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Simplifying Diet Tracking in a Digital Weight Loss Intervention

22. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

328

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • California
      • Palo Alto, California, Forente stater, 94304
        • Stanford University School of Medicine

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Simplified (Track Red Zone Foods)
Simplified + Core
Atferdsmessig: 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.
Atferdsmessig: 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.
Eksperimentell: Detailed (Track All Foods/Calories)
Detailed + Core
Atferdsmessig: 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.
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Weight Change from Baseline to 12 Months
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Weight Change from Baseline to 1 Month
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Stanford University

Etterforskere

  • Hovedetterforsker: Michele L. Patel, PhD, Stanford University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. mai 2027

Primær fullføring (Antatt)

30. april 2030

Studiet fullført (Antatt)

31. oktober 2030

Datoer for studieregistrering

Først innsendt

14. mai 2026

Først innsendt som oppfylte QC-kriteriene

14. mai 2026

Først lagt ut (Faktiske)

22. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 87051

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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).

Tilgangskriterier for IPD-deling

Publicly available.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere