Weight Loss and Healthy Diet Through Mobile Phone-enabled Social Interactions
2015年8月31日 更新者:Christopher Sciamanna, MD, MPH、Milton S. Hershey Medical Center
Enhancing the Sustainability of Weight Loss and Healthy Diet Through Mobile Phone-enabled Social Interactions
A randomized controlled trial comparing the effects of the social-enabled internet weight loss and diet change intervention with the delayed treatment group for 3 months.
We will study the effect of adding social interactions and supports to an Internet weight loss and diet change intervention.
The website intervention will have action planning with social interactions and support features for sharing, reusing, recommending, and discussing strategies for improving habits.
We hypothesize that the intervention group with access to the website will lose more weight than the delayed treatment group after three months.
調査の概要
詳細な説明
Over the past two decades a very simple, low-cost and consistently effective intervention has been developed that we believe has potential to be disseminated online in primary care.
The intervention, "action planning" (AP), is also known as "if-then planning" or "implementation intentions".
Action Planning is one element of the process of self-regulation (Wing et al 2006; Luszczynska et al 2007), in which individuals identify (1) situations that challenge their ability to perform a behavior and (2) make a specific plan for what they will do when the situation is next encountered.
Luszczynska and colleagues observed that adding a single session of action planning onto a portion-controlled meal intervention increased the weight lost from 2.1 kg to 4.2 kg (Luszczynska et al 2007).
A meta-analysis of 94 studies using AP, nearly all of which included a single-dose, observed a mean effect size of Cohen's d=.65, consistent with a medium to large effect.
Studies of repeated doses appear to have even greater effects (Chapman and Armitage 2010).
Dr. Sciamanna recently completed a pilot feasibility study in which 53 subjects used an AP intervention for weight loss for 2 months.
All subjects attended a 1-hour introductory session about the use of portion-controlled meals and pedometers.
Subjects were then emailed one AP writing prompt each day, representing one of the 21 of the most common barriers to weight control (Bond et al 2001).
Despite receiving no personalized feedback, over 2 months the subjects wrote action plans, on an average of 4.2 days per week.
After 2 months, the average weight loss was 7.7 pounds.
These adherence levels, though short-term, are greater than typical web-based weight control interventions included in a recent Cochrane review (Wieland 2012).
This pilot study suggests that this low-cost intervention approach may have unusual levels of fidelity.
Even though the average activities of user engagement with AP is quite high in the first two months, there is a slight decline toward the third month.
In focus group discussions after a pilot conducted by Dr. Sciamanna in the Philadelphia area, participants of the pilot indicated consistent difficulties in coming up with ideas for habits that might be useful.
These observations motivates this proposed study.
研究の種類
介入
入学 (実際)
102
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Pennsylvania
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Hershey、Pennsylvania、アメリカ、17033
- Penn State Milton S. Hershey Medical Center
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
21年~65年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Between 21-65 years old
- English speaking
- BMI from 27-50 kg/m2
- Access to the Internet at home or work for most days of the week
- Have current service for a smart phone with a camera and texting capability
- Able to use mobile phone to take a picture and send it to someone
- Able to use mobile phone to look for information on the internet using a search engine (such as Google)
- Able to use mobile phone to send and receive text messages
- Able to use mobile phone to send and receive emails
- Access to a scale at home
Exclusion Criteria:
- Pregnant or planning to become pregnant in the next 3 months
- Planning on moving out of the area in the next 6 months
- Weigh more than 300 pounds
- Participating in an internet or community weight loss program
- Taking medication, prescription or over the counter for weight loss
- Doctor has said you have a heart condition and should only do physical activity recommended by a doctor
- Feel pain in chest when doing physical activity
- In the past month feel pain in chest when not doing physical activity
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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:なし(オープンラベル)
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:Website
Group will be asked to complete a daily plan online for specific situations that tempt people to overeat.
The website can be accessed online using a computer or smart phone and will allow participants to view others' plans.
Participants will also be asked to enter their weight online every week.
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Website will have action planning with social interactions and support features for sharing, reusing, and recommending strategies for improving habits.
Participants will record their weight and complete surveys online.
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アクティブコンパレータ:Usual Care
Group will be given access to the online intervention after the 3-month study ends.
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Participants will record their weight and complete surveys online.
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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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Body Weight
時間枠:3 months
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Body weight will be measured by a research assistant using a portable, digital scale.
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3 months
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Demographics
時間枠:3 months
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We will measure age, gender, race and ethnicity, smoking status, education and other demographics, based on standard self-report.
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3 months
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Hospital and Anxiety Scale
時間枠:3 months
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This self-assessment scale has been found to be a reliable instruction for detecting states of depression and anxiety.
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3 months
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International Physical Activity Questionnaire
時間枠:3 months
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The survey comprises a set of 4 questionnaires.
The purpose of the questionnaires is to provide common instruments that can be used to obtain internationally comparable data on health-related physical activity.
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3 months
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Medications
時間枠:3 months
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We will measure dose and quantity of all prescribed medications based on standard self-report.
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3 months
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Motivation scale
時間枠:3 months
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This questionnaire asks participants how motivated they are to control their weight using non-comparative scaling.
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3 months
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Three Factor Eating Questionnaire
時間枠:3 months
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The questionnaire measures three dimensions of dietary restraint: cognitive restraint, disinhibition, perceived hunger.
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3 months
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Weight Loss Habits
時間枠:3 months
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This questionnaire asks participants to rate their frequency of use of weight loss habits using non-comparative scaling.
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3 months
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Adherence
時間枠:3 months
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We will examine daily journal completion data overall (mean and median) and as percentage.
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3 months
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Satisfaction
時間枠:3 months
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This questionnaire asks participants to provide feedback about the study.
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3 months
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Sedentary Behavior Questionnaire
時間枠:3 months
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3 months
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Well Being
時間枠:3 months
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3 months
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Weight Efficacy Questionnaire
時間枠:3 months
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3 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者:Christopher Sciamanna, MD, MPH、Milton S. Hershey Medical Center
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2013年10月1日
一次修了 (実際)
2014年11月1日
研究の完了 (実際)
2014年11月1日
試験登録日
最初に提出
2013年9月30日
QC基準を満たした最初の提出物
2013年9月30日
最初の投稿 (見積もり)
2013年10月8日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年9月1日
QC基準を満たした最後の更新が送信されました
2015年8月31日
最終確認日
2015年8月1日
詳しくは
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