ObesityNCT05249465
Spark: Finding the Optimal Tracking Strategy for Weight Loss in a Digital Health Intervention
A study testing Core behavioral weight loss intervention, Self-monitoring diet and Self-monitoring weight in people with Obesity and Overweight, run by Stanford University at 1 site in United States.
Trial summary
This optimization trial will examine three tracking (or "self-monitoring") strategies for weight loss -- tracking dietary intake, steps, and/or body weight -- all delivered through digital health tools. 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, Self-monitoring diet and Self-monitoring weight
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2023to 23 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 a mobile app on their phone
- access to a personal email account
- English language proficiency
- interest in losing weight through behavioral strategies
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
Stanford, California, 94305
About this study
Official title: Optimizing Self-monitoring in a Digital Health Intervention for Weight Loss
This optimization trial will examine three tracking (or "self-monitoring") strategies for weight loss -- tracking dietary intake, steps, and/or body weight -- all delivered through digital health tools. The purpose of the study is to evaluate the combination of these strategies that maximizes 6-month weight loss in the context of a standalone digital health intervention for adults with overweight or obesity.
The investigators will recruit 176 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 6 months, and all participants will receive a "core" treatment consisting of goal setting, behavioral lessons, action plans, and tailored feedback - all of which will be delivered remotely. Depending on which group participants are assigned to in the study, some individuals will be asked to track their dietary intake, their steps, and/or their body weight via digital tools. All study tasks will occur remotely, thus, participants never need to come in-person for any intervention or assessment tasks.
The investigators will use the Multiphase Optimization Strategy (MOST) framework to identify the most effective combination of self-monitoring strategies. The factorial design will allow the research team to determine the unique and combined impact of each self-monitoring component on weight change. The primary outcome is weight change from baseline to 6 months. The research team will also assess self-monitoring engagement over 6 months and its association with weight change. To complement the main trial, the research team will also randomize half of participants to receive an interactive orientation video, in order to assess its impact on trial retention at 6 months. Overall, the information gathered from this trial will enable the construction of an optimized digital health intervention for weight loss that can be delivered remotely, which, if found to be effective, could have high potential for scalability.
- Conditions
- Obesity, Overweight, Weight Loss, Health Behavior
- Being tested
- Core behavioral weight loss intervention, Self-monitoring diet, Self-monitoring weight, Self-monitoring steps
- Keywords
- digital health, mobile health, intervention, weight loss, behavioral treatment, Multiphase Optimization Strategy (MOST), obesity treatment, dietary change, physical activity, self-monitoring, factorial design
- Medical subject headings
- Obesity, Overweight, Weight Loss, Health Behavior, Motor Activity
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 6-month "core" behavioral obesity treatment consisting of goal setting, behavioral lessons, action plans, and tailored feedback - all of which will be delivered remotely.
Self-monitoring dietBehavioural
Participants randomized to receive this component will be instructed to self-monitor their dietary intake daily via the Fitbit mobile app. Participants will receive a daily calorie goal.
Self-monitoring weightBehavioural
Participants randomized to receive this component will be instructed to self-monitor their body weight daily via a wireless e-scale (e.g., the Fitbit Aria Scale).
Self-monitoring stepsBehavioural
Participants randomized to receive this component will be instructed to self-monitor their step count daily via a wrist-worn Fitbit activity monitor. A daily step goal will be given that will adapt based on progress.
| Study group | Role | What they receive |
|---|---|---|
| Condition 1 | Experimental | Core Only Receives: Behavioral: Core behavioral weight loss intervention |
| Condition 2 | Experimental | Core + Track Weight Receives: Behavioral: Core behavioral weight loss intervention; Behavioral: Self-monitoring weight |
| Condition 3 | Experimental | Core + Track Steps Receives: Behavioral: Core behavioral weight loss intervention; Behavioral: Self-monitoring steps |
| Condition 4 | Experimental | Core + Track Diet Receives: Behavioral: Core behavioral weight loss intervention; Behavioral: Self-monitoring diet |
| Condition 5 | Experimental | Core + Track Weight + Track Steps Receives: Behavioral: Core behavioral weight loss intervention; Behavioral: Self-monitoring weight; Behavioral: Self-monitoring steps |
| Condition 6 | Experimental | Core + Track Weight + Track Diet Receives: Behavioral: Core behavioral weight loss intervention; Behavioral: Self-monitoring diet; Behavioral: Self-monitoring weight |
| Condition 7 | Experimental | Core + Track Steps + Track Diet Receives: Behavioral: Core behavioral weight loss intervention; Behavioral: Self-monitoring diet; Behavioral: Self-monitoring steps |
| Condition 8 | Experimental | Core + Track Weight + Track Steps + Track Diet Receives: Behavioral: Core behavioral weight loss intervention; Behavioral: Self-monitoring diet; Behavioral: Self-monitoring weight; Behavioral: Self-monitoring steps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight change from baseline to 6 months
change in weight from baseline to 6-month followup (in kg); assessed objectively via e-scale
Measured: baseline, 6 months
Secondary outcomes (9)
Body weight from baseline to 1 month
change in weight from baseline to 1-month followup (in kg); assessed objectively via e-scale
Measured: baseline, 1 month
Body weight from baseline to 3 months
change in weight from baseline to 3-month followup (in kg); assessed objectively via e-scale
Measured: baseline, 3 month
Clinically significant weight loss
proportion of participants achieving ≥5% weight loss from baseline
Measured: 6 months
BMI change from baseline to 6 months
change in BMI from baseline to 6-month followup (in kg/m^2); computed from self-reported height and e-scale weight
Measured: baseline, 6 months
Caloric intake change from baseline to 6 months
change in caloric intake from baseline to 6-month followup (in kcal); assessed using Automated 24-Hour (ASA-24) Dietary Assessment Tool (2 separate 24hr diet recalls at each time point: 1 week day, 1 weekend day)
Measured: baseline, 6 months
Physical activity change from baseline to 6 months
change in physical activity from baseline to 6-month followup; assessed using Godin Leisure-Time Exercise Questionnaire
Measured: baseline, 6 months
Engagement in self-monitoring dietary intake
average percent of days in the 6-month intervention of self-monitoring dietary intake; assessed objectively via digital health tools (mobile app)
Measured: 6 months of the intervention
Engagement in self-monitoring weight
average percent of days in the 6-month intervention of self-monitoring weight; assessed objectively via digital health tools (e-scale)
Measured: 6 months of the intervention
Engagement in self-monitoring steps
average percent of days in the 6-month intervention of self-monitoring steps; assessed objectively via digital health tools (activity monitor)
Measured: 6 months of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start22 Sep 2023
- Primary completion15 Jun 2025
- Study completion23 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 testing the efficacy of three intervention components, each with two levels (i.e., a 2x2x2).
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Patel, Stanford University
- Investigators
- Michele L Patel, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249465
- Sponsor's protocol ID
- 64716
- Other IDs
- K23DK129805
- Status last verified
- Jun 2025
- First submitted
- 10 Feb 2022
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Once the study data have undergone final data cleaning, analysis, and planned publications, the investigators will make the final data collected as part of the proposed research available in electronic form to researchers who request them. Researchers will be asked to submit a data request in writing to the Principal Investigator so that the requested data can be made available while protecting the confidentiality of study participants and ensuring that the proposed research questions do not overlap with planned publication development by the project research team or other groups. The requested dataset will be free of identifiers that would permit linkages to individual research participants. The requestor must agree to maintain the privacy and confidentiality of the data and must indicate how they plan to store the data to demonstrate compliance with secure computing. All publications that emerge from this award will be publicly available via PubMed Central.
Publications
Patel ML, King AC, Rosas LG, Bennett GG, Collins LM, Gallis JA, Zeitlin AB, Talreja PS, Crosthwaite PC, Collins KA, Lim AW, Kim TS. Optimizing Self-Monitoring in a Digital Weight Loss Intervention (Spark): Protocol for a Factorial Randomized Trial. JMIR Res Protoc. 2025 Sep 23;14:e75629. doi: 10.2196/75629.
PubMed 40986860
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Self-monitoring in a Digital Health Intervention for Weight Loss
- ClinicalTrials.gov ID
- NCT05249465
- Acronym / sponsor ID
- 64716
- Conditions
- Obesity, Overweight, Weight Loss, Health Behavior
- Keywords
- digital health, mobile health, intervention, weight loss, behavioral treatment, Multiphase Optimization Strategy (MOST), obesity treatment, dietary change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 22 Sep 2023 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 23 Jun 2025 (actual)
- First posted
- 21 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This optimization trial will examine three tracking (or "self-monitoring") strategies for weight loss -- tracking dietary intake, steps, and/or body weight -- all delivered through digital health tools. The purpose of the study is to evaluate the combination of these strategies that maximizes 6-month weight loss in the context of a standalone digital health intervention for adults with overweight or obesity.
The investigators will recruit 176 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 6 months, and all participants will receive a "core" treatment consisting of goal setting, behavioral lessons, action plans, and tailored feedback - all of which will be delivered remotely. Depending on which group participants are assigned to in the study, some individuals will be asked to track their dietary intake, their steps, and/or their body weight via digital tools. All study tasks will occur remotely, thus, participants never need to come in-person for any intervention or assessment tasks.
The investigators will use the Multiphase Optimization Strategy (MOST) framework to identify the most effective combination of self-monitoring strategies. The factorial design will allow the research team to determine the unique and combined impact of each self-monitoring component on weight change. The primary outcome is weight change from baseline to 6 months. The research team will also assess self-monitoring engagement over 6 months and its association with weight change. To complement the main trial, the research team will also randomize half of participants to receive an interactive orientation video, in order to assess its impact on trial retention at 6 months. Overall, the information gathered from this trial will enable the construction of an optimized digital health intervention for weight loss that can be delivered remotely, which, if found to be effective, could have high potential for scalability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- This study uses a full factorial experimental design testing the efficacy of three intervention components, each with two levels (i.e., a 2x2x2).
| Arm | Type | Receives |
|---|---|---|
| Condition 1 | Experimental | Behavioral: Core behavioral weight loss interventionCore Only |
| Condition 2 | Experimental | Behavioral: Core behavioral weight loss intervention, Behavioral: Self-monitoring weightCore + Track Weight |
| Condition 3 | Experimental | Behavioral: Core behavioral weight loss intervention, Behavioral: Self-monitoring stepsCore + Track Steps |
| Condition 4 | Experimental | Behavioral: Core behavioral weight loss intervention, Behavioral: Self-monitoring dietCore + Track Diet |
| Condition 5 | Experimental | Behavioral: Core behavioral weight loss intervention, Behavioral: Self-monitoring weight, Behavioral: Self-monitoring stepsCore + Track Weight + Track Steps |
| Condition 6 | Experimental | Behavioral: Core behavioral weight loss intervention, Behavioral: Self-monitoring diet, Behavioral: Self-monitoring weightCore + Track Weight + Track Diet |
| Condition 7 | Experimental | Behavioral: Core behavioral weight loss intervention, Behavioral: Self-monitoring diet, Behavioral: Self-monitoring stepsCore + Track Steps + Track Diet |
| Condition 8 | Experimental | Behavioral: Core behavioral weight loss intervention, Behavioral: Self-monitoring diet, Behavioral: Self-monitoring weight, Behavioral: Self-monitoring stepsCore + Track Weight + Track Steps + Track Diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- adults (ages 18+ years)
- body mass index (BMI) 25.0 to 45.0 kg/m^2
- smartphone ownership
- willingness to install a 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 6-month "core" behavioral obesity treatment consisting of goal setting, behavioral lessons, action plans, and tailored feedback - all of which will be delivered remotely. | Behavioural | Condition 1, Condition 2, Condition 3, Condition 4, Condition 5, Condition 6, Condition 7, Condition 8 |
| Self-monitoring dietParticipants randomized to receive this component will be instructed to self-monitor their dietary intake daily via the Fitbit mobile app. Participants will receive a daily calorie goal. | Behavioural | Condition 4, Condition 6, Condition 7, Condition 8 |
| Self-monitoring weightParticipants randomized to receive this component will be instructed to self-monitor their body weight daily via a wireless e-scale (e.g., the Fitbit Aria Scale). | Behavioural | Condition 2, Condition 5, Condition 6, Condition 8 |
| Self-monitoring stepsParticipants randomized to receive this component will be instructed to self-monitor their step count daily via a wrist-worn Fitbit activity monitor. A daily step goal will be given that will adapt based on progress. | Behavioural | Condition 3, Condition 5, Condition 7, Condition 8 |
Primary outcome
Body weight change from baseline to 6 months
Time frame: baseline, 6 months
change in weight from baseline to 6-month followup (in kg); assessed objectively via e-scale
9 secondary outcomes
Body weight from baseline to 1 month
Time frame: baseline, 1 month
Body weight from baseline to 3 months
Time frame: baseline, 3 month
Clinically significant weight loss
Time frame: 6 months
BMI change from baseline to 6 months
Time frame: baseline, 6 months
Caloric intake change from baseline to 6 months
Time frame: baseline, 6 months
Physical activity change from baseline to 6 months
Time frame: baseline, 6 months
Engagement in self-monitoring dietary intake
Time frame: 6 months of the intervention
Engagement in self-monitoring weight
Time frame: 6 months of the intervention
Engagement in self-monitoring steps
Time frame: 6 months of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Derived from this study: PubMed 40986860Patel ML, King AC, Rosas LG, Bennett GG, Collins LM, Gallis JA, Zeitlin AB, Talreja PS, Crosthwaite PC, Collins KA, Lim AW, Kim TS. Optimizing Self-Monitoring in a Digital Weight Loss Intervention (Spark): Protocol for a Factorial Randomized Trial. JMIR Res Protoc. 2025 Sep 23;14:e75629. doi: 10.2196/75629.
- Individual participant dataSharing planned: No. Once the study data have undergone final data cleaning, analysis, and planned publications, the investigators will make the final data collected as part of the proposed research available in electronic form to researchers who request them. Researchers will be asked to submit a data request in writing to the Principal Investigator so that the requested data can be made available while protecting the confidentiality of study participants and ensuring that the proposed research questions do not overlap with planned publication development by the project research team or other groups. The requested dataset will be free of identifiers that would permit linkages to individual research participants. The requestor must agree to maintain the privacy and confidentiality of the data and must indicate how they plan to store the data to demonstrate compliance with secure computing. All publications that emerge from this award will be publicly available via PubMed Central.
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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.
Michele L Patel, PhD principal investigator
Stanford University
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, Self-monitoring diet and Self-monitoring weight 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 7 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 1 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Body weight change from baseline to 6 months (time frame: baseline, 6 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 NCT05249465, 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 1 Jul 2025.