Assessing the Efficacy of Smartphone Calorie Calculator Application on Body Composition With and Without Intervention
1 other identifier
interventional
20
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Oct 2017
Shorter than P25 for not_applicable obesity
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
November 16, 2017
CompletedFirst Posted
Study publicly available on registry
January 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 2, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 2, 2018
CompletedNovember 9, 2018
November 1, 2018
12 months
November 16, 2017
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
EXPERIMENTALThis 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.
Control
NO INTERVENTIONThis 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
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patricia Happel, DO
New York Institute of Technology College of Osteopathic Medicine
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
- 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