Motivating Value of Vegetables Study (VegUp)
Primary Purpose
Overweight, Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Recommended Vegetable Intake
Usual Vegetable Intake
Sponsored by
About this trial
This is an interventional other trial for Overweight focused on measuring Vegetables
Eligibility Criteria
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
Sites / Locations
- USDA Grand Forks Human Nutrition Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Recommended Vegetables
Usual Vegetables
Arm Description
Diet provided consisting of recommended vegetable intake per Dietary Guidelines for Americans amounts for 8 weeks.
Diet consisting of usual vegetable intake amounts for 8 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02585102
First Posted
October 21, 2015
Last Updated
August 5, 2020
Sponsor
USDA Grand Forks Human Nutrition Research Center
Collaborators
USDA, Western Human Nutrition Research Center, University at Buffalo
1. Study Identification
Unique Protocol Identification Number
NCT02585102
Brief Title
Motivating Value of Vegetables Study
Acronym
VegUp
Official Title
Increasing the Relative Reinforcing Values of Vegetables by Incentive Sensitization
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
January 12, 2018 (Actual)
Study Completion Date
January 12, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
USDA Grand Forks Human Nutrition Research Center
Collaborators
USDA, Western Human Nutrition Research Center, University at Buffalo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Vegetables
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Recommended Vegetables
Arm Type
Other
Arm Description
Diet provided consisting of recommended vegetable intake per Dietary Guidelines for Americans amounts for 8 weeks.
Arm Title
Usual Vegetables
Arm Type
Other
Arm Description
Diet consisting of usual vegetable intake amounts for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Recommended Vegetable Intake
Intervention Description
Subjects will consume vegetables in amounts recommended by the Dietary Guidelines for Americans
Intervention Type
Other
Intervention Name(s)
Usual Vegetable Intake
Intervention Description
Subjects will consume vegetables in their usual amount
Primary Outcome Measure Information:
Title
Change in relative reinforcing value (RRV) of vegetables as assessed by indicator
Description
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.
Time Frame
0, 4, 8, 12, 16 weeks
Secondary Outcome Measure Information:
Title
Change in happiness in response to eating vegetables
Description
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.
Time Frame
0, 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James N Roemmich, PhD
Organizational Affiliation
USDA Grand Forks Human Nutrition Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
USDA Grand Forks Human Nutrition Research Center
City
Grand Forks
State/Province
North Dakota
ZIP/Postal Code
58203
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35278698
Citation
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.
Results Reference
derived
PubMed Identifier
34386816
Citation
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.
Results Reference
derived
PubMed Identifier
33758940
Citation
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.
Results Reference
derived
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Motivating Value of Vegetables Study
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