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.
調査の概要
詳細な説明
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).
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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New York
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Old Westbury、New York、アメリカ、11568
- New York Institute of Technology
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- greater than 25 body mass index, must own a smart phone
Exclusion Criteria:
- currently using any other diet intervention
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的: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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介入なし: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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Body Fat Percentage
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Lean Body Mass
時間枠: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
時間枠: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
時間枠: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
時間枠: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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協力者と研究者
捜査官
- 主任研究者:Patricia Happel, DO、New York Institute of Technology College of Osteopathic Medicine
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- BHS-1309
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Web based diet applicationの臨床試験
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