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

NCT ID: NCT03078660

Last Updated: 2017-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-13
• Study Completion Date: 2016-04-30

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.

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.

Conditions

Diet Modification; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Smartphone Application

Intervention Type: BEHAVIORAL

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.

Traditional Nutritional Counseling

Participants will participant in a face-to-face counseling session with a registered dietitian.

Group Type: ACTIVE_COMPARATOR

Traditional Nutritional Counseling

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Puerto Rico

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cristina Palacios, PhD

Role: PRINCIPAL_INVESTIGATOR

Nutrition Program, School of Public Health, Medical Sciences Campus, University of Puerto Rico

Locations

University of Puerto Rico, Medical Sciences Campus (UPR-MSC)

San Juan, , Puerto Rico

Countries

Puerto Rico

Other Identifiers

A4540515

Identifier Type: -

Identifier Source: org_study_id