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Assessing the Efficacy of Smartphone Calorie Calculator Application on Body Composition With and Without Intervention

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ClinicalTrials.gov Identifier: NCT03410472
Recruitment Status : Completed
First Posted : January 25, 2018
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
New York Institute of Technology

Tracking Information
First Submitted Date  ICMJE November 16, 2017
First Posted Date  ICMJE January 25, 2018
Last Update Posted Date November 9, 2018
Actual Study Start Date  ICMJE October 12, 2017
Actual Primary Completion Date October 2, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2018)
Change in Body Fat Percentage [ Time Frame: Week 1 and Week 8 ]
This will be tested using dual-x ray absorptiometry
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2018)
  • Change in Lean Body Mass [ Time Frame: Week 1 and Week 8 ]
    This will be tested using dual-x ray absorptiometry
  • Change in Body Mass Index [ Time Frame: Week 1 and Week 8 ]
    This will be tested using dual-x ray absorptiometry
  • Change in Systolic and Diastolic Blood Pressure [ Time Frame: Week 1 and Week 8 ]
    Blood pressure will be recorded using a manual sphygmometer
  • Change in BSQ-16 [ Time Frame: Week 1 and Week 8 ]
    This is a 16 question survey on body image
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessing the Efficacy of Smartphone Calorie Calculator Application on Body Composition With and Without Intervention
Official Title  ICMJE Assessing the Efficacy of Smart Phone Calorie Calculator Application on Body Composition With and Without Intervention
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.

Detailed Description

All subjects will read and sign an informed consent prior to participation in the study. The proposed study will be conducted at the Academic Health Care Center of the New York Institute of Technology, College of Osteopathic Medicine (Old Westbury, NY). Subjects will have 2 testing days where they will have to come into the Academic Health Care Center .

This study will consist of 30 participants and will last 8 weeks. Inclusion criteria will be male and female NYIT students between the ages of 18-35, a BMI ≥ 25.0, and own their own smart phone. All subjects will have their body composition measured, blood pressure, and pulse measured before and at the end of the study.

Participants will be randomly assigned by gender into two groups. Group one, the control group, will consist of 5 males, and 5 females. Group two, the intervention group, will consist of 10 males, and 10 females. At the start of the study both groups will have blood pressure, and pulse recorded, along with a duel x-ray absorptiometry body scan to measure resting metabolic rate (RMR) and body composition (lean body mass, body fat, BMI). At that time both groups will also receive the "NYC My Plate Planner", and the "USDA Dietary Guidelines for Americans 2015-2020".

Both Groups will be instructed to use the MyFitnessPal smart phone weight loss application to record calorie intake based on their resting metabolic rate determined by the body scan. Additionally both groups will initially receive a validated confidential survey on body image. The control group will not be contacted again until the end of the 8 weeks study. The intervention group will be contacted every week by email to discuss their weekly calorie intake, and compliance with the program. At week 4 each person in the intervention group will receive a phone call to discuss their calorie intake, and address any problems, or concerns. At the end of week 8 both groups will receive a follow up validated confidential survey on body image. At that time both groups will also return for a follow-up blood pressure recording, pulse recording, and body composition scan to measure resting metabolic rate and body composition (lean body mass, body fat, BMI).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This is a randomized parallel design study
Masking: Single (Outcomes Assessor)
Masking Description:
Only the individual performing the outcome measures will me masked to the assignment of the subjects.
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE Behavioral: Web based diet application
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
Study Arms  ICMJE
  • Experimental: Web based diet application
    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.
    Intervention: Behavioral: Web based diet application
  • No Intervention: Control
    This group will have body composition tested at week 1 and then repeat this test at 8 weeks having no intervention.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 24, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2, 2018
Actual Primary Completion Date October 2, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • currently using any other diet intervention
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03410472
Other Study ID Numbers  ICMJE BHS-1309
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party New York Institute of Technology
Study Sponsor  ICMJE New York Institute of Technology
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Patricia Happel, DO New York Institute of Technology College of Osteopathic Medicine
PRS Account New York Institute of Technology
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP