PATH to Health: An Exploration of Digital Behavioral Weight Loss Approaches
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Feasibility- Rate of early nonresponse
研究概览
简要总结
The purpose of this initial pilot and feasibility study is to test different digital, behavioral weight loss approaches, with or without human support, using a sequential, multiple assignment, randomized trial (SMART) design. All participants in this pilot trial will receive a 3-month mobile health (mHealth) program. The dose of human support will vary by first- and second-line randomizations. The feasibility, acceptability, and preliminary outcomes for each of the treatment sequences will be assessed.
详细描述
Ninety-nine adults, ages 18-65, with overweight or obesity, will be randomized in total. All participants will receive an mHealth program (App) for program duration that includes activity tracking with a Fitbit, weight tracking with a smart scale, and an app for diet tracking. At baseline, participants will be randomized to either a a) Fully Automated Kick-Off, or b) Human-Enhanced Kick-Off. "Early responders" will continue with to use App, alone. After 4 weeks, "early non-responders" in both arms will be re-randomized once to one of two augmented interventions with human support: Counseling or Check-In. Assessments will occur at baseline, 1 week, 4 weeks, and 3 months to explore feasibility, acceptability, and preliminary outcomes (weight, self-monitoring adherence, behavioral goal adherence).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current age: 18-65 years
- •Lives in North Carolina
- •Body mass index (BMI) of 27.5-45 kg/m^2
- •Ability to read, write, and speak English
- •Ownership of iPhone with a data and texting plan
- •Ability to commit to the required counseling sessions (0-5 sessions, based on randomization)
- •Is not living a participant or staff member on this trial
- •Willingness to be randomized to any of the treatment sequences
排除标准
- •Weight loss of more than 10 pounds in the last 6 months that was maintained
- •A history of weight loss surgery
- •Pre-existing medical condition(s) that prevent them from adhering to a supervised exercise routine
- •Have Type 1 Diabetes or are currently taking medicine for Type 2 Diabetes
- •Have recently been diagnosed or treated for cancer
- •Currently pregnant, pregnant within the past 6 months, or plan to become pregnant in the next 6 months
- •Report taking prescription or over the counter medication with a known impact on metabolism or weight
- •Report a history of an eating disorder
- •History of psychotic disorder or bipolar disorder, or have been hospitalized for depression or other psychiatric disorder within the past 12 months
- •History of alcohol or substance abuse
- •Current participation in another weight loss program that may interfere with participation in this study
研究组 & 干预措施
Fully Automated Kick-Off + App
This arm includes participants who respond to the Fully Automated Kick-Off + App in stage 1.
In stage 1, participants will receive a Fully Automated Kick-Off and an mHealth program.
In stage 2, responders to the Fully Automated Kick-Off + App will continue with the mHealth program, alone, for the remainder of the study.
干预措施: Fully Automated Kick-Off (Behavioral)
Human-Enhanced Kick-Off + App
This arm includes participants who respond to the Human-Enhanced Kick-Off + App in stage 1.
In stage 1, the participant's kick-off will include a session with a study interventionist. They will also receive an mHealth program.
In stage 2, responders to the Human-Enhanced Kick-Off + App will continue with the mHealth program, alone, for the remainder of the study.
干预措施: Human-Enhanced Kick-Off (Behavioral)
Fully Automated Kick-Off + App + Check-In
This arm includes participants who do not respond to the Fully Automated Kick-Off + App in stage 1.
In stage 1, participants will receive a Fully Automated Kick-Off and an mHealth program.
In stage 2, they will continue with the mHealth program, but will also receive a check-in with a study interventionist.
干预措施: Fully Automated Kick-Off (Behavioral)
Fully Automated Kick-Off + App + Check-In
This arm includes participants who do not respond to the Fully Automated Kick-Off + App in stage 1.
In stage 1, participants will receive a Fully Automated Kick-Off and an mHealth program.
In stage 2, they will continue with the mHealth program, but will also receive a check-in with a study interventionist.
干预措施: Check-In (Behavioral)
Fully Automated Kick-Off + App + Counseling
This arm includes participants who do not respond to the Fully Automated Kick-Off + App in stage 1.
In stage 1, participants will receive a Fully Automated Kick-Off and an mHealth program.
In stage 2, they will continue with the standard mHealth program, but will also receive counseling from a study interventionist.
干预措施: Fully Automated Kick-Off (Behavioral)
Fully Automated Kick-Off + App + Counseling
This arm includes participants who do not respond to the Fully Automated Kick-Off + App in stage 1.
In stage 1, participants will receive a Fully Automated Kick-Off and an mHealth program.
In stage 2, they will continue with the standard mHealth program, but will also receive counseling from a study interventionist.
干预措施: Counseling (Behavioral)
Human-Enhanced Kick-Off + App + Check-In
This arm includes participants who do not respond to the Human-Enhanced Kick-Off + App in stage 1.
In stage 1, the participant's kick-off will include a session with a study interventionist. They will also receive an mHealth program.
In stage 2, they will continue with the mHealth program, but will also receive a check-in with a study interventionist.
干预措施: Human-Enhanced Kick-Off (Behavioral)
Human-Enhanced Kick-Off + App + Check-In
This arm includes participants who do not respond to the Human-Enhanced Kick-Off + App in stage 1.
In stage 1, the participant's kick-off will include a session with a study interventionist. They will also receive an mHealth program.
In stage 2, they will continue with the mHealth program, but will also receive a check-in with a study interventionist.
干预措施: Check-In (Behavioral)
Human-Enhanced Kick-Off + App + Counseling
This arm includes participants who do not respond to the Human-Enhanced Kick-Off + App in stage 1.
In stage 1, the participant's kick-off will include a session with a study interventionist. They will also receive an mHealth program.
In stage 2, they will continue with the standard mHealth program, but will also receive counseling from a study interventionist.
干预措施: Human-Enhanced Kick-Off (Behavioral)
Human-Enhanced Kick-Off + App + Counseling
This arm includes participants who do not respond to the Human-Enhanced Kick-Off + App in stage 1.
In stage 1, the participant's kick-off will include a session with a study interventionist. They will also receive an mHealth program.
In stage 2, they will continue with the standard mHealth program, but will also receive counseling from a study interventionist.
干预措施: Counseling (Behavioral)
Human-Enhanced Kick-Off + App + Counseling
This arm includes participants who do not respond to the Human-Enhanced Kick-Off + App in stage 1.
In stage 1, the participant's kick-off will include a session with a study interventionist. They will also receive an mHealth program.
In stage 2, they will continue with the standard mHealth program, but will also receive counseling from a study interventionist.
干预措施: App (Behavioral)
Human-Enhanced Kick-Off + App + Check-In
This arm includes participants who do not respond to the Human-Enhanced Kick-Off + App in stage 1.
In stage 1, the participant's kick-off will include a session with a study interventionist. They will also receive an mHealth program.
In stage 2, they will continue with the mHealth program, but will also receive a check-in with a study interventionist.
干预措施: App (Behavioral)
Fully Automated Kick-Off + App + Counseling
This arm includes participants who do not respond to the Fully Automated Kick-Off + App in stage 1.
In stage 1, participants will receive a Fully Automated Kick-Off and an mHealth program.
In stage 2, they will continue with the standard mHealth program, but will also receive counseling from a study interventionist.
干预措施: App (Behavioral)
Fully Automated Kick-Off + App + Check-In
This arm includes participants who do not respond to the Fully Automated Kick-Off + App in stage 1.
In stage 1, participants will receive a Fully Automated Kick-Off and an mHealth program.
In stage 2, they will continue with the mHealth program, but will also receive a check-in with a study interventionist.
干预措施: App (Behavioral)
Human-Enhanced Kick-Off + App
This arm includes participants who respond to the Human-Enhanced Kick-Off + App in stage 1.
In stage 1, the participant's kick-off will include a session with a study interventionist. They will also receive an mHealth program.
In stage 2, responders to the Human-Enhanced Kick-Off + App will continue with the mHealth program, alone, for the remainder of the study.
干预措施: App (Behavioral)
Fully Automated Kick-Off + App
This arm includes participants who respond to the Fully Automated Kick-Off + App in stage 1.
In stage 1, participants will receive a Fully Automated Kick-Off and an mHealth program.
In stage 2, responders to the Fully Automated Kick-Off + App will continue with the mHealth program, alone, for the remainder of the study.
干预措施: App (Behavioral)
结局指标
主要结局
Feasibility- Rate of early nonresponse
时间窗: 4 weeks
The rate of early response will be calculated as the number of individuals deemed "early responders" divided by the total number of participants randomized.
Feasibility- Percentage of participants with missing data at 4 weeks
时间窗: 4 weeks
The percentage of participants with missing data at 4 weeks will be calculated as the number of participants who do not complete the 4-week weight assessment divided by the total number of participants randomized.
次要结局
- Change in Diet(Baseline, 3 months)
- Weighing Self-Monitoring Adherence(Baseline to 3 months (daily))
- Dietary Self-Monitoring Adherence(Baseline to 3 months (daily))
- Change in Physical Activity(Baseline, 3 months)
- Acceptability- Rate of attendance at human support sessions(Up to 3 months)
- Weight Change- Percent weight change from baseline to 3 months(Baseline, 3 months)
- Weight Change- Percent weight change from 4 weeks to 3 months(4 weeks, 3 months)
- Acceptability- Overall program satisfaction rating(3 months)
- Activity Goal Adherence(Baseline to 3 months (daily))
- Weight Change- Percent weight change from baseline to 4 weeks(Baseline, 4 weeks)
- Acceptability- Attrition(Up to 3 months)
- Physical Activity Self-Monitoring Adherence(Baseline to 3 months (daily))
- Dietary Goal Adherence(Baseline to 3 months (daily))
- Change in Motivation(Baseline, 1 week, 4 weeks, 3 months)