Goal Setting in a Standalone, Digital Weight Loss Intervention: a Pilot Factorial Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- (Feasibility) Engagement in Self-monitoring Body Weight
研究概览
简要总结
The goal of this pilot trial is to learn about the optimal intensity level of goals in a digital weight loss intervention among adults with overweight or obesity. The main questions of the study are to assess the feasibility and acceptability of different goal intensities across four domains (calorie goal, step goal, eating window goal, red zone food goal).
The investigators will recruit 32 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 10 weeks, and all participants will receive a "core" treatment consisting of self-monitoring weight, food intake, and steps (all via digital tools provided by the study team), along with behavioral lessons, action plans, and tailored feedback. Depending on which group participants are assigned to in the study, individuals will receive either a more or less challenging goal across the four domains. All study tasks will occur remotely, thus, participants will never come in-person for any tasks. Assessment of body weight and other measures will occur at the beginning of the trial ("baseline"), and at 4 weeks and 10 weeks.
The investigators will use the Multiphase Optimization Strategy (MOST) framework to identify which of the goal intensity levels result in meaningful engagement and weight loss. The current study is the first step towards answering this question; it is designed as a pilot factorial trial, which focuses on feasibility and acceptability. In total, there will be 16 treatment conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults (ages 18+ years)
- •body mass index (BMI) 25.0 to 45.0 kg/m^2
- •smartphone ownership
- •willingness to install the Fitbit mobile app on their phone
- •access to a personal email account
- •English language proficiency
- •interest in losing weight through behavioral strategies
- •living in the United States
排除标准
- •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
研究组 & 干预措施
Condition 1
Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (easier)
干预措施: Easier Calorie Goal (Behavioral)
Condition 1
Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (easier)
干预措施: Easier Eating Window Goal (Behavioral)
Condition 2
Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (harder)
干预措施: Easier Calorie Goal (Behavioral)
Condition 2
Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (harder)
干预措施: Easier Eating Window Goal (Behavioral)
Condition 2
Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (harder)
干预措施: Harder Red Zone Food Goal (Behavioral)
Condition 3
Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (easier)
干预措施: Core Behavioral Weight Loss Intervention (Behavioral)
Condition 3
Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (easier)
干预措施: Easier Step Goal (Behavioral)
Condition 3
Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (easier)
干预措施: Easier Calorie Goal (Behavioral)
Condition 3
Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (easier)
干预措施: Harder Eating Window Goal (Behavioral)
Condition 3
Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (easier)
干预措施: Easier Red Zone Food Goal (Behavioral)
Condition 4
Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (harder)
干预措施: Core Behavioral Weight Loss Intervention (Behavioral)
Condition 4
Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (harder)
干预措施: Easier Step Goal (Behavioral)
Condition 4
Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (harder)
干预措施: Easier Calorie Goal (Behavioral)
Condition 4
Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (harder)
干预措施: Harder Red Zone Food Goal (Behavioral)
Condition 5
Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (easier)
干预措施: Harder Step Goal (Behavioral)
Condition 5
Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (easier)
干预措施: Easier Calorie Goal (Behavioral)
Condition 5
Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (easier)
干预措施: Easier Eating Window Goal (Behavioral)
Condition 5
Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (easier)
干预措施: Easier Red Zone Food Goal (Behavioral)
Condition 5
Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (easier)
干预措施: Core Behavioral Weight Loss Intervention (Behavioral)
Condition 6
Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (harder)
干预措施: Core Behavioral Weight Loss Intervention (Behavioral)
Condition 6
Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (harder)
干预措施: Harder Step Goal (Behavioral)
Condition 6
Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (harder)
干预措施: Easier Calorie Goal (Behavioral)
Condition 6
Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (harder)
干预措施: Easier Eating Window Goal (Behavioral)
Condition 6
Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (harder)
干预措施: Harder Red Zone Food Goal (Behavioral)
Condition 7
Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (easier)
干预措施: Core Behavioral Weight Loss Intervention (Behavioral)
Condition 7
Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (easier)
干预措施: Harder Step Goal (Behavioral)
Condition 8
Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (harder)
干预措施: Harder Step Goal (Behavioral)
Condition 8
Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (harder)
干预措施: Easier Calorie Goal (Behavioral)
Condition 8
Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (harder)
干预措施: Harder Eating Window Goal (Behavioral)
Condition 8
Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (harder)
干预措施: Harder Red Zone Food Goal (Behavioral)
Condition 9
Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (easier)
干预措施: Core Behavioral Weight Loss Intervention (Behavioral)
Condition 9
Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (easier)
干预措施: Easier Step Goal (Behavioral)
Condition 9
Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (easier)
干预措施: Harder Calorie Goal (Behavioral)
Condition 9
Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (easier)
干预措施: Easier Eating Window Goal (Behavioral)
Condition 9
Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (easier)
干预措施: Easier Red Zone Food Goal (Behavioral)
Condition 10
Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (harder)
干预措施: Core Behavioral Weight Loss Intervention (Behavioral)
Condition 10
Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (harder)
干预措施: Harder Calorie Goal (Behavioral)
Condition 10
Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (harder)
干预措施: Easier Eating Window Goal (Behavioral)
Condition 10
Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (harder)
干预措施: Harder Red Zone Food Goal (Behavioral)
Condition 11
Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (easier)
干预措施: Core Behavioral Weight Loss Intervention (Behavioral)
Condition 11
Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (easier)
干预措施: Easier Step Goal (Behavioral)
Condition 11
Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (easier)
干预措施: Harder Calorie Goal (Behavioral)
Condition 11
Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (easier)
干预措施: Harder Eating Window Goal (Behavioral)
Condition 11
Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (easier)
干预措施: Easier Red Zone Food Goal (Behavioral)
Condition 12
Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (harder)
干预措施: Core Behavioral Weight Loss Intervention (Behavioral)
Condition 12
Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (harder)
干预措施: Easier Step Goal (Behavioral)
Condition 12
Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (harder)
干预措施: Harder Calorie Goal (Behavioral)
Condition 12
Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (harder)
干预措施: Harder Eating Window Goal (Behavioral)
Condition 12
Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (harder)
干预措施: Harder Red Zone Food Goal (Behavioral)
Condition 14
Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (harder)
干预措施: Harder Step Goal (Behavioral)
Condition 14
Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (harder)
干预措施: Harder Calorie Goal (Behavioral)
Condition 14
Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (harder)
干预措施: Easier Eating Window Goal (Behavioral)
Condition 14
Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (harder)
干预措施: Harder Red Zone Food Goal (Behavioral)
Condition 15
Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (easier)
干预措施: Core Behavioral Weight Loss Intervention (Behavioral)
Condition 15
Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (easier)
干预措施: Harder Step Goal (Behavioral)
Condition 15
Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (easier)
干预措施: Harder Calorie Goal (Behavioral)
Condition 15
Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (easier)
干预措施: Harder Eating Window Goal (Behavioral)
Condition 15
Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (easier)
干预措施: Easier Red Zone Food Goal (Behavioral)
Condition 16
Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (harder)
干预措施: Core Behavioral Weight Loss Intervention (Behavioral)
Condition 16
Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (harder)
干预措施: Harder Step Goal (Behavioral)
Condition 1
Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (easier)
干预措施: Core Behavioral Weight Loss Intervention (Behavioral)
Condition 1
Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (easier)
干预措施: Easier Step Goal (Behavioral)
Condition 1
Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (easier)
干预措施: Easier Red Zone Food Goal (Behavioral)
Condition 2
Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (harder)
干预措施: Core Behavioral Weight Loss Intervention (Behavioral)
Condition 2
Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (harder)
干预措施: Easier Step Goal (Behavioral)
Condition 4
Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (harder)
干预措施: Harder Eating Window Goal (Behavioral)
Condition 7
Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (easier)
干预措施: Easier Calorie Goal (Behavioral)
Condition 7
Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (easier)
干预措施: Harder Eating Window Goal (Behavioral)
Condition 7
Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (easier)
干预措施: Easier Red Zone Food Goal (Behavioral)
Condition 8
Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (harder)
干预措施: Core Behavioral Weight Loss Intervention (Behavioral)
Condition 10
Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (harder)
干预措施: Easier Step Goal (Behavioral)
Condition 13
Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (easier)
干预措施: Core Behavioral Weight Loss Intervention (Behavioral)
Condition 13
Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (easier)
干预措施: Harder Step Goal (Behavioral)
Condition 13
Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (easier)
干预措施: Harder Calorie Goal (Behavioral)
Condition 13
Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (easier)
干预措施: Easier Eating Window Goal (Behavioral)
Condition 13
Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (easier)
干预措施: Easier Red Zone Food Goal (Behavioral)
Condition 14
Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (harder)
干预措施: Core Behavioral Weight Loss Intervention (Behavioral)
Condition 16
Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (harder)
干预措施: Harder Calorie Goal (Behavioral)
Condition 16
Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (harder)
干预措施: Harder Eating Window Goal (Behavioral)
Condition 16
Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (harder)
干预措施: Harder Red Zone Food Goal (Behavioral)
结局指标
主要结局
(Feasibility) Engagement in Self-monitoring Body Weight
时间窗: baseline to 10 weeks
average percentage of days in the 10-week intervention of self-monitoring weight (assessed objectively via smart scale); a benchmark of self-monitoring 75% of days would indicate feasibility
(Feasibility) Engagement in Self-monitoring Steps
时间窗: baseline to 10 weeks
average percentage of days in the 10-week intervention of self-monitoring steps (assessed objectively via Fitbit activity tracker); a benchmark of self-monitoring 75% of days would indicate feasibility
(Feasibility) Engagement in Self-monitoring Dietary Intake
时间窗: baseline to 10 weeks
average percentage of days in the 10-week intervention of self-monitoring dietary intake (assessed via Fitbit mobile app); a benchmark of self-monitoring 75% of days would indicate feasibility
(Acceptability) Would You Recommend the Weight Loss Program to a Friend Who is Trying to Lose Weight?
时间窗: 10 weeks
1-item measure; a benchmark of 80% of participants answering "yes" would indicate acceptability
次要结局
- (Feasibility) Retention Rate(10 weeks)
- (Feasibility) Survey Completion Rate(baseline; 10 weeks)
- (Feasibility) Goal Attainment of Calorie Goal(baseline to 10 weeks)
- (Feasibility) Goal Attainment of Step Goal(baseline to 10 weeks)
- (Feasibility) Goal Attainment of Eating Window Goal(baseline to 10 weeks)
- (Feasibility) Goal Attainment of Red Zone Food Goal(baseline to 10 weeks)
- Weight(baseline to 10 weeks)
研究者
Michele Patel
Instructor of Medicine
Stanford University