ENGAGED: E-Networks Guiding Adherence to Goals for Exercise and Diet (ENGAGED)
2016年11月10日 更新者：Bonnie Spring、Northwestern University
The ENGAGED study is a 12-month randomized controlled trial investigating different strategies to improve weight loss in overweight individuals.
All participants will receive an effective weight loss treatment: either self-guided or group formats.
All treatment will be provided in the Department of Preventive Medicine at Northwestern University.
Participants who receive the self-guided weight loss treatment will be provided with a weight loss manual that contains proven behavioral weight loss strategies.
Those participants who receive the group treatment will take part in 8 weekly, 90 minute group sessions in our clinic at 680 N. Lakeshore Dr., Chicago, IL 60048.
Some participants will also be assigned an individual coach, who will communicate with them regularly via phone, email, and/or text message for the duration of the study.
All participants must be willing and able to record food and beverage intake (either on a smartphone or on paper) and be willing to wear a small and unobtrusive physical activity measurement device for the first six-months of the study.
Additionally, all participants will be asked to attend 3 follow-up assessment visits at our clinic at months 3, 6 and 12 after the study begins.
Participants will be compensated for completing each of the 3 follow-up assessments.
All participants will be part of a team weight loss competition at 3 and 6 months with financial incentive to be split evenly among the winning team.
調査の概要
詳細な説明
The Diabetes Prevention Program (DPP) intensive lifestyle intervention is the gold standard weight loss treatment for adults with cardiometabolic risk factors.
Despite its efficacy, the DPP has not been widely adopted, because its 16 individual, face-to-face sessions with a specialist are considered too burdensome and expensive to be a sustainable program.
Attempts to reduce cost by decreasing session number have yielded greatly diminished weight loss.
Behavioral adherence to diet and activity goals declines and weight regain routinely begins once frequent face-to-face meetings cease.
The still unmet challenge of DPP implementation is how to reduce treatment intensity without excising the regular social support, accountability, and feedback that are essential to maintain adherence.
We hypothesize that it is feasible to implement DPP Intensive Lifestyle Treatment as effectively but twice as efficiently by using hand held technology to preserve feedback, accountability, and regular social support.
The smartphone-based technology system to be tested is guided by Carver and Scheier's control systems theory of self-regulation.
Initial formative research will upgrade the smartphone with engaging features that motivate participants to use the device to self-monitor and interact with a coach and peer support group.
Use of the finalized tool will be compared to usual recording on paper records in a preliminary 3-group randomized controlled trial (RCT) involving 96 obese adults.
By enabling peer support, accountability, and feedback on diet, physical activity, and weight loss goals continuously through the 6-month intervention period, the ENGAGED system is expected to enhance (1) behavioral adherence [operationalized by (a) self-monitoring of diet and activity and (b) attainment of diet and activity goals], and (2) weight loss.
An enabling technology that integrates specialist and peer support resources to improve treatment adherence could help to curtail the obesity epidemic by increasing the efficiency, feasibility, and reach of effective DPP lifestyle intervention.
研究の種類
介入
入学 (実際)
96
段階
- フェーズ2
- フェーズ 1
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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Illinois
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Chicago、Illinois、アメリカ、60611
- Northwestern University
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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
18年～60年 (大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- BMI between 30-40
- weight stable (not gained/lost more than 25 lbs in the past 6 months)
- not enrolled in any formal weight-loss program
- interested in losing weight
- willing and able to record dietary intake and weight for 6 months and wear an accelerometer
- willing to attend 8 weekly groups and 2 follow up assessments at the Northwestern Chicago campus
- expect to reside in the Chicago land area for the next 12 months
Exclusion Criteria:
- any unstable medical conditions (i.e. uncontrolled hypertension, diabetes, unstable angina pectoris, myocardial infarction, transient ischemic attack, cancer undergoing active treatment, a cerebrovascular accident within the past 6 months)
- history of insulin-dependent diabetes
- Crohn's disease
- diagnosis of obstructive sleep apnea requiring intervention
- required use of an assistive device for mobility (i.e. cane, wheelchair)
- BMI > 40
- hospitalization for a psychiatric disorder within the past 5 years
- those at risk for adverse cardiovascular events with moderate intensity activity
- those currently taking weight loss medication or committed to following an incompatible dietary regimen
- women who are pregnant, trying to get pregnant, or lactating
- Bulimia Nervosa
- suicide ideation
- current binge eating disorder
- those currently taking medications known to cause weight gain (i.e. Prednisone, Depakote, Diebeta, Diabinese, Cardura, Inderal, Zyprexa)
- current substance abuse or dependence
- plantar fasciitis
- current substance and/or alcohol dependence
- depression
- ADHD
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：階乗代入
- 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：Standard
Those randomized to the Standard condition will record everything they eat and will total their daily fat grams and calories on the "Keeping Track" form used in the DPP.
They will turn in their self-monitoring diaries and download their accelerometer (but not see those data) at weekly group sessions 1 through 8. Thereafter they will be expected to turn in paper data monthly, in person at the months 3 and 6 assessments and via mail, fax or e-mail for months 4 and 5. Accelerometer data will be downloaded at in-person visits.
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Those randomized to the Standard condition will record everything they eat and will total their daily fat grams and calories on the "Keeping Track" form used in the DPP.
They will turn in their self-monitoring diaries and download their accelerometer (but not see those data) at weekly group sessions 1 through 8. Thereafter they will be expected to turn in paper data monthly, in person at the months 3 and 6 assessments and via mail, fax or e-mail for months 4 and 5. Accelerometer data will be downloaded at in-person visits.
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実験的：Technology Supported condition
Those randomized to the Technology Supported condition will record dietary intake and weight on the smartphone, using the user-friendly, persuasive interface developed in Phase I.
They will be expected to enter their dietary intake into the smartphone daily throughout the day.
They will also be expected to enter their weight and to wear the accelerometer daily.
Time-stamped data from the smartphone will upload automatically to the study server throughout the day, where it will be visible to the lifestyle coach.
The participant's real-time diet, activity, and weight data relative to goals will also be visually depicted on the participant's smartphone.
The anticipated web platform will be developed specifically for the ENGAGED participants.
The coach will provide feedback on diet and activity self-monitoring and goal adherence at least weekly by phone, e-mail or text during weeks 1-8 and then at least monthly through the 6 month follow-up.
|
Those randomized to the Technology Supported condition will record dietary intake and weight on the smartphone, using the user-friendly, persuasive interface developed in Phase I.
They will be expected to enter their dietary intake into the smartphone daily throughout the day.
They will also be expected to enter their weight and to wear the accelerometer daily.
Time-stamped data from the smartphone will upload automatically to the study server throughout the day, where it will be visible to the lifestyle coach.
The participant's real-time diet, activity, and weight data relative to goals will also be visually depicted on the participant's smartphone.
The anticipated web platform will be developed specifically for the ENGAGED participants.
The coach will provide feedback on diet and activity self-monitoring and goal adherence at least weekly by phone, e-mail or text during weeks 1-8 and then at least monthly through the 6 month follow-up.
|
|
介入なし：Self-Guided
Participants in the Self-Guided condition will receive DPP DVDs (3 DVDs and 1 CD) at the beginning of the study.
This condition will not receive any direct dietary or physical activity interventions outside of the DVDs.
Although Self-Guided participants will be receiving the same 7% weight loss goal as the other two groups, they will not be receiving physical activity or diet goals.
The DVDs cover the initial 12-weekly sessions of the DPP, with the sessions portrayed by professional actors.
They will also be provided with a supplemental DVD which includes a manual for each of the 12 sessions.
They will also be giving the Keeping Track booklets and asked to record their diet and activity daily.
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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 |
時間枠 |
|---|---|
|
Weight loss
時間枠：3 months, 6 months, 12 months
|
3 months, 6 months, 12 months
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Behavioral adherence
時間枠：3 months, 6 months
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3 months, 6 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。
スポンサー
捜査官
- 主任研究者：Bonnie Spring, Ph.D.、Northwestern University
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Spring B, Pellegrini CA, Pfammatter A, Duncan JM, Pictor A, McFadden HG, Siddique J, Hedeker D. Effects of an abbreviated obesity intervention supported by mobile technology: The ENGAGED randomized clinical trial. Obesity (Silver Spring). 2017 Jul;25(7):1191-1198. doi: 10.1002/oby.21842. Epub 2017 May 11.
- Pellegrini CA, Duncan JM, Moller AC, Buscemi J, Sularz A, DeMott A, Pictor A, Pagoto S, Siddique J, Spring B. A smartphone-supported weight loss program: design of the ENGAGED randomized controlled trial. BMC Public Health. 2012 Nov 30;12:1041. doi: 10.1186/1471-2458-12-1041.
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
2011年7月1日
一次修了 (実際)
2013年5月1日
研究の完了 (実際)
2013年5月1日
試験登録日
最初に提出
2010年1月15日
QC基準を満たした最初の提出物
2010年1月15日
最初の投稿 (見積もり)
2010年1月18日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年11月11日
QC基準を満たした最後の更新が送信されました
2016年11月10日
最終確認日
2016年11月1日
詳しくは
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。