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OverweightNCT07601061

Simplifying Diet Tracking in a Digital Weight Loss Intervention

A study testing Simplified Dietary Self-Monitoring, Detailed Dietary Self-Monitoring and Core Behavioral Weight Loss Intervention in people with Overweight and Obesity, run by Stanford University at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Overweight, Obesity, Weight Loss
What is being tested?
Simplified Dietary Self-Monitoring, Detailed Dietary Self-Monitoring and Core Behavioral Weight Loss Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
328 participants
Where
1 siteUnited States
Study dates
1 May 2027to 31 Oct 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • interest in losing weight through behavioral strategies
  • living in the United States
  • willing to be randomized

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Study Team contact

650-549-7047

mlp9@stanford.edu

United States1 site

  • Stanford University School of Medicine

    Palo Alto, California, 94304

Other trials in United States

About this study

Official title: 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.

Being tested
Simplified Dietary Self-Monitoring, Detailed Dietary Self-Monitoring, Core Behavioral Weight Loss Intervention
Keywords
digital intervention, behavioral intervention, behavior change, obesity, body weight, overweight, BMI, diet, tracking, track, self-monitoring, self-monitor, lifestyle, adults, intervention, weight loss, weight loss intervention, weight reduction, weight management, red zone foods
Medical subject headings
Overweight, Obesity, Weight Loss, Health Behavior, Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Simplified Dietary Self-MonitoringBehavioural

    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.

  • Detailed Dietary Self-MonitoringBehavioural

    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.

  • Core Behavioral Weight Loss InterventionBehavioural

    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.

Study groups in NCT07601061
Study groupRoleWhat they receive
Simplified (Track Red Zone Foods)ExperimentalSimplified + Core
Receives: Behavioral: Simplified Dietary Self-Monitoring; Behavioral: Core Behavioral Weight Loss Intervention
Detailed (Track All Foods/Calories)ExperimentalDetailed + Core
Receives: Behavioral: Detailed Dietary Self-Monitoring; Behavioral: Core Behavioral Weight Loss Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight Change from Baseline to 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)

    Measured: Baseline, 12 Months

Secondary outcomes (11)

  1. Weight Change from Baseline to 1 Month

    mean change in body weight (kg); assessed objectively via e-scale using standardized procedures

    Measured: Baseline, 1 Month

  2. Weight Change from Baseline to 6 Months

    mean change in body weight (kg); assessed objectively via e-scale using standardized procedures

    Measured: Baseline, 6 Months

  3. Weight Change from Baseline to 18 Months

    mean change in body weight (kg); assessed objectively via e-scale using standardized procedures

    Measured: Baseline, 18 Months

  4. Caloric Intake Change from Baseline to 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

    Measured: Baseline, 12 Months

  5. Diet Quality Change from Baseline to 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

    Measured: Baseline, 12 Months

  6. Step Count Change from Baseline to 12 Months

    mean change in step count; assessed objectively via activity tracker

    Measured: Baseline, 12 Months

  7. Health-Related Quality of Life (Physical Health) Change from Baseline to 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

    Measured: Baseline, 12 Months

  8. Health-Related Quality of Life (Mental Health) Change from Baseline to 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

    Measured: Baseline, 12 Months

  9. Engagement in Self-Monitoring Dietary Intake

    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

    Measured: daily during the 12-month intervention

  10. Engagement in Self-Monitoring Weight

    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

    Measured: daily during the 12-month intervention

  11. Engagement in Self-Monitoring Steps

    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

    Measured: daily during the 12-month intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2026
  2. Study start1 May 2027 (estimated)
  3. Primary completion30 Apr 2030 (estimated)
  4. Study completion31 Oct 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study is a two-arm, noninferiority trial that randomizes participants to either the Simplified or Detailed arm using a 1:1 allocation. The trial is powered to evaluate noninferiority between these two self-monitoring approaches for the primary outcome of 12-month weight change. Noninferiority is met if the upper limit of the confidence interval for the between-arm difference in weight change is below a 2.5 kg margin. If noninferiority is met, we will test for superiority.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
328 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07601061
Sponsor's protocol ID
87051
Status last verified
May 2026
First submitted
14 May 2026
Last updated
28 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Simplified Dietary Self-Monitoring, Detailed Dietary Self-Monitoring and Core Behavioral Weight Loss Intervention in people with Overweight and Obesity, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Team (650-549-7047, mlp9@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight Change from Baseline to 12 Months (time frame: Baseline, 12 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07601061.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.

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