- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02585102
Motivating Value of Vegetables Study (VegUp)
August 5, 2020 updated by: USDA Grand Forks Human Nutrition Research Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
102
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Dakota
-
Grand Forks, North Dakota, United States, 58203
- USDA Grand Forks Human Nutrition Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- BMI ≥ 25 kg/m2
- Currently eating ≤ 1 cup of vegetables (apart from fried potatoes) per day
- Willing to consent to study conditions
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Recommended Vegetables
Diet provided consisting of recommended vegetable intake per Dietary Guidelines for Americans amounts for 8 weeks.
|
Subjects will consume vegetables in amounts recommended by the Dietary Guidelines for Americans
|
|
Other: Usual Vegetables
Diet consisting of usual vegetable intake amounts for 8 weeks.
|
Subjects will consume vegetables in their usual amount
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
0, 4, 8, 12, 16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in happiness in response to eating vegetables
Time Frame: 0, 8 weeks
|
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.
|
0, 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: James N Roemmich, PhD, USDA Grand Forks Human Nutrition Research Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Cao 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.
- Casperson 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2015
Primary Completion (Actual)
January 12, 2018
Study Completion (Actual)
January 12, 2018
Study Registration Dates
First Submitted
October 21, 2015
First Submitted That Met QC Criteria
October 21, 2015
First Posted (Estimate)
October 23, 2015
Study Record Updates
Last Update Posted (Actual)
August 7, 2020
Last Update Submitted That Met QC Criteria
August 5, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GFHNRC099
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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