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

8. november 2018 oppdatert av: New York Institute of Technology

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.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

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).

Studietype

Intervensjonell

Registrering (Faktiske)

20

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • New York
      • Old Westbury, New York, Forente stater, 11568
        • New York Institute of Technology

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 35 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

  • currently using any other diet intervention

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
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
Ingen inngripen: Control
This group will have body composition tested at week 1 and then repeat this test at 8 weeks having no intervention.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Body Fat Percentage
Tidsramme: Week 1 and Week 8
This will be tested using dual-x ray absorptiometry
Week 1 and Week 8

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Lean Body Mass
Tidsramme: Week 1 and Week 8
This will be tested using dual-x ray absorptiometry
Week 1 and Week 8
Change in Body Mass Index
Tidsramme: Week 1 and Week 8
This will be tested using dual-x ray absorptiometry
Week 1 and Week 8
Change in Systolic and Diastolic Blood Pressure
Tidsramme: Week 1 and Week 8
Blood pressure will be recorded using a manual sphygmometer
Week 1 and Week 8
Change in BSQ-16
Tidsramme: Week 1 and Week 8
This is a 16 question survey on body image
Week 1 and Week 8

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Patricia Happel, DO, New York Institute of Technology College of Osteopathic Medicine

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

12. oktober 2017

Primær fullføring (Faktiske)

2. oktober 2018

Studiet fullført (Faktiske)

2. oktober 2018

Datoer for studieregistrering

Først innsendt

16. november 2017

Først innsendt som oppfylte QC-kriteriene

24. januar 2018

Først lagt ut (Faktiske)

25. januar 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. november 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. november 2018

Sist bekreftet

1. november 2018

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • BHS-1309

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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