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Completed

NCT Number: NCT03078660

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

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.

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Key information

Conditions

Diet Modification Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

San Juan, 00936-5067, Puerto Rico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smartphone Application

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

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Puerto Rico

Other

Registry information

Official study title

Pilot Trial to Test a Nutrition Application for Making Smart and Healthy Choices When Purchasing Food in Grocery Stores

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 13, 2017
Registry last updated
Mar 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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