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Simplifying Diet Tracking in a Digital Weight Loss Intervention

22 mai 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

328

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • California
      • Palo Alto, California, États-Unis, 94304
        • Stanford University School of Medicine

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Simplified (Track Red Zone Foods)
Simplified + Core
Comportemental: Simplified Dietary Self-Monitoring
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.
Comportemental: Core Behavioral Weight Loss Intervention
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.
Expérimental: Detailed (Track All Foods/Calories)
Detailed + Core
Comportemental: Core Behavioral Weight Loss Intervention
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.
Comportemental: Detailed Dietary Self-Monitoring
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Weight Change from Baseline to 12 Months
Délai: Baseline, 12 Months
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)
Baseline, 12 Months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Weight Change from Baseline to 1 Month
Délai: Baseline, 1 Month
mean change in body weight (kg); assessed objectively via e-scale using standardized procedures
Baseline, 1 Month
Weight Change from Baseline to 6 Months
Délai: Baseline, 6 Months
mean change in body weight (kg); assessed objectively via e-scale using standardized procedures
Baseline, 6 Months
Weight Change from Baseline to 18 Months
Délai: Baseline, 18 Months
mean change in body weight (kg); assessed objectively via e-scale using standardized procedures
Baseline, 18 Months
Caloric Intake Change from Baseline to 12 Months
Délai: Baseline, 12 Months
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
Baseline, 12 Months
Diet Quality Change from Baseline to 12 Months
Délai: Baseline, 12 Months
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
Baseline, 12 Months
Step Count Change from Baseline to 12 Months
Délai: Baseline, 12 Months
mean change in step count; assessed objectively via activity tracker
Baseline, 12 Months
Health-Related Quality of Life (Physical Health) Change from Baseline to 12 Months
Délai: Baseline, 12 Months
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
Baseline, 12 Months
Health-Related Quality of Life (Mental Health) Change from Baseline to 12 Months
Délai: Baseline, 12 Months
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
Baseline, 12 Months
Engagement in Self-Monitoring Dietary Intake
Délai: daily during the 12-month intervention
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
daily during the 12-month intervention
Engagement in Self-Monitoring Weight
Délai: daily during the 12-month intervention
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
daily during the 12-month intervention
Engagement in Self-Monitoring Steps
Délai: daily during the 12-month intervention
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
daily during the 12-month intervention

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Stanford University

Les enquêteurs

  • Chercheur principal: Michele L. Patel, PhD, Stanford University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 mai 2027

Achèvement primaire (Estimé)

30 avril 2030

Achèvement de l'étude (Estimé)

31 octobre 2030

Dates d'inscription aux études

Première soumission

14 mai 2026

Première soumission répondant aux critères de contrôle qualité

14 mai 2026

Première publication (Réel)

22 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

28 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

22 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 87051

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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.

Délai de partage IPD

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).

Critères d'accès au partage IPD

Publicly available.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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