NCT02585102

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2018

Completed
Last Updated

August 7, 2020

Status Verified

August 1, 2020

Enrollment Period

2.3 years

First QC Date

October 21, 2015

Last Update Submit

August 5, 2020

Conditions

OverweightObesity

Keywords

Vegetables

Outcome Measures

Primary Outcomes (1)

  • 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.

    0, 4, 8, 12, 16 weeks

Secondary Outcomes (1)

  • Change in happiness in response to eating vegetables

    0, 8 weeks

Study Arms (2)

Recommended Vegetables

OTHER

Diet provided consisting of recommended vegetable intake per Dietary Guidelines for Americans amounts for 8 weeks.

Other: Recommended Vegetable Intake

Usual Vegetables

OTHER

Diet consisting of usual vegetable intake amounts for 8 weeks.

Other: Usual Vegetable Intake

Interventions

Recommended Vegetable IntakeOTHER

Subjects will consume vegetables in amounts recommended by the Dietary Guidelines for Americans

Recommended Vegetables
Usual Vegetable IntakeOTHER

Subjects will consume vegetables in their usual amount

Usual Vegetables

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI ≥ 25 kg/m2
  • Currently eating ≤ 1 cup of vegetables (apart from fried potatoes) per day
  • Willing to consent to study conditions

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USDA Grand Forks Human Nutrition Research Center

Grand Forks, North Dakota, 58203, United States

Location

Related Publications (3)

  • 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.

    PMID: 35278698DERIVED

  • 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.

    PMID: 34386816DERIVED

  • 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.

    PMID: 33758940DERIVED

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • James N Roemmich, PhD

    USDA Grand Forks Human Nutrition Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2015

First Posted

October 23, 2015

Study Start

October 1, 2015

Primary Completion

January 12, 2018

Study Completion

January 12, 2018

Last Updated

August 7, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)