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CompletedNCT05715242Updated Aug 5, 2026Results posted

Ignite Pilot: Goal Setting in a Digital Weight Loss Intervention

An interventional study of Core Behavioral Weight Loss Intervention and Easier Step Goal in Obesity, Overweight and Weight Loss, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-05.

Sponsored by Stanford University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this pilot trial is to learn about the optimal intensity level of goals in a digital weight loss intervention among adults with overweight or obesity. The main questions of the study are to assess the feasibility and acceptability of different goal intensities across four domains (calorie goal, step goal, eating window goal, red zone food goal).

The investigators will recruit 32 total participants to the trial. Recruitment will occur through remote channels. Interested individuals will be directed to an online screening questionnaire; those who are eligible will then be invited to attend an initial remote session with study personnel to ensure interest and eligibility in the study. The weight loss intervention will last 10 weeks, and all participants will receive a "core" treatment consisting of self-monitoring weight, food intake, and steps (all via digital tools provided by the study team), along with behavioral lessons, action plans, and tailored feedback. Depending on which group participants are assigned to in the study, individuals will receive either a more or less challenging goal across the four domains. All study tasks will occur remotely, thus, participants will never come in-person for any tasks. Assessment of body weight and other measures will occur at the beginning of the trial ("baseline"), and at 4 weeks and 10 weeks.

The investigators will use the Multiphase Optimization Strategy (MOST) framework to identify which of the goal intensity levels result in meaningful engagement and weight loss. The current study is the first step towards answering this question; it is designed as a pilot factorial trial, which focuses on feasibility and acceptability. In total, there will be 16 treatment conditions.

02

Conditions studied

  • Obesity
  • Overweight
  • Weight Loss
  • Health Behavior

Keywords

  • weight loss
  • Multiphase Optimization Strategy
  • behavioral intervention
  • factorial trial
  • goal setting
  • time-restricted eating
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 32 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • adults (ages 18+ years)
  • body mass index (BMI) 25.0 to 45.0 kg/m\^2
  • smartphone ownership
  • willingness to install the Fitbit mobile app on their phone
  • access to a personal email account
  • English language proficiency
  • interest in losing weight through behavioral strategies
  • living in the United States

Exclusion criteria

Exclusion Criteria:

  • concurrent enrollment in another weight management intervention
  • loss of ≥10 lbs. in the past 6 months
  • current use of a weight loss medication
  • prior or planned bariatric surgery
  • current or planned pregnancy in the trial period
  • currently breastfeeding
  • lives 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 (assessed by the Physical Activity Readiness Questionnaire)
  • if weight loss is contraindicated or might be impacted by a condition or medication (e.g., end stage renal disease, cancer, schizophrenia, dementia, steroids, anti-psychotics)
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Condition 1

    Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (easier)

    Behavioral: Core Behavioral Weight Loss Intervention · Behavioral: Easier Step Goal · Behavioral: Easier Calorie Goal · Behavioral: Easier Eating Window Goal · Behavioral: Easier Red Zone Food Goal

  • Experimental
    Condition 2

    Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (harder)

    Behavioral: Core Behavioral Weight Loss Intervention · Behavioral: Easier Step Goal · Behavioral: Easier Calorie Goal · Behavioral: Easier Eating Window Goal · Behavioral: Harder Red Zone Food Goal

  • Experimental
    Condition 3

    Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (easier)

    Behavioral: Core Behavioral Weight Loss Intervention · Behavioral: Easier Step Goal · Behavioral: Easier Calorie Goal · Behavioral: Harder Eating Window Goal · Behavioral: Easier Red Zone Food Goal

  • Experimental
    Condition 4

    Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (harder)

    Behavioral: Core Behavioral Weight Loss Intervention · Behavioral: Easier Step Goal · Behavioral: Easier Calorie Goal · Behavioral: Harder Eating Window Goal · Behavioral: Harder Red Zone Food Goal

  • Experimental
    Condition 5

    Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (easier)

    Behavioral: Core Behavioral Weight Loss Intervention · Behavioral: Harder Step Goal · Behavioral: Easier Calorie Goal · Behavioral: Easier Eating Window Goal · Behavioral: Easier Red Zone Food Goal

  • Experimental
    Condition 6

    Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (harder)

    Behavioral: Core Behavioral Weight Loss Intervention · Behavioral: Harder Step Goal · Behavioral: Easier Calorie Goal · Behavioral: Easier Eating Window Goal · Behavioral: Harder Red Zone Food Goal

  • Experimental
    Condition 7

    Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (easier)

    Behavioral: Core Behavioral Weight Loss Intervention · Behavioral: Harder Step Goal · Behavioral: Easier Calorie Goal · Behavioral: Harder Eating Window Goal · Behavioral: Easier Red Zone Food Goal

  • Experimental
    Condition 8

    Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (harder)

    Behavioral: Core Behavioral Weight Loss Intervention · Behavioral: Harder Step Goal · Behavioral: Easier Calorie Goal · Behavioral: Harder Eating Window Goal · Behavioral: Harder Red Zone Food Goal

  • Experimental
    Condition 9

    Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (easier)

    Behavioral: Core Behavioral Weight Loss Intervention · Behavioral: Easier Step Goal · Behavioral: Harder Calorie Goal · Behavioral: Easier Eating Window Goal · Behavioral: Easier Red Zone Food Goal

  • Experimental
    Condition 10

    Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (harder)

    Behavioral: Core Behavioral Weight Loss Intervention · Behavioral: Easier Step Goal · Behavioral: Harder Calorie Goal · Behavioral: Easier Eating Window Goal · Behavioral: Harder Red Zone Food Goal

  • Experimental
    Condition 11

    Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (easier)

    Behavioral: Core Behavioral Weight Loss Intervention · Behavioral: Easier Step Goal · Behavioral: Harder Calorie Goal · Behavioral: Harder Eating Window Goal · Behavioral: Easier Red Zone Food Goal

  • Experimental
    Condition 12

    Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (harder)

    Behavioral: Core Behavioral Weight Loss Intervention · Behavioral: Easier Step Goal · Behavioral: Harder Calorie Goal · Behavioral: Harder Eating Window Goal · Behavioral: Harder Red Zone Food Goal

  • Experimental
    Condition 13

    Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (easier)

    Behavioral: Core Behavioral Weight Loss Intervention · Behavioral: Harder Step Goal · Behavioral: Harder Calorie Goal · Behavioral: Easier Eating Window Goal · Behavioral: Easier Red Zone Food Goal

  • Experimental
    Condition 14

    Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (harder)

    Behavioral: Core Behavioral Weight Loss Intervention · Behavioral: Harder Step Goal · Behavioral: Harder Calorie Goal · Behavioral: Easier Eating Window Goal · Behavioral: Harder Red Zone Food Goal

  • Experimental
    Condition 15

    Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (easier)

    Behavioral: Core Behavioral Weight Loss Intervention · Behavioral: Harder Step Goal · Behavioral: Harder Calorie Goal · Behavioral: Harder Eating Window Goal · Behavioral: Easier Red Zone Food Goal

  • Experimental
    Condition 16

    Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (harder)

    Behavioral: Core Behavioral Weight Loss Intervention · Behavioral: Harder Step Goal · Behavioral: Harder Calorie Goal · Behavioral: Harder Eating Window Goal · Behavioral: Harder Red Zone Food Goal

Interventions

  • BehavioralCore Behavioral Weight Loss Intervention

    All participants will receive a 10-week core behavioral weight loss treatment consisting of: self-monitoring weight, steps, and food intake; behavioral lessons; action plans; and tailored feedback. The intervention will be delivered remotely via email and digital tools (such as a smart scale, Fitbit activity tracker, and Fitbit app).

  • BehavioralEasier Step Goal

    Participants will receive an easier daily step goal.

  • BehavioralHarder Step Goal

    Participants will receive a more challenging daily step goal.

  • BehavioralEasier Calorie Goal

    Participants will receive an easier daily calorie goal.

  • BehavioralHarder Calorie Goal

    Participants will receive a more challenging daily calorie goal.

  • BehavioralEasier Eating Window Goal

    Participants will receive an easier daily eating window goal.

  • BehavioralHarder Eating Window Goal

    Participants will receive a more challenging daily eating window goal, akin to time-restricted eating.

  • BehavioralEasier Red Zone Food Goal

    Participants will receive an easier daily Red Zone Food goal.

  • BehavioralHarder Red Zone Food Goal

    Participants will receive a more challenging daily Red Zone Food goal.

06

What researchers measure

Primary outcomes

  1. (Feasibility) Engagement in Self-monitoring Body Weight

    average percentage of days in the 10-week intervention of self-monitoring weight (assessed objectively via smart scale); a benchmark of self-monitoring 75% of days would indicate feasibility

    Time frame: baseline to 10 weeks

  2. (Feasibility) Engagement in Self-monitoring Steps

    average percentage of days in the 10-week intervention of self-monitoring steps (assessed objectively via Fitbit activity tracker); a benchmark of self-monitoring 75% of days would indicate feasibility

    Time frame: baseline to 10 weeks

  3. (Feasibility) Engagement in Self-monitoring Dietary Intake

    average percentage of days in the 10-week intervention of self-monitoring dietary intake (assessed via Fitbit mobile app); a benchmark of self-monitoring 75% of days would indicate feasibility

    Time frame: baseline to 10 weeks

  4. (Acceptability) Would You Recommend the Weight Loss Program to a Friend Who is Trying to Lose Weight?

    1-item measure; a benchmark of 80% of participants answering "yes" would indicate acceptability

    Time frame: 10 weeks

Secondary outcomes

  1. (Feasibility) Retention Rate

    the proportion of participants who submitted a weight entry at 10 weeks; a benchmark of 80% would indicate feasibility

    Time frame: 10 weeks

  2. (Feasibility) Survey Completion Rate

    the proportion of participants who completed the web survey; a benchmark of 80% would indicate feasibility

    Time frame: baseline; 10 weeks

  3. (Feasibility) Goal Attainment of Calorie Goal

    average percentage of days in the 10-week intervention of meeting the daily calorie goal (assessed via Fitbit mobile app); a benchmark of 75% of days would indicate feasibility

    Time frame: baseline to 10 weeks

  4. (Feasibility) Goal Attainment of Step Goal

    average percentage of days in the 10-week intervention of meeting the daily step goal (assessed via Fitbit activity tracker); a benchmark of 75% of days would indicate feasibility

    Time frame: baseline to 10 weeks

  5. (Feasibility) Goal Attainment of Eating Window Goal

    average percentage of days in the 10-week intervention of meeting the daily eating window goal (assessed via survey); a benchmark of 75% of days would indicate feasibility

    Time frame: baseline to 10 weeks

  6. (Feasibility) Goal Attainment of Red Zone Food Goal

    average percentage of days (out of days instructed to track Red Zone Foods) in the 10-week intervention of meeting the daily Red Zone Food goal (assessed via survey); a benchmark of 75% of weeks would indicate feasibility

    Time frame: baseline to 10 weeks

  7. Weight

    percentage change in weight from baseline to 10 weeks (end of intervention); assessed objectively via smart scale

    Time frame: baseline to 10 weeks

07

Results

Posted May 16, 2025

Participant flow

Participants were enrolled into the Ignite study during a 7-week period between December 5, 2023 and January 23, 2024. The trial was fully remote, with recruitment of adults across the United States.

Participant flow — Overall Study
MilestoneCondition 1Condition 2Condition 3Condition 4Condition 5Condition 6Condition 7Condition 8Condition 9Condition 10Condition 11Condition 12Condition 13Condition 14Condition 15Condition 16
Started2222222222222222
Completed 4-week assessment2212222222222222
Completed2212212222222222
Not completed0010010000000000
Withdrew: Lost to follow-up0010010000000000

Outcome measures

Primary(Feasibility) Engagement in Self-monitoring Body Weight

average percentage of days in the 10-week intervention of self-monitoring weight (assessed objectively via smart scale); a benchmark of self-monitoring 75% of days would indicate feasibility

Time frame:
baseline to 10 weeks
Reported as:
Median · % of intervention days
(Feasibility) Engagement in Self-monitoring Body Weight
% of intervention daysAll Participants
(Feasibility) Engagement in Self-monitoring Body Weight89 (63 to 99)
Primary(Feasibility) Engagement in Self-monitoring Steps

average percentage of days in the 10-week intervention of self-monitoring steps (assessed objectively via Fitbit activity tracker); a benchmark of self-monitoring 75% of days would indicate feasibility

Time frame:
baseline to 10 weeks
Reported as:
Median · % of intervention days
(Feasibility) Engagement in Self-monitoring Steps
% of intervention daysStep Goal: EasierStep Goal: Harder
(Feasibility) Engagement in Self-monitoring Steps98 (87 to 100)99 (96 to 100)
Primary(Feasibility) Engagement in Self-monitoring Dietary Intake

average percentage of days in the 10-week intervention of self-monitoring dietary intake (assessed via Fitbit mobile app); a benchmark of self-monitoring 75% of days would indicate feasibility

Time frame:
baseline to 10 weeks
Reported as:
Median · % of intervention days
(Feasibility) Engagement in Self-monitoring Dietary Intake
% of intervention daysCalorie Goal: EasierCalorie Goal: Harder
(Feasibility) Engagement in Self-monitoring Dietary Intake54 (7 to 93)79 (41 to 92)
Primary(Acceptability) Would You Recommend the Weight Loss Program to a Friend Who is Trying to Lose Weight?

1-item measure; a benchmark of 80% of participants answering "yes" would indicate acceptability

Time frame:
10 weeks
Reported as:
Count of participants · Participants
(Acceptability) Would You Recommend the Weight Loss Program to a Friend Who is Trying to Lose Weight?
ParticipantsAll Participants
(Acceptability) Would You Recommend the Weight Loss Program to a Friend Who is Trying to Lose Weight?29
Secondary(Feasibility) Retention Rate

the proportion of participants who submitted a weight entry at 10 weeks; a benchmark of 80% would indicate feasibility

Time frame:
10 weeks
Reported as:
Count of participants · Participants
(Feasibility) Retention Rate
ParticipantsCalorie Goal: EasierCalorie Goal: HarderStep Goal: EasierStep Goal: HarderEating Window Goal: EasierEating Window Goal: HarderRed Zone Food Goal: EasierRed Zone Food Goal: Harder
(Feasibility) Retention Rate1416151515151515
Secondary(Feasibility) Survey Completion Rate

the proportion of participants who completed the web survey; a benchmark of 80% would indicate feasibility

Time frame:
baseline; 10 weeks
Reported as:
Count of participants · Participants
(Feasibility) Survey Completion Rate
ParticipantsAll Participants
(Feasibility) Survey Completion Rate30
Secondary(Feasibility) Goal Attainment of Calorie Goal

average percentage of days in the 10-week intervention of meeting the daily calorie goal (assessed via Fitbit mobile app); a benchmark of 75% of days would indicate feasibility

Time frame:
baseline to 10 weeks
Reported as:
Median · % of intervention days
(Feasibility) Goal Attainment of Calorie Goal
% of intervention daysCalorie Goal: EasierCalorie Goal: Harder
(Feasibility) Goal Attainment of Calorie Goal20 (6 to 54)29 (13 to 41)
Secondary(Feasibility) Goal Attainment of Step Goal

average percentage of days in the 10-week intervention of meeting the daily step goal (assessed via Fitbit activity tracker); a benchmark of 75% of days would indicate feasibility

Time frame:
baseline to 10 weeks
Reported as:
Median · % of intervention days
(Feasibility) Goal Attainment of Step Goal
% of intervention daysStep Goal: EasierStep Goal: Harder
(Feasibility) Goal Attainment of Step Goal51 (44 to 58)38 (35 to 45)
Secondary(Feasibility) Goal Attainment of Eating Window Goal

average percentage of days in the 10-week intervention of meeting the daily eating window goal (assessed via survey); a benchmark of 75% of days would indicate feasibility

Time frame:
baseline to 10 weeks
Reported as:
Median · % of intervention days
(Feasibility) Goal Attainment of Eating Window Goal
% of intervention daysEating Window Goal: EasierEating Window Goal: Harder
(Feasibility) Goal Attainment of Eating Window Goal78 (60 to 94)75 (47 to 93)
Secondary(Feasibility) Goal Attainment of Red Zone Food Goal

average percentage of days (out of days instructed to track Red Zone Foods) in the 10-week intervention of meeting the daily Red Zone Food goal (assessed via survey); a benchmark of 75% of weeks would indicate feasibility

Time frame:
baseline to 10 weeks
Reported as:
Median · % of intervention days
(Feasibility) Goal Attainment of Red Zone Food Goal
% of intervention daysRed Zone Food Goal: EasierRed Zone Food Goal: Harder
(Feasibility) Goal Attainment of Red Zone Food Goal65 (46 to 94)42 (0 to 63)
SecondaryWeight

percentage change in weight from baseline to 10 weeks (end of intervention); assessed objectively via smart scale

Time frame:
baseline to 10 weeks
Reported as:
Mean · % weight change
Weight
% weight changeCalorie Goal: EasierCalorie Goal: HarderStep Goal: EasierStep Goal: HarderEating Window Goal: EasierEating Window Goal: HarderRed Zone Food Goal: EasierRed Zone Food Goal: Harder
Weight-3.1 ± 3.7-4.9 ± 3.3-3.7 ± 3.8-4.4 ± 3.4-4.5 ± 2.6-3.6 ± 4.3-4.3 ± 2.8-3.8 ± 4.2

Adverse events

Collected over From randomization until end of the 10-week intervention. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Condition 10/2 (0%)0/2 (0%)0/2 (0%)
Condition 20/2 (0%)0/2 (0%)0/2 (0%)
Condition 30/2 (0%)0/2 (0%)0/2 (0%)
Condition 40/2 (0%)0/2 (0%)0/2 (0%)
Condition 50/2 (0%)0/2 (0%)0/2 (0%)
Condition 60/2 (0%)0/2 (0%)0/2 (0%)
Condition 70/2 (0%)0/2 (0%)0/2 (0%)
Condition 80/2 (0%)0/2 (0%)0/2 (0%)
Condition 90/2 (0%)0/2 (0%)0/2 (0%)
Condition 100/2 (0%)0/2 (0%)0/2 (0%)
Condition 110/2 (0%)0/2 (0%)0/2 (0%)
Condition 120/2 (0%)0/2 (0%)0/2 (0%)
Condition 130/2 (0%)0/2 (0%)0/2 (0%)
Condition 140/2 (0%)0/2 (0%)0/2 (0%)
Condition 150/2 (0%)0/2 (0%)0/2 (0%)
Condition 160/2 (0%)0/2 (0%)0/2 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Condition 1Condition 2Condition 3Condition 4Condition 5Condition 6Condition 7Condition 8Condition 9Condition 10Condition 11Condition 12Condition 13Condition 14Condition 15Condition 16Total
Mean42.5 ± 9.247.0 ± 18.430.5 ± 0.733.5 ± 6.454.0 ± 17.069.5 ± 0.752.0 ± 18.448.5 ± 0.744.0 ± 11.354.0 ± 18.453.5 ± 14.852.0 ± 11.346.5 ± 27.641.5 ± 17.751.5 ± 0.742.5 ± 2.147.7 ± 13.3
Sex: Female, Male
Sex: Female, Male(Participants)Condition 1Condition 2Condition 3Condition 4Condition 5Condition 6Condition 7Condition 8Condition 9Condition 10Condition 11Condition 12Condition 13Condition 14Condition 15Condition 16Total
Female211221212212122024
Male01100101001010028
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Condition 1Condition 2Condition 3Condition 4Condition 5Condition 6Condition 7Condition 8Condition 9Condition 10Condition 11Condition 12Condition 13Condition 14Condition 15Condition 16Total
American Indian or Alaska Native00000000000000000
Asian10100000000010003
Native Hawaiian or Other Pacific Islander00000000000000000
Black or African American01000001200100005
White011212210221121221
More than one race10001000000000103
Unknown or Not Reported00000000000000000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Condition 1Condition 2Condition 3Condition 4Condition 5Condition 6Condition 7Condition 8Condition 9Condition 10Condition 11Condition 12Condition 13Condition 14Condition 15Condition 16Total
Hispanic or Latino00110010000001105
Not Hispanic or Latino221122122222211227
Unknown or Not Reported00000000000000000
Weight
Weight(lbs.)Condition 1Condition 2Condition 3Condition 4Condition 5Condition 6Condition 7Condition 8Condition 9Condition 10Condition 11Condition 12Condition 13Condition 14Condition 15Condition 16Total
Mean167.5 ± 4.6184.7 ± 22.6182.3 ± 4.2199.2 ± 32.0187.0 ± 16.4204.1 ± 59.5171.9 ± 17.7178.8 ± 28.0162.4 ± 0.6216.1 ± 5.2193.0 ± 31.2192.2 ± 25.2180.2 ± 29.1169.6 ± 0.6201.7 ± 22.6232.5 ± 35.4188.9 ± 26.2
08

Study locations

1 site
  • Stanford University School of Medicine
    Palo Alto, California 94304, United States
09

References and documents

Publications

  • Patel ML, Gallis JA, Zeitlin AB, Crosthwaite PC, Lim AW, Collins KA, Oppezzo MA, Rosas LG. Optimizing Goal Difficulty in a Digital Weight Loss Intervention: The Ignite Pilot Randomized Trial. Obes Sci Pract. 2026 Jul 19;12(4):e70175. doi: 10.1002/osp4.70175. eCollection 2026 Aug. PubMed 42473633 ↗

Study documents

  • Protocol and statistical analysis plan · Jul 10, 2026

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05715242
Lead sponsor
Stanford University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
Michele Patel (Instructor of Medicine, Stanford University) — Principal investigator
First posted
Feb 6, 2023
Start date
Dec 5, 2023
Primary completion
Apr 9, 2024
Completion
Apr 14, 2024
Results posted
May 16, 2025
Last update
Aug 5, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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