OverweightVegUpNCT02585102
Motivating Value of Vegetables Study
A study testing Recommended Vegetable Intake and Usual Vegetable Intake in people with Overweight and Obesity, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
Trial summary
The purpose of this study is to see if perceived barriers to vegetable consumption can be overcome by making it easier for people eat more vegetables and to see if the effects last over time. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Recommended Vegetable Intake and Usual Vegetable Intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 12 Jan 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI ≥ 25 kg/m2
- Currently eating ≤ 1 cup of vegetables (apart from fried potatoes) per day
- Willing to consent to study conditions
Who cannot join
- BMI < 25 kg/m2
- Age < 18 years or > 65 years
- Currently dieting or following specific diet
- Allergies or unwillingness to consume study foods
- Gastrointestinal disorder or disease
- Pregnant, lactating, or planning pregnancy
Show all 11Show fewer
- Current smoker or tobacco user
- High dietary restraint or certain eating patterns
- Inability to give consent
- Medications that would influence appetite, weight gain, or weight loss
- Exclusionary medications: Didrex, Tenuate, Belviq, Contrave, Phendimetrazine, Adipex-P, Suprenza, Xenical, Qsymia, Saxenda
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: Increasing the Relative Reinforcing Values of Vegetables by Incentive Sensitization
The purpose of this study is to see if perceived barriers to vegetable consumption can be overcome by making it easier for people eat more vegetables and to see if the effects last over time.
Read the detailed description
High vegetable consumption is associated with maintenance of a healthy body weight. Americans do not eat vegetables in the amounts recommended by the dietary guidelines and interventions to increase intake have had limited results. Reported barriers to consumption include not knowing how to prepare them and being unused to eating them.To get people to eat vegetables, they have to be motivated to do so. Repeated consumption of snack foods increases overweight and obese individuals' motivation to eat snack foods. The investigators hypothesize that by increasing people's consumption of vegetables by making them easy to eat will increase the motivation value of vegetables. For this study the investigators propose to provide minimally-processed (cleaned, packaged) vegetables to overweight and obese individuals. The motivating value of vegetables will be measured using a computer task where people play a game to earn points towards portions of a vegetable or a neutral food (crackers). The investigators will determine potential moderators of the increase in the motivating value of vegetables such as genetics (single nucleotide polymorphisms) that are associated with the motivating value of food and whether people substitute eating vegetables for other foods. The investigators will also determine changes in adiposity as a result of vegetable consumption. Lastly, the investigators will determine if repeated consumption increases psychosocial predictors of vegetable intake, such as self-efficacy of eating vegetables.
- Conditions
- Overweight, Obesity
- Being tested
- Recommended Vegetable Intake, Usual Vegetable Intake
- Keywords
- Vegetables
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recommended Vegetable IntakeOther
Subjects will consume vegetables in amounts recommended by the Dietary Guidelines for Americans
Usual Vegetable IntakeOther
Subjects will consume vegetables in their usual amount
| Study group | Role | What they receive |
|---|---|---|
| Recommended Vegetables | Other | Diet provided consisting of recommended vegetable intake per Dietary Guidelines for Americans amounts for 8 weeks. Receives: Other: Recommended Vegetable Intake |
| Usual Vegetables | Other | Diet consisting of usual vegetable intake amounts for 8 weeks. Receives: Other: Usual Vegetable Intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in relative reinforcing value (RRV) of vegetables as assessed by indicator
RRV of vegetables will be assessed by evaluating the number of responses (mouse button presses) a participant is willing to complete to gain access to a vegetable or an alternative snack food.
Measured: 0, 4, 8, 12, 16 weeks
Secondary outcomes (1)
Change in happiness in response to eating vegetables
Happiness will be assessed using a validated questionnaire, the "4-item Subjective Happiness Scale," a 7 point Likert scale with 1=not a very happy person to 7=a very happy person, before and after consuming Dietary Guidelines for Americans (DGA) recommended amounts of vegetables.
Measured: 0, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study startOct 2015
- Primary completion12 Jan 2018
- Study completion12 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Grand Forks Human Nutrition Research Center
- Sponsor type
- US federal agency
- Collaborators
- USDA, Western Human Nutrition Research Center, University at Buffalo
- Responsible party
- Sponsor
- Investigators
- James N Roemmich, PhD, Principal investigator, USDA Grand Forks Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02585102
- Sponsor's protocol ID
- GFHNRC099
- Acronym
- VegUp
- Status last verified
- Aug 2020
- First submitted
- 21 Oct 2015
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Casperson SL, Jahns L, Duke SE, Nelson AM, Appleton KM, Larson KJ, Roemmich JN. Incorporating the Dietary Guidelines for Americans Vegetable Recommendations into the Diet Alters Dietary Intake Patterns of Other Foods and Improves Diet Quality in Adults with Overweight and Obesity. J Acad Nutr Diet. 2022 Jul;122(7):1345-1354.e1. doi: 10.1016/j.jand.2022.03.008. Epub 2022 Mar 9.
PubMed 35278698Cao JJ, Roemmich JN, Sheng X, Jahns L. Increasing Vegetable Intake Decreases Urinary Acidity and Bone Resorption Marker in Overweight and Obese Adults: An 8-Week Randomized Controlled Trial. J Nutr. 2021 Nov 2;151(11):3413-3420. doi: 10.1093/jn/nxab255.
PubMed 34386816Casperson SL, Jahns L, Temple JL, Appleton KM, Duke SE, Roemmich JN. Consumption of a Variety of Vegetables to Meet Dietary Guidelines for Americans' Recommendations Does Not Induce Sensitization of Vegetable Reinforcement Among Adults with Overweight and Obesity: A Randomized Controlled Trial. J Nutr. 2021 Jun 1;151(6):1665-1672. doi: 10.1093/jn/nxab049.
PubMed 33758940
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing the Relative Reinforcing Values of Vegetables by Incentive Sensitization
- ClinicalTrials.gov ID
- NCT02585102
- Acronym / sponsor ID
- VegUp / GFHNRC099
- Conditions
- Overweight, Obesity
- Keywords
- Vegetables
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- USDA Grand Forks Human Nutrition Research CenterUS federal agency
- Collaborators
- USDA, Western Human Nutrition Research Center, University at Buffalo
- Study start
- Oct 2015 (actual)
- Primary completion
- 12 Jan 2018 (actual)
- Study completion
- 12 Jan 2018 (actual)
- First posted
- 23 Oct 2015 (estimated)
- 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 see if perceived barriers to vegetable consumption can be overcome by making it easier for people eat more vegetables and to see if the effects last over time.
Detailed description
High vegetable consumption is associated with maintenance of a healthy body weight. Americans do not eat vegetables in the amounts recommended by the dietary guidelines and interventions to increase intake have had limited results. Reported barriers to consumption include not knowing how to prepare them and being unused to eating them.To get people to eat vegetables, they have to be motivated to do so. Repeated consumption of snack foods increases overweight and obese individuals' motivation to eat snack foods. The investigators hypothesize that by increasing people's consumption of vegetables by making them easy to eat will increase the motivation value of vegetables. For this study the investigators propose to provide minimally-processed (cleaned, packaged) vegetables to overweight and obese individuals. The motivating value of vegetables will be measured using a computer task where people play a game to earn points towards portions of a vegetable or a neutral food (crackers). The investigators will determine potential moderators of the increase in the motivating value of vegetables such as genetics (single nucleotide polymorphisms) that are associated with the motivating value of food and whether people substitute eating vegetables for other foods. The investigators will also determine changes in adiposity as a result of vegetable consumption. Lastly, the investigators will determine if repeated consumption increases psychosocial predictors of vegetable intake, such as self-efficacy of eating vegetables.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recommended Vegetables | Other | Other: Recommended Vegetable IntakeDiet provided consisting of recommended vegetable intake per Dietary Guidelines for Americans amounts for 8 weeks. |
| Usual Vegetables | Other | Other: Usual Vegetable IntakeDiet consisting of usual vegetable intake amounts for 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI ≥ 25 kg/m2
- Currently eating ≤ 1 cup of vegetables (apart from fried potatoes) per day
- Willing to consent to study conditions
Key exclusion criteria (11 listed)
- BMI < 25 kg/m2
- Age < 18 years or > 65 years
- Currently dieting or following specific diet
- Allergies or unwillingness to consume study foods
- Gastrointestinal disorder or 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 |
|---|---|---|
| Recommended Vegetable IntakeSubjects will consume vegetables in amounts recommended by the Dietary Guidelines for Americans | Other | Recommended Vegetables |
| Usual Vegetable IntakeSubjects will consume vegetables in their usual amount | Other | Usual Vegetables |
Primary outcome
Change in relative reinforcing value (RRV) of vegetables as assessed by indicator
Time frame: 0, 4, 8, 12, 16 weeks
RRV of vegetables will be assessed by evaluating the number of responses (mouse button presses) a participant is willing to complete to gain access to a vegetable or an alternative snack food.
1 secondary outcome
Change in happiness in response to eating vegetables
Time frame: 0, 8 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 7 Aug 2020.
- Derived from this study: PubMed 35278698Casperson SL, Jahns L, Duke SE, Nelson AM, Appleton KM, Larson KJ, Roemmich JN. Incorporating the Dietary Guidelines for Americans Vegetable Recommendations into the Diet Alters Dietary Intake Patterns of Other Foods and Improves Diet Quality in Adults with Overweight and Obesity. J Acad Nutr Diet. 2022 Jul;122(7):1345-1354.e1. doi: 10.1016/j.jand.2022.03.008. Epub 2022 Mar 9.
- Derived from this study: PubMed 34386816Cao JJ, Roemmich JN, Sheng X, Jahns L. Increasing Vegetable Intake Decreases Urinary Acidity and Bone Resorption Marker in Overweight and Obese Adults: An 8-Week Randomized Controlled Trial. J Nutr. 2021 Nov 2;151(11):3413-3420. doi: 10.1093/jn/nxab255.
- Derived from this study: PubMed 33758940Casperson SL, Jahns L, Temple JL, Appleton KM, Duke SE, Roemmich JN. Consumption of a Variety of Vegetables to Meet Dietary Guidelines for Americans' Recommendations Does Not Induce Sensitization of Vegetable Reinforcement Among Adults with Overweight and Obesity: A Randomized Controlled Trial. J Nutr. 2021 Jun 1;151(6):1665-1672. doi: 10.1093/jn/nxab049.
- 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.
James N Roemmich, 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?
A study testing Recommended Vegetable Intake and Usual Vegetable Intake in people with Overweight and Obesity, 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 3 inclusion and 11 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 7 Aug 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?
Change in relative reinforcing value (RRV) of vegetables as assessed by indicator (time frame: 0, 4, 8, 12, 16 weeks). 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 NCT02585102, which also lists 3 linked publications.
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 7 Aug 2020; AzTrials last refreshed its copy on 4 Nov 2026.