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Simplifying Diet Tracking in a Digital Weight Loss Intervention

22 de maio de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

328

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Estados Unidos
    • California
      • Palo Alto, California, Estados Unidos, 94304
        • Stanford University School of Medicine

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Simplified (Track Red Zone Foods)
Simplified + Core
Comportamental: 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.
Comportamental: 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.
Experimental: Detailed (Track All Foods/Calories)
Detailed + Core
Comportamental: 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.
Comportamental: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Weight Change from Baseline to 12 Months
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Weight Change from Baseline to 1 Month
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Stanford University

Investigadores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de maio de 2027

Conclusão Primária (Estimado)

30 de abril de 2030

Conclusão do estudo (Estimado)

31 de outubro de 2030

Datas de inscrição no estudo

Enviado pela primeira vez

14 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

14 de maio de 2026

Primeira postagem (Real)

22 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

28 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

22 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 87051

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano 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.

Prazo de Compartilhamento de 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).

Critérios de acesso de compartilhamento IPD

Publicly available.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CIF

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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