ClinicalTrials.gov
ClinicalTrials.gov Menu

Pilot Trial to Test a Nutrition Application for Making Smart and Healthy Choices

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03078660
Recruitment Status : Completed
First Posted : March 13, 2017
Last Update Posted : March 13, 2017
Sponsor:
Information provided by (Responsible Party):
University of Puerto Rico

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diet Modification Obesity Behavioral: Smartphone Application Behavioral: Traditional Nutritional Counseling Not Applicable

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  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Pilot Trial to Test a Nutrition Application for Making Smart and Healthy Choices When Purchasing Food in Grocery Stores
Actual Study Start Date : January 13, 2016
Actual Primary Completion Date : April 30, 2016
Actual Study Completion Date : April 30, 2016

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
Behavioral: Smartphone Application
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.
Behavioral: Traditional Nutritional Counseling
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Change in weight [ Time Frame: 8 weeks ]
    Weight will be assessed at baseline and end of study

  2. 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.

  3. Usability [ Time Frame: 8 weeks ]
    Participants completed a questionnaire with 1 question about usability: times the App was used.

  4. 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.

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03078660


Locations
Puerto Rico
University of Puerto Rico, Medical Sciences Campus (UPR-MSC)
San Juan, Puerto Rico, 00936-5067
Sponsors and Collaborators
University of Puerto Rico
Investigators
Principal Investigator: Cristina Palacios, PhD Nutrition Program, School of Public Health, Medical Sciences Campus, University of Puerto Rico

Responsible Party: University of Puerto Rico
ClinicalTrials.gov Identifier: NCT03078660     History of Changes
Other Study ID Numbers: A4540515
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan yet

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No