Phone Versus Clinical Approach to Weight Loss
Equivalent Weight Loss for Phone and Clinic Weight Management Programs
Weight loss and maintenance continues to be problematic for individuals who are overweight or obese. State-of-the-art treatment generally involves a behavioral weight loss clinic that emphasizes nutrition, physical activity, and lifestyle changes and is delivered face-to-face between health educators and small groups of participants. This delivery system is time consuming, expensive, and presents numerous barriers to the participant. We have developed a phone based delivery system that eliminates many of these barriers by substituting group conference calls for clinics and by delivering weight loss materials and products directly to the participant.
Hypothesis 1: We expect equivalent weight loss from baseline for phone and clinic groups and have defined equivalence as no greater than 4 kg difference between groups based on our pilot data and potential for clinical significance.
Hypothesis 2: During weight maintenance it is likely that participants will experience some weight re-gain. We expect both phone and clinic groups to re-gain a similar amount of weight and that weight for both groups at 18 months will be significantly less than baseline weights.
Hypothesis 3: We will complete a cost analysis to determine which delivery method is more economical. Specifically, we expect the phone delivery system to be more cost effective than that of the in-person clinics.
調査の概要
詳細な説明
Weight loss and maintenance continues to be problematic for individuals who are overweight or obese. State-of-the-art treatment is delivered face-to-face between care providers and small groups of participants and this is time consuming, expensive, and presents numerous barriers to the participant such as travel, conflict with work and home, need for child care, loss of anonymity, and others as well as the care provider such as office space, meeting rooms, inventory, etc. A pilot study of a phone based delivery system versus a traditional clinic has been completed with no difference in weight loss. The phone approach may eliminate many of the barriers of a traditional clinic by substituting conference calls for clinics and by delivering weight loss materials and products directly to the participant. In this fashion, the care provider and participants can reside in any location and receive the same information by conference phone call as that provided by clinic, and receive educational materials, weight management products, etc. by air or ground transportation.
This proposed investigation is a randomized, equivalency trial to test the effectiveness of a phone based weight management program compared to a traditional face-to-face clinic program for weight loss and weight maintenance. It is expected that at 6 months participants in the phone and clinic groups will show equivalent weight loss and that weight loss will be at least 10% lower than baseline. During weight maintenance some weight gain may occur. However, we expect both phone and clinic groups to gain a similar amount of weight and that weight for both groups at 18 months will be significantly less than baseline weights.
A formal cost analysis will be used to determine differences between phone and clinic approaches and extensive process analysis will be used to collect both qualitative and quantitative data to assess how well the programs were implemented as originally designed, challenges and barriers to effective implementation, initial and continual use of program specified activities, quality assurance measures, etc.
Relevance: If successful, the phone approach may eliminate many of the barriers inherent to the traditional face-to-face clinic, may be less expensive, and would potentially open weight management to any individual with access to a phone. We believe the likelihood of translation of this research to the public sector would seem reasonable and promising.
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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Kansas
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Lawrence、Kansas、アメリカ、66045
- Energy Balance Lab, The University of Kansas
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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:
- 18-65 years,
- BMI between 25 and 39.9,
- Clearance from PCP.
Exclusion Criteria:
- Research project within previous 6 months,
- Exercise > 500 kcal/week,
- Pregnancy,
- Serious medical risk,
- Eating disorders,
- Use of special diets.
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:防止
- 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 |
---|---|
実験的:Phone based weight management group
Group based weight management program delivered via conference calls
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To determine if weight loss is equivalent between individuals that complete weight loss meetings in person versus on the phone.
他の名前:
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実験的:Clinic based weight management group
Traditional clinical based group weight management program
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To determine if weight loss is equivalent between individuals that complete weight loss meetings in person versus on the phone.
他の名前:
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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 |
---|---|
Equivalent weight loss for phone and clinic groups.
時間枠:6 months
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6 months
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二次結果の測定
結果測定 |
時間枠 |
---|---|
Equal weight management/regain.
時間枠:12 months
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12 months
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Cost Analysis
時間枠:18 months
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18 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Joseph E Donnelly, EdD、University of Kansas
出版物と役立つリンク
一般刊行物
- Donnelly JE, Goetz J, Gibson C, Sullivan DK, Lee R, Smith BK, Lambourne K, Mayo MS, Hunt S, Lee JH, Honas JJ, Washburn RA. Equivalent weight loss for weight management programs delivered by phone and clinic. Obesity (Silver Spring). 2013 Oct;21(10):1951-9. doi: 10.1002/oby.20334. Epub 2013 May 25.
- Lambourne K, Washburn RA, Gibson C, Sullivan DK, Goetz J, Lee R, Smith BK, Mayo MS, Donnelly JE. Weight management by phone conference call: a comparison with a traditional face-to-face clinic. Rationale and design for a randomized equivalence trial. Contemp Clin Trials. 2012 Sep;33(5):1044-55. doi: 10.1016/j.cct.2012.05.014. Epub 2012 Jun 1.
研究記録日
主要日程の研究
研究開始
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
キーワード
その他の研究ID番号
- HSCL16529
- R01DK076063 (米国 NIH グラント/契約)
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