Simplifying Diet Tracking in a Digital Weight Loss Intervention
2026年5月22日 更新者：Michele Patel、Stanford University
Simplifying Dietary Self-Monitoring in a Digital Weight Loss Intervention
The purpose of this study is to compare two approaches for tracking dietary intake in a 12-month fully digital weight loss intervention: (1) Simplified approach: track Red Zone Foods (e.g., foods high in calories and low in nutritional value) vs. (2) Detailed approach: track all foods and their corresponding calories. In essence, this is a head-to-head comparison of two tracking approaches; the investigators are evaluating whether weight loss is comparable over 12 months, or whether one approach will have greater weight loss.
The investigators will recruit 328 adults. Broadly, adults with overweight or obesity who live in the United States will be eligible. The weight loss intervention will last 12 months. All participants will be asked to track their dietary intake + body weight + steps daily as well as complete weekly behavioral lessons and action plans to promote healthy eating and physical activity. All study tasks will occur remotely. Assessment of body weight and survey measures will occur at the beginning of the trial ("baseline"), and at 1, 6, 12, and 18 months.
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
328
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。
研究連絡先
- 名前：Study Team
- 電話番号：650-549-7047
- メール：mlp9@stanford.edu
研究場所
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California
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Palo Alto、California、アメリカ、94304
- Stanford University School of Medicine
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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
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- adults (ages 18+ years)
- body mass index (BMI) 25.0 to 45.0 kg/m^2
- smartphone ownership
- willing to install a mobile app on personal smartphone
- access to a personal email account
- English or Spanish language proficiency
- interest in losing weight through behavioral strategies
- living in the United States
- willing to be randomized
Exclusion Criteria:
- concurrent enrollment in another weight management intervention
- loss of ≥5% weight in the past 6 months
- prior or planned bariatric surgery during the trial period
- current or planned pregnancy during the trial period, or recent pregnancy in the past 6 months
- currently breastfeeding or lactating
- current use of anti-obesity medications
- living with someone else participating in the study
- hospitalization for a mental health condition in the past 12 months
- inability to engage in moderate forms of physical activity akin to brisk walking
- medical or psychiatric contraindication (e.g., end stage renal disease, cancer, schizophrenia, dementia, use of steroids, use of antipsychotic medication)
- if an individual would be better suited for a more intensive or different type of intervention based on a health condition (e.g., individuals with history of an eating disorder or cardiovascular event, uncontrolled hypertension, or uncontrolled diabetes mellitus)
- investigator discretion for safety reasons
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：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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実験的：Simplified (Track Red Zone Foods)
Simplified + Core
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Participants randomized to receive this intervention are instructed to track their Red Zone Foods (i.e., foods high in calories and low in nutritional value) daily via a web-based checklist.
Participants receive a daily Red Zone Food goal.
All participants receive a 12-month core behavioral weight loss intervention consisting of the following: goal setting; daily self-monitoring of body weight & steps; weekly behavioral lessons and action plans to promote healthy eating and physical activity; and tailored feedback.
The intervention will be delivered remotely via email and/or text message.
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実験的：Detailed (Track All Foods/Calories)
Detailed + Core
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All participants receive a 12-month core behavioral weight loss intervention consisting of the following: goal setting; daily self-monitoring of body weight & steps; weekly behavioral lessons and action plans to promote healthy eating and physical activity; and tailored feedback.
The intervention will be delivered remotely via email and/or text message.
Participants randomized to receive this intervention are instructed to track all foods/drinks and their corresponding calories daily via a mobile app.
Participants receive a daily calorie goal.
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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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Weight Change from Baseline to 12 Months
時間枠：Baseline, 12 Months
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mean change in body weight (kg); assessed objectively via e-scale using standardized procedures (e.g., place the scale on a hard surface; collect weight in the morning, without clothing, prior to eating/drinking)
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Baseline, 12 Months
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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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Weight Change from Baseline to 1 Month
時間枠：Baseline, 1 Month
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mean change in body weight (kg); assessed objectively via e-scale using standardized procedures
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Baseline, 1 Month
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Weight Change from Baseline to 6 Months
時間枠：Baseline, 6 Months
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mean change in body weight (kg); assessed objectively via e-scale using standardized procedures
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Baseline, 6 Months
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Weight Change from Baseline to 18 Months
時間枠：Baseline, 18 Months
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mean change in body weight (kg); assessed objectively via e-scale using standardized procedures
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Baseline, 18 Months
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Caloric Intake Change from Baseline to 12 Months
時間枠：Baseline, 12 Months
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mean change in daily caloric intake (kilocalories); assessed via the Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24): 2 separate diet recalls per time point: 1 week day, 1 weekend day
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Baseline, 12 Months
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Diet Quality Change from Baseline to 12 Months
時間枠：Baseline, 12 Months
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mean change in diet quality; assessed via the Healthy Eating Index, calculated from ASA24 data; score range: 0 to 100, with higher scores indicating better diet quality
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Baseline, 12 Months
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Step Count Change from Baseline to 12 Months
時間枠：Baseline, 12 Months
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mean change in step count; assessed objectively via activity tracker
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Baseline, 12 Months
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Health-Related Quality of Life (Physical Health) Change from Baseline to 12 Months
時間枠：Baseline, 12 Months
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mean change in health-related quality of life (Physical Component Summary); assessed via the SF-36 survey; score range: 0 to 100, with higher scores indicating better quality of life
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Baseline, 12 Months
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Health-Related Quality of Life (Mental Health) Change from Baseline to 12 Months
時間枠：Baseline, 12 Months
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mean change in health-related quality of life (Mental Component Summary); assessed via the SF-36 survey; score range: 0 to 100, with higher scores indicating better quality of life
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Baseline, 12 Months
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Engagement in Self-Monitoring Dietary Intake
時間枠：daily during the 12-month intervention
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operationalized as average percentage of days in the 12-month intervention of self-monitoring dietary intake (Red Zone Foods for Simplified arm vs. all foods/calories for Detailed arm); assessed via e-checklist for Simplified arm and via app for Detailed arm; will report median (IQR) if data are non-normally distributed
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daily during the 12-month intervention
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Engagement in Self-Monitoring Weight
時間枠：daily during the 12-month intervention
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operationalized as average percentage of days in the 12-month intervention of self-monitoring body weight; assessed via e-scale; will report median (IQR) if data are non-normally distributed
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daily during the 12-month intervention
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Engagement in Self-Monitoring Steps
時間枠：daily during the 12-month intervention
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operationalized as average percentage of days in the 12-month intervention of self-monitoring steps; assessed via activity tracker; will report median (IQR) if data are non-normally distributed
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daily during the 12-month intervention
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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：Michele L. Patel, PhD、Stanford University
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 (推定)
2027年5月1日
一次修了 (推定)
2030年4月30日
研究の完了 (推定)
2030年10月31日
試験登録日
最初に提出
2026年5月14日
QC基準を満たした最初の提出物
2026年5月14日
最初の投稿 (実際)
2026年5月22日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月28日
QC基準を満たした最後の更新が送信されました
2026年5月22日
最終確認日
2026年5月1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
- 87051
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
The de-identified dataset and metadata will be made available through a public repository.
It will include the primary outcome (weight change), secondary outcomes, and participant level characteristics.
Data will be available in an Excel spreadsheet, whereby each row corresponds to a unique participant's data, and columns represent the different variables mentioned, by time point.
IPD 共有時間枠
The shared dataset and metadata will be preserved and made publicly available to share for at least 3 years following completion of the project, in accordance with NIH regulations.
They will be made available upon publication of the primary outcomes paper in a peer-reviewed journal, or at the end of the grant period (whichever comes first).
IPD 共有アクセス基準
Publicly available.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
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
いいえ
米国FDA規制機器製品の研究
いいえ
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。