ObesityNCT05715242
Ignite Pilot: Goal Setting in a Digital Weight Loss Intervention
A study testing Core Behavioral Weight Loss Intervention, Easier Step Goal and Harder Step Goal in people with Obesity and Overweight, run by Stanford University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Overweight, Weight Loss
- What is being tested?
- Core Behavioral Weight Loss Intervention, Easier Step Goal and Harder Step Goal
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2023to 14 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Palo Alto, California, 94304
About this study
Official title: Goal Setting in a Standalone, Digital Weight Loss Intervention: a Pilot Factorial Trial
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.
- Conditions
- Obesity, Overweight, Weight Loss, Health Behavior
- Being tested
- Core Behavioral Weight Loss Intervention, Easier Step Goal, Harder Step Goal, Easier Calorie Goal, Harder Calorie Goal
- Keywords
- weight loss, Multiphase Optimization Strategy, behavioral intervention, factorial trial, goal setting, time-restricted eating
- Medical subject headings
- Obesity, Overweight, Weight Loss, Health Behavior, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core Behavioral Weight Loss InterventionBehavioural
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).
Easier Step GoalBehavioural
Participants will receive an easier daily step goal.
Harder Step GoalBehavioural
Participants will receive a more challenging daily step goal.
Easier Calorie GoalBehavioural
Participants will receive an easier daily calorie goal.
Harder Calorie GoalBehavioural
Participants will receive a more challenging daily calorie goal.
Easier Eating Window GoalBehavioural
Participants will receive an easier daily eating window goal.
Harder Eating Window GoalBehavioural
Participants will receive a more challenging daily eating window goal, akin to time-restricted eating.
Easier Red Zone Food GoalBehavioural
Participants will receive an easier daily Red Zone Food goal.
Harder Red Zone Food GoalBehavioural
Participants will receive a more challenging daily Red Zone Food goal.
| Study group | Role | What they receive |
|---|---|---|
| Condition 1 | Experimental | Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (easier) Receives: 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 |
| Condition 2 | Experimental | Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (harder) Receives: 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 |
| Condition 3 | Experimental | Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (easier) Receives: 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 |
| Condition 4 | Experimental | Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (harder) Receives: 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 |
| Condition 5 | Experimental | Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (easier) Receives: 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 |
| Condition 6 | Experimental | Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (harder) Receives: 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 |
| Condition 7 | Experimental | Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (easier) Receives: 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 |
| Condition 8 | Experimental | Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (harder) Receives: 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 |
| Condition 9 | Experimental | Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (easier) Receives: 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 |
| Condition 10 | Experimental | Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (harder) Receives: 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 |
| Condition 11 | Experimental | Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (easier) Receives: 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 |
| Condition 12 | Experimental | Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (harder) Receives: 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 |
| Condition 13 | Experimental | Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (easier) Receives: 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 |
| Condition 14 | Experimental | Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (harder) Receives: 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 |
| Condition 15 | Experimental | Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (easier) Receives: 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 |
| Condition 16 | Experimental | Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (harder) Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
(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
Measured: baseline to 10 weeks
(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
Measured: baseline to 10 weeks
(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
Measured: baseline to 10 weeks
(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
Measured: 10 weeks
Secondary outcomes (7)
(Feasibility) Retention Rate
the proportion of participants who submitted a weight entry at 10 weeks; a benchmark of 80% would indicate feasibility
Measured: 10 weeks
(Feasibility) Survey Completion Rate
the proportion of participants who completed the web survey; a benchmark of 80% would indicate feasibility
Measured: baseline; 10 weeks
(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
Measured: baseline to 10 weeks
(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
Measured: baseline to 10 weeks
(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
Measured: baseline to 10 weeks
(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
Measured: baseline to 10 weeks
Weight
percentage change in weight from baseline to 10 weeks (end of intervention); assessed objectively via smart scale
Measured: baseline to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start5 Dec 2023
- Primary completion9 Apr 2024
- Study completion14 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Factorial
- Model description
- This study uses a full factorial experimental design to test the impact of four intervention components, each with two levels (i.e., a 2x2x2x2).
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Patel, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715242
- Sponsor's protocol ID
- 68892
- Other IDs
- P30DK116074
- Status last verified
- Jul 2026
- First submitted
- 27 Jan 2023
- Last updated
- 5 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goal Setting in a Standalone, Digital Weight Loss Intervention: a Pilot Factorial Trial
- ClinicalTrials.gov ID
- NCT05715242
- Acronym / sponsor ID
- 68892
- Conditions
- Obesity, Overweight, Weight Loss, Health Behavior
- Keywords
- weight loss, Multiphase Optimization Strategy, behavioral intervention, factorial trial, goal setting, time-restricted eating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- 9 Apr 2024 (actual)
- Study completion
- 14 Apr 2024 (actual)
- First posted
- 6 Feb 2023 (actual)
- Results
- Posted 16 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 16
- Model description
- This study uses a full factorial experimental design to test the impact of four intervention components, each with two levels (i.e., a 2x2x2x2).
| Arm | Type | Receives |
|---|---|---|
| Condition 1 | Experimental | Behavioral: Core Behavioral Weight Loss Intervention, Behavioral: Easier Step Goal, Behavioral: Easier Calorie Goal, Behavioral: Easier Eating Window Goal, Behavioral: Easier Red Zone Food GoalCalorie Goal (easier) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (easier) |
| Condition 2 | Experimental | Behavioral: Core Behavioral Weight Loss Intervention, Behavioral: Easier Step Goal, Behavioral: Easier Calorie Goal, Behavioral: Easier Eating Window Goal, Behavioral: Harder Red Zone Food GoalCalorie Goal (easier) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (harder) |
| Condition 3 | Experimental | Behavioral: Core Behavioral Weight Loss Intervention, Behavioral: Easier Step Goal, Behavioral: Easier Calorie Goal, Behavioral: Harder Eating Window Goal, Behavioral: Easier Red Zone Food GoalCalorie Goal (easier) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (easier) |
| Condition 4 | Experimental | Behavioral: Core Behavioral Weight Loss Intervention, Behavioral: Easier Step Goal, Behavioral: Easier Calorie Goal, Behavioral: Harder Eating Window Goal, Behavioral: Harder Red Zone Food GoalCalorie Goal (easier) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (harder) |
| Condition 5 | Experimental | Behavioral: Core Behavioral Weight Loss Intervention, Behavioral: Harder Step Goal, Behavioral: Easier Calorie Goal, Behavioral: Easier Eating Window Goal, Behavioral: Easier Red Zone Food GoalCalorie Goal (easier) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (easier) |
| Condition 6 | Experimental | Behavioral: Core Behavioral Weight Loss Intervention, Behavioral: Harder Step Goal, Behavioral: Easier Calorie Goal, Behavioral: Easier Eating Window Goal, Behavioral: Harder Red Zone Food GoalCalorie Goal (easier) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (harder) |
| Condition 7 | Experimental | Behavioral: Core Behavioral Weight Loss Intervention, Behavioral: Harder Step Goal, Behavioral: Easier Calorie Goal, Behavioral: Harder Eating Window Goal, Behavioral: Easier Red Zone Food GoalCalorie Goal (easier) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (easier) |
| Condition 8 | Experimental | Behavioral: Core Behavioral Weight Loss Intervention, Behavioral: Harder Step Goal, Behavioral: Easier Calorie Goal, Behavioral: Harder Eating Window Goal, Behavioral: Harder Red Zone Food GoalCalorie Goal (easier) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (harder) |
| Condition 9 | Experimental | Behavioral: Core Behavioral Weight Loss Intervention, Behavioral: Easier Step Goal, Behavioral: Harder Calorie Goal, Behavioral: Easier Eating Window Goal, Behavioral: Easier Red Zone Food GoalCalorie Goal (harder) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (easier) |
| Condition 10 | Experimental | Behavioral: Core Behavioral Weight Loss Intervention, Behavioral: Easier Step Goal, Behavioral: Harder Calorie Goal, Behavioral: Easier Eating Window Goal, Behavioral: Harder Red Zone Food GoalCalorie Goal (harder) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (harder) |
| Condition 11 | Experimental | Behavioral: Core Behavioral Weight Loss Intervention, Behavioral: Easier Step Goal, Behavioral: Harder Calorie Goal, Behavioral: Harder Eating Window Goal, Behavioral: Easier Red Zone Food GoalCalorie Goal (harder) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (easier) |
| Condition 12 | Experimental | Behavioral: Core Behavioral Weight Loss Intervention, Behavioral: Easier Step Goal, Behavioral: Harder Calorie Goal, Behavioral: Harder Eating Window Goal, Behavioral: Harder Red Zone Food GoalCalorie Goal (harder) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (harder) |
| Condition 13 | Experimental | Behavioral: Core Behavioral Weight Loss Intervention, Behavioral: Harder Step Goal, Behavioral: Harder Calorie Goal, Behavioral: Easier Eating Window Goal, Behavioral: Easier Red Zone Food GoalCalorie Goal (harder) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (easier) |
| Condition 14 | Experimental | Behavioral: Core Behavioral Weight Loss Intervention, Behavioral: Harder Step Goal, Behavioral: Harder Calorie Goal, Behavioral: Easier Eating Window Goal, Behavioral: Harder Red Zone Food GoalCalorie Goal (harder) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (harder) |
| Condition 15 | Experimental | Behavioral: Core Behavioral Weight Loss Intervention, Behavioral: Harder Step Goal, Behavioral: Harder Calorie Goal, Behavioral: Harder Eating Window Goal, Behavioral: Easier Red Zone Food GoalCalorie Goal (harder) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (easier) |
| Condition 16 | Experimental | Behavioral: Core Behavioral Weight Loss Intervention, Behavioral: Harder Step Goal, Behavioral: Harder Calorie Goal, Behavioral: Harder Eating Window Goal, Behavioral: Harder Red Zone Food GoalCalorie Goal (harder) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (harder) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core Behavioral Weight Loss InterventionAll 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). | Behavioural | Condition 1, Condition 10, Condition 11, Condition 12, Condition 13, Condition 14, Condition 15, Condition 16, Condition 2, Condition 3, Condition 4, Condition 5, Condition 6, Condition 7, Condition 8, Condition 9 |
| Easier Step GoalParticipants will receive an easier daily step goal. | Behavioural | Condition 1, Condition 10, Condition 11, Condition 12, Condition 2, Condition 3, Condition 4, Condition 9 |
| Harder Step GoalParticipants will receive a more challenging daily step goal. | Behavioural | Condition 13, Condition 14, Condition 15, Condition 16, Condition 5, Condition 6, Condition 7, Condition 8 |
| Easier Calorie GoalParticipants will receive an easier daily calorie goal. | Behavioural | Condition 1, Condition 2, Condition 3, Condition 4, Condition 5, Condition 6, Condition 7, Condition 8 |
| Harder Calorie GoalParticipants will receive a more challenging daily calorie goal. | Behavioural | Condition 10, Condition 11, Condition 12, Condition 13, Condition 14, Condition 15, Condition 16, Condition 9 |
| Easier Eating Window GoalParticipants will receive an easier daily eating window goal. | Behavioural | Condition 1, Condition 10, Condition 13, Condition 14, Condition 2, Condition 5, Condition 6, Condition 9 |
| Harder Eating Window GoalParticipants will receive a more challenging daily eating window goal, akin to time-restricted eating. | Behavioural | Condition 11, Condition 12, Condition 15, Condition 16, Condition 3, Condition 4, Condition 7, Condition 8 |
| Easier Red Zone Food GoalParticipants will receive an easier daily Red Zone Food goal. | Behavioural | Condition 1, Condition 11, Condition 13, Condition 15, Condition 3, Condition 5, Condition 7, Condition 9 |
| Harder Red Zone Food GoalParticipants will receive a more challenging daily Red Zone Food goal. | Behavioural | Condition 10, Condition 12, Condition 14, Condition 16, Condition 2, Condition 4, Condition 6, Condition 8 |
Primary outcome
(Feasibility) Engagement in Self-monitoring Body Weight
Time frame: baseline to 10 weeks
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
(Feasibility) Engagement in Self-monitoring Steps
Time frame: baseline to 10 weeks
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
(Feasibility) Engagement in Self-monitoring Dietary Intake
Time frame: baseline to 10 weeks
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
(Acceptability) Would You Recommend the Weight Loss Program to a Friend Who is Trying to Lose Weight?
Time frame: 10 weeks
1-item measure; a benchmark of 80% of participants answering "yes" would indicate acceptability
7 secondary outcomes
(Feasibility) Retention Rate
Time frame: 10 weeks
(Feasibility) Survey Completion Rate
Time frame: baseline; 10 weeks
(Feasibility) Goal Attainment of Calorie Goal
Time frame: baseline to 10 weeks
(Feasibility) Goal Attainment of Step Goal
Time frame: baseline to 10 weeks
(Feasibility) Goal Attainment of Eating Window Goal
Time frame: baseline to 10 weeks
(Feasibility) Goal Attainment of Red Zone Food Goal
Time frame: baseline to 10 weeks
Weight
Time frame: baseline to 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42473633Patel 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.
- Individual participant dataSharing planned: No
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HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
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ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease
Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core Behavioral Weight Loss Intervention, Easier Step Goal and Harder Step Goal in people with Obesity and Overweight, 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 8 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: finished, as of the sponsor's last update on 5 Aug 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?
Yes. Results are posted in the registry (first posted 16 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(Feasibility) Engagement in Self-monitoring Body Weight (time frame: baseline to 10 weeks). The study lists 4 primary outcomes in all. 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 NCT05715242, which also lists 1 linked publication.
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 5 Aug 2026.