Simplifying Diet Tracking in a Digital Weight Loss Intervention

Официальное название

Simplifying Dietary Self-Monitoring in a Digital Weight Loss Intervention

Обзор

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.

Вмешательства

• Поведенческое Simplified Dietary Self-Monitoring
  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.
• Поведенческое Detailed Dietary Self-Monitoring
  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.
• Поведенческое Core Behavioral Weight Loss Intervention
  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.

Первичные конечные точки

• Weight Change from Baseline to 12 Months [Срок оценки: Baseline, 12 Months]

Вторичные конечные точки (11)

• Weight Change from Baseline to 1 Month [Срок оценки: Baseline, 1 Month]
• Weight Change from Baseline to 6 Months [Срок оценки: Baseline, 6 Months]
• Weight Change from Baseline to 18 Months [Срок оценки: Baseline, 18 Months]
• Caloric Intake Change from Baseline to 12 Months [Срок оценки: Baseline, 12 Months]
• Diet Quality Change from Baseline to 12 Months [Срок оценки: Baseline, 12 Months]
• Step Count Change from Baseline to 12 Months [Срок оценки: Baseline, 12 Months]
• Health-Related Quality of Life (Physical Health) Change from Baseline to 12 Months [Срок оценки: Baseline, 12 Months]
• Health-Related Quality of Life (Mental Health) Change from Baseline to 12 Months [Срок оценки: Baseline, 12 Months]
• Engagement in Self-Monitoring Dietary Intake [Срок оценки: daily during the 12-month intervention]
• Engagement in Self-Monitoring Weight [Срок оценки: daily during the 12-month intervention]
• Engagement in Self-Monitoring Steps [Срок оценки: daily during the 12-month intervention]

Критерии участия

Критерии включения

• adults (ages 18+ years)
• body mass index (BMI) 25.0 to 45.0 kg/m\^2
• smartphone ownership
• willing to install a mobile app on personal smartphone
• access to a personal email account
• English or Spanish language proficiency
• interest in losing weight through behavioral strategies
• living in the United States
• willing to be randomized

Критерии исключения

• concurrent enrollment in another weight management intervention
• loss of ≥5% weight in the past 6 months
• prior or planned bariatric surgery during the trial period
• current or planned pregnancy during the trial period, or recent pregnancy in the past 6 months
• currently breastfeeding or lactating
• current use of anti-obesity medications
• living 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
• medical or psychiatric contraindication (e.g., end stage renal disease, cancer, schizophrenia, dementia, use of steroids, use of antipsychotic medication)
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Stanford University School of Medicine — Palo Alto

Идентификаторы

NCT: NCT07601061 · 87051

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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