- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03410472
Assessing the Efficacy of Smartphone Calorie Calculator Application on Body Composition With and Without Intervention
Assessing the Efficacy of Smart Phone Calorie Calculator Application on Body Composition With and Without Intervention
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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).
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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New York
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Old Westbury, New York, Stati Uniti, 11568
- New York Institute of Technology
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- greater than 25 body mass index, must own a smart phone
Exclusion Criteria:
- currently using any other diet intervention
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
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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
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Nessun intervento: Control
This group will have body composition tested at week 1 and then repeat this test at 8 weeks having no intervention.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Body Fat Percentage
Lasso di tempo: Week 1 and Week 8
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This will be tested using dual-x ray absorptiometry
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Week 1 and Week 8
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Lean Body Mass
Lasso di tempo: Week 1 and Week 8
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This will be tested using dual-x ray absorptiometry
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Week 1 and Week 8
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Change in Body Mass Index
Lasso di tempo: Week 1 and Week 8
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This will be tested using dual-x ray absorptiometry
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Week 1 and Week 8
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Change in Systolic and Diastolic Blood Pressure
Lasso di tempo: Week 1 and Week 8
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Blood pressure will be recorded using a manual sphygmometer
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Week 1 and Week 8
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Change in BSQ-16
Lasso di tempo: Week 1 and Week 8
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This is a 16 question survey on body image
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Week 1 and Week 8
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Patricia Happel, DO, New York Institute of Technology College of Osteopathic Medicine
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- BHS-1309
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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