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| ID | Type | Description | Link |
|---|---|---|---|
| K23DK129805 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Condition 1 | Experimental | Core Only |
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| Condition 2 | Experimental | Core + Track Weight |
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| Condition 3 | Experimental | Core + Track Steps |
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| Condition 4 | Experimental | Core + Track Diet |
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| Condition 5 | Experimental | Core + Track Weight + Track Steps |
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| Condition 6 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Core behavioral weight loss intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight change from baseline to 6 months | change in weight from baseline to 6-month followup (in kg); assessed objectively via e-scale | baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight from baseline to 1 month | change in weight from baseline to 1-month followup (in kg); assessed objectively via e-scale | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michele L Patel, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40986860 | Derived | 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. |
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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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 24, 2025 | Jun 28, 2025 |
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This study uses a full factorial experimental design testing the efficacy of three intervention components, each with two levels (i.e., a 2x2x2).
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Outcomes will be analyzed in a blinded fashion such that treatment allocation is not revealed.
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Core + Track Weight + Track Diet |
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| Condition 7 | Experimental | Core + Track Steps + Track Diet |
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| Condition 8 | Experimental | Core + Track Weight + Track Steps + Track Diet |
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| Self-monitoring diet | Behavioral | 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. |
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| Self-monitoring weight | Behavioral | 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). |
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| Self-monitoring steps | Behavioral | 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. |
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| baseline, 3 month |
| Clinically significant weight loss | proportion of participants achieving ≥5% weight loss from baseline | 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 | 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) | 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 | 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) | 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) | 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) | 6 months of the intervention |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 2, 2024 | Jun 28, 2025 | ICF_001.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 15, 2026 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D015431 | Weight Loss |
| D015438 | Health Behavior |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D001519 | Behavior |
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