Sustainable Weight Loss Study: Nutrition Support Tools and Weight Loss Among Obese People
調査の概要
状態
条件
詳細な説明
Obesity is a major public health burden. Weight loss among obese participants may improve future health outcomes and financial burden to the healthcare system and employers.
The effect of personalized meal planning and online food purchasing and delivery on weight loss and management is unknown.
Design: This trial is an online, three-arm randomized trial to compare a meal planning and telenutrition tool, a meal planning tool only, and MyPlate optimization.
Participants will be assigned to randomly assigned in a 1:1:1 ratio to one of the three groups.
Participants will follow the intervention for 6 months after randomization and will be followed for an additional 1.5 years after randomization.
Participants will report dietary behavior and weight at baseline and each month of the intervention (6 months), 12 months, 18 months, and 24 months.
Population Approximately 300 participants will be enrolled and randomized (100 per arm). Participants will be adults living in New York state who are obese (at least a BMI of 30 kg/m2).
Outcomes Primary outcome: weight change after 6 months Other outcomes: waist circumference; blood pressure, dietary changes, cooking, meal planning, and eating out frequencies
研究の種類
入学 (予想される)
段階
- 適用できない
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:
BMI ≥ 30 kg/m2 Male or female 18 or older Non-institutionalized Able and willing to provide informed consent Willing to change diet for 3 months Has access to a scale to weigh themselves Lives in NY state
Exclusion Criteria:
Refuse or are unable to provide informed consent to participate in the study Undergoing active cancer treatment Has type 1 or 2 diabetes Stage 3+ CKD or kidney failure Are pregnant or breastfeeding, have given birth in the last three months, or are planning to be pregnant in the next 3 months Report of congestive heart failure Diagnosed with an eating disorder (e.g. anorexia nervosa or bulimia nervosa) Current or former Zipongo users
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Nutrition and food purchasing tool + telenutrition
Participants will use an online nutrition and food purchasing tool in addition to telenutrition.
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Participants will be asked to use a meal planning and food purchasing feature regularly (at least once every two weeks) and schedule appointments with a registered dietitian.
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アクティブコンパレータ：Nutrition and food purchasing tool
Participants will use an online nutrition and food purchasing tool.
|
Participants will be asked to use a meal planning and food purchasing feature regularly (at least once every two weeks).
|
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アクティブコンパレータ：Nutrition education tool
Participants will be exposed to an online nutrition education materials.
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Participants will be asked to review nutrition education materials 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 |
|---|---|---|
|
Weight change
時間枠：Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
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Weight will be measured using a scale and self-reported.
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Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
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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 |
|---|---|---|
|
Waist circumference
時間枠：Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
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Waist circumference will be measured using a tape measure and self-reported.
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Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
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Blood pressure
時間枠：Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
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Blood pressure will be a self-reported assessment at a clinic or pharmacy.
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Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
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Change in diet quality
時間枠：Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
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Diet quality will be assessed using a food frequency questionnaire.
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Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
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
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。