NCT03410472

Brief Summary

Over nutrition has led to an increasing overweight and obese population. Maintaining a calorie deficit can be difficult causing many patients to be unsuccessful at weight loss attempts. There are many smart phone applications that are labeled as weight loss aids, MyFitnessPal™ being one of these applications. MyFitnessPal ™ assists users to help record calorie intake to maintain a balanced caloric intake and to avoid over nutrition Primary Hypothesis: This study is testing the hypothesis that subjects using a smart phone calorie calculator with intervention will have a greater body fat percentage loss in 8 weeks when compared to the control group. Secondary Hypothesis: Subjects using a smart phone calorie calculator with intervention will report improved self-body image in 8 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable obesity

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

October 12, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 16, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 25, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2018

Completed
Last Updated

November 9, 2018

Status Verified

November 1, 2018

Enrollment Period

12 months

First QC Date

November 16, 2017

Last Update Submit

November 8, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Body Fat Percentage

    This will be tested using dual-x ray absorptiometry

    Week 1 and Week 8

Secondary Outcomes (4)

  • Change in Lean Body Mass

    Week 1 and Week 8

  • Change in Body Mass Index

    Week 1 and Week 8

  • Change in Systolic and Diastolic Blood Pressure

    Week 1 and Week 8

  • Change in BSQ-16

    Week 1 and Week 8

Study Arms (2)

Web based diet application

EXPERIMENTAL

This arm entails the subject to record their diet into an online web program to monitor calories. The calorie goal will be given to the subjects in this group prior to the study based on dual x-ray absorptiometry test that will test resting metabolic rate.

Behavioral: Web based diet application

Control

NO INTERVENTION

This group will have body composition tested at week 1 and then repeat this test at 8 weeks having no intervention.

Interventions

This group will be asked to record their diets for 8 weeks after being told an approximate calorie goal. This group will receive weekly emails with tips on how to eat healthy

Web based diet application

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • greater than 25 body mass index, must own a smart phone

You may not qualify if:

  • currently using any other diet intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Institute of Technology

Old Westbury, New York, 11568, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Patricia Happel, DO

    New York Institute of Technology College of Osteopathic Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Only the individual performing the outcome measures will me masked to the assignment of the subjects.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a randomized parallel design study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2017

First Posted

January 25, 2018

Study Start

October 12, 2017

Primary Completion

October 2, 2018

Study Completion

October 2, 2018

Last Updated

November 9, 2018

Record last verified: 2018-11

Locations