Spark: Znalezienie optymalnej strategii śledzenia utraty wagi w cyfrowej interwencji zdrowotnej
Optymalizacja samokontroli w cyfrowej interwencji zdrowotnej w celu utraty wagi
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.
Przegląd badań
Status
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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California
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Stanford, California, Stany Zjednoczone, 94305
- Stanford University School of Medicine
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przypisanie czynnikowe
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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. |
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Eksperymentalny: 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). |
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Eksperymentalny: 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. |
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Eksperymentalny: 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. |
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Eksperymentalny: 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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Eksperymentalny: 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. |
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Eksperymentalny: 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. |
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Eksperymentalny: 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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Body Weight Change From Baseline to 6 Months
Ramy czasowe: baseline, 6 months
|
change in weight from baseline to 6-month followup (in kg); assessed objectively via e-scale |
baseline, 6 months
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Body Weight From Baseline to 1 Month
Ramy czasowe: baseline, 1 month
|
change in weight from baseline to 1-month followup (in kg); assessed objectively via e-scale |
baseline, 1 month
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Body Weight From Baseline to 3 Months
Ramy czasowe: baseline, 3 month
|
change in weight from baseline to 3-month followup (in kg); assessed objectively via e-scale |
baseline, 3 month
|
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Clinically Significant Weight Loss
Ramy czasowe: 6 months
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proportion of participants achieving ≥5% weight loss from baseline |
6 months
|
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BMI Change From Baseline to 6 Months
Ramy czasowe: baseline, 6 months
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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
|
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Caloric Intake Change From Baseline to 6 Months
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 6 months of the intervention
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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
|
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Engagement in Self-monitoring Steps
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Michele L Patel, PhD, Stanford University
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 64716
- K23DK129805 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
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.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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