NCT03078660

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 13, 2017

Completed
Last Updated

March 13, 2017

Status Verified

March 1, 2017

Enrollment Period

4 months

First QC Date

March 7, 2017

Last Update Submit

March 7, 2017

Conditions

Diet ModificationObesity

Outcome Measures

Primary Outcomes (3)

  • Change in the frequency of food intake

    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.

    8 weeks

  • Change in food intake

    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

    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.

    8 weeks

Secondary Outcomes (5)

  • Change in weight

    8 weeks

  • Feasibility

    8 weeks

  • Usability

    8 weeks

  • Satisfaction

    8 weeks

  • Acceptability

    8 weeks

Study Arms (2)

Smartphone Application

EXPERIMENTAL

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

Traditional Nutritional Counseling

ACTIVE COMPARATOR

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

Behavioral: Traditional Nutritional Counseling

Interventions

Smartphone ApplicationBEHAVIORAL

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.

Smartphone Application
Traditional Nutritional CounselingBEHAVIORAL

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.

Traditional Nutritional Counseling

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Use of other apps
  • Participating in weight loss programs
  • Pregnant women
  • Individuals with chronic health conditions
  • Individuals with reported food allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

San Juan, 00936-5067, Puerto Rico

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Cristina Palacios, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 7, 2017

First Posted

March 13, 2017

Study Start

January 13, 2016

Primary Completion

April 30, 2016

Study Completion

April 30, 2016

Last Updated

March 13, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

No plan yet

Locations

PR(1)