Spark: Find den optimale sporingsstrategi for vægttab i en digital sundhedsintervention
Optimering af selvovervågning i en digital sundhedsintervention til vægttab
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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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California
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Stanford, California, Forenede Stater, 94305
- Stanford University School of Medicine
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 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
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Condition 1
Core Only |
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. |
|
Eksperimentel: Condition 2
Core + Track Weight |
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. 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). |
|
Eksperimentel: Condition 3
Core + Track Steps |
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. 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. |
|
Eksperimentel: Condition 4
Core + Track Diet |
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. 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. |
|
Eksperimentel: Condition 5
Core + Track Weight + Track Steps |
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. 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). 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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Eksperimentel: Condition 6
Core + Track Weight + Track Diet |
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. 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). 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. |
|
Eksperimentel: Condition 7
Core + Track Steps + Track Diet |
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. 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. 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. |
|
Eksperimentel: Condition 8
Core + Track Weight + Track Steps + Track Diet |
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. 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). 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. 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Body Weight Change From Baseline to 6 Months
Tidsramme: baseline, 6 months
|
change in weight from baseline to 6-month followup (in kg); assessed objectively via e-scale |
baseline, 6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Body Weight From Baseline to 1 Month
Tidsramme: baseline, 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
Tidsramme: baseline, 3 month
|
change in weight from baseline to 3-month followup (in kg); assessed objectively via e-scale |
baseline, 3 month
|
|
Clinically Significant Weight Loss
Tidsramme: 6 months
|
proportion of participants achieving ≥5% weight loss from baseline |
6 months
|
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BMI Change From Baseline to 6 Months
Tidsramme: baseline, 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
Tidsramme: baseline, 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
|
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Physical Activity Change From Baseline to 6 Months
Tidsramme: baseline, 6 months
|
change in physical activity from baseline to 6-month followup; assessed using Godin Leisure-Time Exercise Questionnaire (GLTEQ)'s MVPA Score Index. The GLTEQ is a self-report measure that assesses a typical week's frequency of engaging in different types of exercise for at least 15 minutes. Minimum score is 0; there is no maximum score. Higher scores indicate more frequent moderate-to-vigorous physical activity. Scores ≥ 24 indicate "active" while scores < 24 indicate "insufficiently active." |
baseline, 6 months
|
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Engagement in Self-monitoring Dietary Intake
Tidsramme: 6 months of the intervention
|
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
|
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Engagement in Self-monitoring Weight
Tidsramme: 6 months of the intervention
|
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
Tidsramme: 6 months of the intervention
|
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
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Michele L Patel, PhD, Stanford University
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 64716
- K23DK129805 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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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