriers | |
| Facilitators to Vegetable Consumption | Four groups of participants will meet for NGT sessions, identifying facilitators to meeting the DGA recommendation for vegetable consumption. Receives: Other: Facilitators |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barriers and facilitators to vegetable consumption
NGT results providing an exhaustive list of barriers and facilitators to meeting the DGA for vegetable consumption.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start26 Jun 2018
- Primary completion6 May 2019
- Study completion6 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Grand Forks Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Shanon Casperson, PhD, Principal investigator, USDA Grand Forks Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607526
- Sponsor's protocol ID
- GFHNRC152
- Status last verified
- Jan 2022
- First submitted
- 23 Jul 2018
- Last updated
- 2 Feb 2022
- 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 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barriers and Facilitators to Following the Dietary Guidelines for Vegetable Intake: Follow-up of an Intervention to Increase Vegetable Consumption
- ClinicalTrials.gov ID
- NCT03607526
- Acronym / sponsor ID
- GFHNRC152
- Conditions
- Overweight, Obese
- Keywords
- Vegetable Intake
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- USDA Grand Forks Human Nutrition Research CenterUS federal agency
- Study start
- 26 Jun 2018 (actual)
- Primary completion
- 6 May 2019 (actual)
- Study completion
- 6 May 2019 (actual)
- First posted
- 31 Jul 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.
The purpose of this study is to find out why people do or do not eat vegetables.
Detailed description
The Dietary Guidelines for Americans (DGA) stress the importance of a diet high in fruits and vegetables (FV) to achieve health benefits. Despite the recommendations, adherence is low; only 12% of the population meets the recommendation for fruits and even less of the population (9%) meets the recommendation for vegetables. Recently, it was found that vegetable consumption increased when individuals were provided the recommended daily amounts while participating in a clinical study, but returned to pre-study low levels when vegetables were no longer supplied. This result suggests that habitual consumption of FV is strongly regulated by behaviors influenced by social, environmental, and/or individual factors. Therefore, identifying regulatory factors of vegetable consumption will greatly assist in developing successful strategies to increase vegetable intake to achieve health benefits. The overall objective of this study is to examine both barriers and facilitators to adherence to consuming DGA-recommended amounts of vegetables in participants who completed a randomized controlled trial with provided vegetables or who were in a control group, using the Nominal Group Technique (NGT).
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Barriers to Vegetable Consumption | – | Other: BarriersFour groups of participants will meet for NGT sessions, identifying barriers to meeting the DGA recommendation for vegetable consumption. |
| Facilitators to Vegetable Consumption | – | Other: FacilitatorsFour groups of participants will meet for NGT sessions, identifying facilitators to meeting the DGA recommendation for vegetable consumption. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Recruitment will be limited to contacting participants who previously took part in a study (NCT02585102) and upon completion of that study indicated willingness to be contacted for a follow-up study. The original study recruited overweight or obese adults who reported consuming not more than 1 serving of vegetables per day. In that study, participants were provided vegetables or were in a control group. Research staff will send invitations to participate in one of the NGT sessions.
Key inclusion criteria (1 listed)
- Participant in NCT02585102 who gave permission to be contacted for a follow-up study.
Key exclusion criteria (2 listed)
- Did not participate in NCT02585102.
- Participant in NCT02585102 who did not give permission to be contacted for a follow-up study.
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 |
|---|---|---|
| BarriersNGT sessions identifying barriers to vegetable intake. | Other | Barriers to Vegetable Consumption |
| FacilitatorsNGT sessions identifying facilitators to vegetable intake. | Other | Facilitators to Vegetable Consumption |
Primary outcome
Barriers and facilitators to vegetable consumption
Time frame: 2 hours
NGT results providing an exhaustive list of barriers and facilitators to meeting the DGA for vegetable consumption.
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 2 Feb 2022.
- Grand Forks Human Nutrition Research Center Current Nutrition StudiesLink provided by the sponsor.
- 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.
Shanon Casperson, PhD principal investigator
USDA Grand Forks Human Nutrition Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight and Obese, run by USDA Grand Forks Human Nutrition Research Center 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 1 inclusion and 2 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 2 Feb 2022. 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?
Barriers and facilitators to vegetable consumption (time frame: 2 hours). 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 2 Feb 2022.