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The purpose of this study is to compare two approaches for tracking dietary intake in a 12-month fully digital weight loss intervention: (1) Simplified approach: track Red Zone Foods (e.g., foods high in calories and low in nutritional value) vs. (2) Detailed approach: track all foods and their corresponding calories. In essence, this is a head-to-head comparison of two tracking approaches; the investigators are evaluating whether weight loss is comparable over 12 months, or whether one approach will have greater weight loss.
The investigators will recruit 328 adults. Broadly, adults with overweight or obesity who live in the United States will be eligible. The weight loss intervention will last 12 months. All participants will be asked to track their dietary intake + body weight + steps daily as well as complete weekly behavioral lessons and action plans to promote healthy eating and physical activity. All study tasks will occur remotely. Assessment of body weight and survey measures will occur at the beginning of the trial ("baseline"), and at 1, 6, 12, and 18 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simplified (Track Red Zone Foods) | Experimental | Simplified + Core |
|
| Detailed (Track All Foods/Calories) | Experimental | Detailed + Core |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simplified Dietary Self-Monitoring | Behavioral | Participants randomized to receive this intervention are instructed to track their Red Zone Foods (i.e., foods high in calories and low in nutritional value) daily via a web-based checklist. Participants receive a daily Red Zone Food goal. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Change from Baseline to 12 Months | mean change in body weight (kg); assessed objectively via e-scale using standardized procedures (e.g., place the scale on a hard surface; collect weight in the morning, without clothing, prior to eating/drinking) | Baseline, 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Change from Baseline to 1 Month | mean change in body weight (kg); assessed objectively via e-scale using standardized procedures | Baseline, 1 Month |
| Weight Change from Baseline to 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Team | Contact | 650-549-7047 | mlp9@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michele L. Patel, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Palo Alto | California | 94304 | United States |
The de-identified dataset and metadata will be made available through a public repository. It will include the primary outcome (weight change), secondary outcomes, and participant level characteristics. Data will be available in an Excel spreadsheet, whereby each row corresponds to a unique participant's data, and columns represent the different variables mentioned, by time point.
The shared dataset and metadata will be preserved and made publicly available to share for at least 3 years following completion of the project, in accordance with NIH regulations. They will be made available upon publication of the primary outcomes paper in a peer-reviewed journal, or at the end of the grant period (whichever comes first).
Publicly available.
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D015431 | Weight Loss |
| D015438 | Health Behavior |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D012816 | Signs and Symptoms |
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This study is a two-arm, noninferiority trial that randomizes participants to either the Simplified or Detailed arm using a 1:1 allocation. The trial is powered to evaluate noninferiority between these two self-monitoring approaches for the primary outcome of 12-month weight change. Noninferiority is met if the upper limit of the confidence interval for the between-arm difference in weight change is below a 2.5 kg margin. If noninferiority is met, we will test for superiority.
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| Detailed Dietary Self-Monitoring | Behavioral | Participants randomized to receive this intervention are instructed to track all foods/drinks and their corresponding calories daily via a mobile app. Participants receive a daily calorie goal. |
|
| Core Behavioral Weight Loss Intervention | Behavioral | All participants receive a 12-month core behavioral weight loss intervention consisting of the following: goal setting; daily self-monitoring of body weight & steps; weekly behavioral lessons and action plans to promote healthy eating and physical activity; and tailored feedback. The intervention will be delivered remotely via email and/or text message. |
|
mean change in body weight (kg); assessed objectively via e-scale using standardized procedures
| Baseline, 6 Months |
| Weight Change from Baseline to 18 Months | mean change in body weight (kg); assessed objectively via e-scale using standardized procedures | Baseline, 18 Months |
| Caloric Intake Change from Baseline to 12 Months | mean change in daily caloric intake (kilocalories); assessed via the Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24): 2 separate diet recalls per time point: 1 week day, 1 weekend day | Baseline, 12 Months |
| Diet Quality Change from Baseline to 12 Months | mean change in diet quality; assessed via the Healthy Eating Index, calculated from ASA24 data; score range: 0 to 100, with higher scores indicating better diet quality | Baseline, 12 Months |
| Step Count Change from Baseline to 12 Months | mean change in step count; assessed objectively via activity tracker | Baseline, 12 Months |
| Health-Related Quality of Life (Physical Health) Change from Baseline to 12 Months | mean change in health-related quality of life (Physical Component Summary); assessed via the SF-36 survey; score range: 0 to 100, with higher scores indicating better quality of life | Baseline, 12 Months |
| Health-Related Quality of Life (Mental Health) Change from Baseline to 12 Months | mean change in health-related quality of life (Mental Component Summary); assessed via the SF-36 survey; score range: 0 to 100, with higher scores indicating better quality of life | Baseline, 12 Months |
| Engagement in Self-Monitoring Dietary Intake | operationalized as average percentage of days in the 12-month intervention of self-monitoring dietary intake (Red Zone Foods for Simplified arm vs. all foods/calories for Detailed arm); assessed via e-checklist for Simplified arm and via app for Detailed arm; will report median (IQR) if data are non-normally distributed | daily during the 12-month intervention |
| Engagement in Self-Monitoring Weight | operationalized as average percentage of days in the 12-month intervention of self-monitoring body weight; assessed via e-scale; will report median (IQR) if data are non-normally distributed | daily during the 12-month intervention |
| Engagement in Self-Monitoring Steps | operationalized as average percentage of days in the 12-month intervention of self-monitoring steps; assessed via activity tracker; will report median (IQR) if data are non-normally distributed | daily during the 12-month intervention |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D001519 | Behavior |