- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03078660
Pilot Trial to Test a Nutrition Application for Making Smart and Healthy Choices
March 7, 2017 updated by: University of Puerto Rico
Pilot Trial to Test a Nutrition Application for Making Smart and Healthy Choices When Purchasing Food in Grocery Stores
An innovative nutritional application (App) entitled "MyNutriCart" was developed to create a list of foods and beverages to help individuals make smart and healthy choices when purchasing foods at grocery stores based on the Dietary Guidelines for Americans.
This App was tested in a pilot trial to evaluate its feasibility, usability, and acceptability for making smart and healthy choices when purchasing food in grocery stores and test its effectiveness in improving food selection, dietary patterns, and weight status compared with the traditional nutritional counseling.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
An innovative nutritional application (App) entitled "MyNutriCart" was developed to create a list of foods and beverages to help individuals make smart and healthy choices when purchasing foods at grocery stores based on the Dietary Guidelines for Americans.
A pilot randomized clinical trial was done to test the effectiveness of this App on food selection and purchase, dietary patterns, and weight loss during two months of intervention.
We also assessed feasibility, usability, satisfaction and acceptability of the App.
A total of 138 overweight and obese adults aged 21-45 years old who own a Smartphone were invited to participate in this study.
Participants were randomized into two groups; (1) the intervention group used the App, which generated a healthy grocery list to use when purchasing foods in in the supermarket; (2) the control group had a traditional intervention with a nutritionist.
To assess the impact of the intervention on dietary patterns, participants completed three 24-hour dietary recalls, a short food frequency questionnaire (FFQ) and provided grocery receipts at baseline and at the end of the study (8 weeks later).
Weight and height were also performed before and after the intervention.
Feasibility, usability, satisfaction, and acceptability of the nutrition App were assessed at the end of the study using a questionnaire.
Study Type
Interventional
Enrollment (Actual)
38
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
-
-
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San Juan, Puerto Rico, 00936-5067
- University of Puerto Rico, Medical Sciences Campus (UPR-MSC)
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-
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
21 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- overweight/obese adults
- aged 21-45 years
- main household shopper (responsible for >50% of the household grocery shopping)
- shopping at a grocery store at least once a week
- owner of a smartphone (iPhone or Android) with internet access
- willingness to be randomized into one of the two groups.
Exclusion Criteria:
- Use of other apps
- Participating in weight loss programs
- Pregnant women
- Individuals with chronic health conditions
- Individuals with reported food allergies
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Smartphone Application
Participants will have access to a smartphone application that provides a healthy shopping list based on requirements, budget and discounts to improve dietary practices and weight
|
The smartphone Application generates a shopping list for participants, based on a low caloric diet (energy requirements minus 500 kcals), taking into consideration the Dietary Guidelines for Americans' recommendations and also considering the available budget for each shopping event and the weekly discounts from major supermarkets.
|
Active Comparator: Traditional Nutritional Counseling
Participants will participant in a face-to-face counseling session with a registered dietitian.
|
Participants will have a face-to-face counseling session with a registered dietitian, who will provide recommendations for a low caloric diet (energy requirements minus 500 kcals) using the food group sheets from the Dietary Guidelines for Americans.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the frequency of food intake
Time Frame: 8 weeks
|
A Food frequency questionnaire was completed by participants at baseline and end of study.
It includes the frequency of consumption of the following food groups: fruits, vegetables, starchy vegetables, refined and whole grains, legumes, healthy proteins, red meats, cold cuts and cured meats, whole-fat and low-fat dairy products, 100% fruit juices, and sugar-sweetened beverages.
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8 weeks
|
Change in food intake
Time Frame: 8 weeks
|
Three 24-h recalls were completed by participants at baseline and end of study.
The consumption of the following food groups was analyzed: fruits, vegetables, starchy vegetables, refined and whole grains, legumes, healthy proteins, red meats, cold cuts and cured meats, whole-fat and low-fat dairy products, 100% fruit juices, and sugar-sweetened beverages.
|
8 weeks
|
Change in foods selection
Time Frame: 8 weeks
|
Grocery receipts were evaluated at baseline and end of study for changes in food purchase of the following food groups: fruits, vegetables, whole grains, 100% fruit juices, and sugar-sweetened beverages.
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8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in weight
Time Frame: 8 weeks
|
Weight will be assessed at baseline and end of study
|
8 weeks
|
Feasibility
Time Frame: 8 weeks
|
Participants completed a questionnaire with 3 questions about feasibility, in which they rated each item using a five point Liker scale ranging from strongly agree (5 points) to strongly disagree (1 point): (1) easiness to use the App; (2) easiness to learn how to use the App; and (3) easiness how to find information in the App.
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8 weeks
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Usability
Time Frame: 8 weeks
|
Participants completed a questionnaire with 1 question about usability: times the App was used.
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8 weeks
|
Satisfaction
Time Frame: 8 weeks
|
Participants completed a questionnaire with 3 questions about their satisfaction with the App, in which they rated each item using a five point Liker scale ranging from strongly agree (5 points) to strongly disagree (1 point).
These items were: (1) satisfaction with information provided; (2) likenesses of re-using the app; (3) overall likeness and rating of the App.
|
8 weeks
|
Acceptability
Time Frame: 8 weeks
|
Participants completed a questionnaire with 3 questions about the acceptability of the App, in which they rated each item using a five point Liker scale ranging from strongly agree (5 points) to strongly disagree (1 point).
These items were: (1) attractiveness of the App; (2) comfortable using the app; (3) overall likeness about the layout and screen of the App.
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8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cristina Palacios, PhD, Nutrition Program, School of Public Health, Medical Sciences Campus, University of Puerto Rico
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)
January 13, 2016
Primary Completion (Actual)
April 30, 2016
Study Completion (Actual)
April 30, 2016
Study Registration Dates
First Submitted
March 7, 2017
First Submitted That Met QC Criteria
March 7, 2017
First Posted (Actual)
March 13, 2017
Study Record Updates
Last Update Posted (Actual)
March 13, 2017
Last Update Submitted That Met QC Criteria
March 7, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- A4540515
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No plan yet
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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