Opt-IN: Optimization of Remotely Delivered Intensive Lifestyle Treatment for Obesity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 562
- 试验地点
- 1
- 主要终点
- Weight Change (kg) From Baseline to Month 6, Main Effect of Time
研究概览
简要总结
The overall objective of the proposed research is to use an innovative methodological framework, the Multiphase Optimization Strategy (MOST), to design, for the first time, an optimized, scalable version of a technology-supported intensive lifestyle intervention (INLI) for obesity. MOST involves highly efficient randomized experimentation to assess the effects of individual treatment components, and thereby identify which components and component levels make important contributions to the overall program effect on weight loss. This information then guides assembly of an optimized treatment package that achieves target outcomes with least resource consumption and participant burden. Because the intervention strategies being tested minimize in-person coaching and leverage technology that participants already own, the new optimized intervention, to be called Opt-IN, will be more scalable than traditional INLIs. Opt-IN will thus enjoy greatly increased reach, and enable significant progress in the fight against obesity.
详细描述
The goal of the proposed study is to determine the optimal composition of a technology supported intervention for obesity that minimizes expense and burden to participants, while achieving 6 month weight loss outcomes comparable or superior to those achieved by the current full cost, full burden form of INLIs. All intervention components to be examined were selected based on the Opt-IN model's prediction that they enhance behavioral adherence to weight regulation via the designated pathways. The five components to be tested will be: (1) coaching intensity (12 vs. 24 phone sessions), (2) text messaging (No vs. Yes), (3) progress report to participant's primary care provider (No vs. Yes), (4) recommendation to use meal replacements (No vs. Yes), (5) training participants' self-selected buddies to be supportive (No vs. Yes).
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 and 60 years old
- •BMI 25-40 kg/m2
- •Weight stable (no loss or gain >25 lbs for the past 6 months)
- •Not enrolled in any formal weight loss program or taking anti-obesity medications, but interested in losing weight.
- •Own a Smartphone and be willing to install the Opt-IN app
- •Able to use the app to record dietary intake and weight onto the Smartphone
- •"Buddy" participants must:
- •18 years of age or older
- •Have access to a computer and internet
- •Be willing to undergo "Buddy Training" and participate in 4 webinars
- •Be willing to provide support and encouragement to the participant
排除标准
- •Unstable medical conditions (uncontrolled hypertension, diabetes, unstable angina pectoris, myocardial infarction, transient ischemic attack, cancer undergoing active treatment, or cerebrovascular accident within the past six months)
- •History of diabetes requiring insulin supplementation, Crohn's Disease, or a diagnosis of obstructive sleep apnea requiring intervention (i.e. CPAP)
- •Use an assistive device for mobility (e.g., wheelchair, walker, cane)
- •Plantar fasciitis
- •Hospitalization for a psychiatric disorder within the past 5 years
- •At risk for adverse cardiovascular (CVD) events with moderate intensity activity
- •Cannot read the study questionnaires
- •Committed to following an incompatible dietary regimen
- •Not be pregnant, trying to get pregnant, or lactating
- •Bulimia, binge eating disorder, current substance abuse or dependence (besides nicotine dependence) or report active suicidal ideation
- •Low motivation to change
- •Cannot live with a current or past Opt-IN participant
研究组 & 干预措施
Condition 1
- Lifestyle Core; 2) 12 Telephone Coaching Sessions; 3) Report to Primary Care Physician
干预措施: 12 Telephone Coaching Sessions (Behavioral)
Condition 1
- Lifestyle Core; 2) 12 Telephone Coaching Sessions; 3) Report to Primary Care Physician
干预措施: Report to Primary Care Physician (Behavioral)
Condition 2
- Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendations to use meal replacements; 5) Buddy training via webinars
干预措施: 12 Telephone Coaching Sessions (Behavioral)
Condition 2
- Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendations to use meal replacements; 5) Buddy training via webinars
干预措施: Report to Primary Care Physician (Behavioral)
Condition 2
- Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendations to use meal replacements; 5) Buddy training via webinars
干预措施: Recommendations to use meal replacements (Behavioral)
Condition 2
- Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendations to use meal replacements; 5) Buddy training via webinars
干预措施: Buddy Training (Behavioral)
Condition 3
- Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages; 5) Buddy training via webinars
干预措施: 12 Telephone Coaching Sessions (Behavioral)
Condition 3
- Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages; 5) Buddy training via webinars
干预措施: Report to Primary Care Physician (Behavioral)
Condition 3
- Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages; 5) Buddy training via webinars
干预措施: Text Messages (Behavioral)
Condition 13
- Lifestyle Core; 2) 24 telephone sessions; 3) Buddy training via webinars
干预措施: Buddy Training (Behavioral)
Condition 3
- Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages; 5) Buddy training via webinars
干预措施: Buddy Training (Behavioral)
Condition 4
- Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages
干预措施: 12 Telephone Coaching Sessions (Behavioral)
Condition 4
- Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages
干预措施: Report to Primary Care Physician (Behavioral)
Condition 4
- Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages
干预措施: Text Messages (Behavioral)
Condition 4
- Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages
干预措施: Recommendations to use meal replacements (Behavioral)
Condition 5
- Lifestyle Core; 2) 12 telephone sessions; 3) Buddy training via webinars
干预措施: 12 Telephone Coaching Sessions (Behavioral)
Condition 5
- Lifestyle Core; 2) 12 telephone sessions; 3) Buddy training via webinars
干预措施: Buddy Training (Behavioral)
Condition 6
- Lifestyle Core; 2) 12 telephone coaching sessions; 3) Recommendations to use meal replacements
干预措施: 12 Telephone Coaching Sessions (Behavioral)
Condition 6
- Lifestyle Core; 2) 12 telephone coaching sessions; 3) Recommendations to use meal replacements
干预措施: Recommendations to use meal replacements (Behavioral)
Condition 7
- Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages
干预措施: 12 Telephone Coaching Sessions (Behavioral)
Condition 7
- Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages
干预措施: Text Messages (Behavioral)
Condition 8
- Lifestyle Core; 2) 12 telephone sessions; 3) Recommendation to use meal replacements; 4) Regular text messages, 5) Buddy training via webinars
干预措施: Text Messages (Behavioral)
Condition 8
- Lifestyle Core; 2) 12 telephone sessions; 3) Recommendation to use meal replacements; 4) Regular text messages, 5) Buddy training via webinars
干预措施: 12 Telephone Coaching Sessions (Behavioral)
Condition 8
- Lifestyle Core; 2) 12 telephone sessions; 3) Recommendation to use meal replacements; 4) Regular text messages, 5) Buddy training via webinars
干预措施: Recommendations to use meal replacements (Behavioral)
Condition 8
- Lifestyle Core; 2) 12 telephone sessions; 3) Recommendation to use meal replacements; 4) Regular text messages, 5) Buddy training via webinars
干预措施: Buddy Training (Behavioral)
Condition 9
- Lifestyle Core; 2) 24 telephone coaching sessions; 3) Report to Primary Care Physician
干预措施: 24 Telephone Coaching Sessions (Behavioral)
Condition 9
- Lifestyle Core; 2) 24 telephone coaching sessions; 3) Report to Primary Care Physician
干预措施: Report to Primary Care Physician (Behavioral)
Condition 10
- Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Buddy training via webinars
干预措施: 24 Telephone Coaching Sessions (Behavioral)
Condition 10
- Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Buddy training via webinars
干预措施: Report to Primary Care Physician (Behavioral)
Condition 10
- Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Buddy training via webinars
干预措施: Recommendations to use meal replacements (Behavioral)
Condition 10
- Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Buddy training via webinars
干预措施: Buddy Training (Behavioral)
Condition 11
- Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages; 5) Buddy training via webinars
干预措施: 24 Telephone Coaching Sessions (Behavioral)
Condition 11
- Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages; 5) Buddy training via webinars
干预措施: Report to Primary Care Physician (Behavioral)
Condition 11
- Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages; 5) Buddy training via webinars
干预措施: Text Messages (Behavioral)
Condition 11
- Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages; 5) Buddy training via webinars
干预措施: Buddy Training (Behavioral)
Condition 12
- Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages
干预措施: 24 Telephone Coaching Sessions (Behavioral)
Condition 12
- Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages
干预措施: Report to Primary Care Physician (Behavioral)
Condition 12
- Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages
干预措施: Text Messages (Behavioral)
Condition 12
- Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages
干预措施: Recommendations to use meal replacements (Behavioral)
Condition 13
- Lifestyle Core; 2) 24 telephone sessions; 3) Buddy training via webinars
干预措施: 24 Telephone Coaching Sessions (Behavioral)
Condition 14
- Lifestyle Core; 2) 24 telephone coaching sessions; 3) Recommendation to use meal replacements
干预措施: 24 Telephone Coaching Sessions (Behavioral)
Condition 14
- Lifestyle Core; 2) 24 telephone coaching sessions; 3) Recommendation to use meal replacements
干预措施: Recommendations to use meal replacements (Behavioral)
Condition 15
- Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages
干预措施: 24 Telephone Coaching Sessions (Behavioral)
Condition 15
- Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages
干预措施: Text Messages (Behavioral)
Condition 16
- Lifestyle Core; 2) 24 telephone sessions; 3) Recommendation to use meal replacements; 4) Regular text messages, 5) Buddy training via webinars
干预措施: 24 Telephone Coaching Sessions (Behavioral)
Condition 16
- Lifestyle Core; 2) 24 telephone sessions; 3) Recommendation to use meal replacements; 4) Regular text messages, 5) Buddy training via webinars
干预措施: Text Messages (Behavioral)
Condition 16
- Lifestyle Core; 2) 24 telephone sessions; 3) Recommendation to use meal replacements; 4) Regular text messages, 5) Buddy training via webinars
干预措施: Recommendations to use meal replacements (Behavioral)
Condition 16
- Lifestyle Core; 2) 24 telephone sessions; 3) Recommendation to use meal replacements; 4) Regular text messages, 5) Buddy training via webinars
干预措施: Buddy Training (Behavioral)
Condition 17
- Lifestyle Core; 2) 12 Telephone Coaching Sessions
干预措施: 12 Telephone Coaching Sessions (Behavioral)
Condition 18
- Lifestyle Core; 2) 12 telephone sessions; 3) Recommendations to use meal replacements; 4) Buddy training via webinars
干预措施: 12 Telephone Coaching Sessions (Behavioral)
Condition 18
- Lifestyle Core; 2) 12 telephone sessions; 3) Recommendations to use meal replacements; 4) Buddy training via webinars
干预措施: Recommendations to use meal replacements (Behavioral)
Condition 18
- Lifestyle Core; 2) 12 telephone sessions; 3) Recommendations to use meal replacements; 4) Buddy training via webinars
干预措施: Buddy Training (Behavioral)
Condition 19
- Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages; 4) Buddy training via webinars
干预措施: 12 Telephone Coaching Sessions (Behavioral)
Condition 19
- Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages; 4) Buddy training via webinars
干预措施: Text Messages (Behavioral)
Condition 19
- Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages; 4) Buddy training via webinars
干预措施: Buddy Training (Behavioral)
Condition 20
- Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages; 4) Recommendation to use meal replacements
干预措施: 12 Telephone Coaching Sessions (Behavioral)
Condition 20
- Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages; 4) Recommendation to use meal replacements
干预措施: Text Messages (Behavioral)
Condition 20
- Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages; 4) Recommendation to use meal replacements
干预措施: Recommendations to use meal replacements (Behavioral)
Condition 21
- Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Buddy training via webinars
干预措施: Report to Primary Care Physician (Behavioral)
Condition 21
- Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Buddy training via webinars
干预措施: Buddy Training (Behavioral)
Condition 22
- Lifestyle Core; 2) 12 telephone coaching sessions; 3) Report to Primary Care Physician; 4) Recommendations to use meal replacements
干预措施: Report to Primary Care Physician (Behavioral)
Condition 23
- Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages
干预措施: 12 Telephone Coaching Sessions (Behavioral)
Condition 23
- Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages
干预措施: Report to Primary Care Physician (Behavioral)
Condition 23
- Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages
干预措施: Text Messages (Behavioral)
Condition 24
- Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages, 6) Buddy training via webinars
干预措施: Text Messages (Behavioral)
Condition 24
- Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages, 6) Buddy training via webinars
干预措施: 12 Telephone Coaching Sessions (Behavioral)
Condition 24
- Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages, 6) Buddy training via webinars
干预措施: Report to Primary Care Physician (Behavioral)
Condition 24
- Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages, 6) Buddy training via webinars
干预措施: Recommendations to use meal replacements (Behavioral)
Condition 24
- Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages, 6) Buddy training via webinars
干预措施: Buddy Training (Behavioral)
Condition 25
- Lifestyle Core; 2) 24 telephone coaching sessions
干预措施: 24 Telephone Coaching Sessions (Behavioral)
Condition 26
- Lifestyle Core; 2) 24 telephone sessions; 3) Recommendation to use meal replacements; 4) Buddy training via webinars
干预措施: 24 Telephone Coaching Sessions (Behavioral)
Condition 26
- Lifestyle Core; 2) 24 telephone sessions; 3) Recommendation to use meal replacements; 4) Buddy training via webinars
干预措施: Recommendations to use meal replacements (Behavioral)
Condition 26
- Lifestyle Core; 2) 24 telephone sessions; 3) Recommendation to use meal replacements; 4) Buddy training via webinars
干预措施: Buddy Training (Behavioral)
Condition 27
- Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages; 4) Buddy training via webinars
干预措施: 24 Telephone Coaching Sessions (Behavioral)
Condition 27
- Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages; 4) Buddy training via webinars
干预措施: Text Messages (Behavioral)
Condition 27
- Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages; 4) Buddy training via webinars
干预措施: Buddy Training (Behavioral)
Condition 28
- Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages; 4) Recommendation to use meal replacements
干预措施: 24 Telephone Coaching Sessions (Behavioral)
Condition 28
- Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages; 4) Recommendation to use meal replacements
干预措施: Text Messages (Behavioral)
Condition 28
- Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages; 4) Recommendation to use meal replacements
干预措施: Recommendations to use meal replacements (Behavioral)
Condition 29
- Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Buddy training via webinars
干预措施: 24 Telephone Coaching Sessions (Behavioral)
Condition 29
- Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Buddy training via webinars
干预措施: Report to Primary Care Physician (Behavioral)
Condition 29
- Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Buddy training via webinars
干预措施: Buddy Training (Behavioral)
Condition 30
- Lifestyle Core; 2) 24 telephone coaching sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements
干预措施: 24 Telephone Coaching Sessions (Behavioral)
Condition 30
- Lifestyle Core; 2) 24 telephone coaching sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements
干预措施: Report to Primary Care Physician (Behavioral)
Condition 30
- Lifestyle Core; 2) 24 telephone coaching sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements
干预措施: Recommendations to use meal replacements (Behavioral)
Condition 31
- Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages
干预措施: 24 Telephone Coaching Sessions (Behavioral)
Condition 31
- Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages
干预措施: Report to Primary Care Physician (Behavioral)
Condition 31
- Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages
干预措施: Text Messages (Behavioral)
Condition 32
- Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages, 6) Buddy training via webinars
干预措施: 24 Telephone Coaching Sessions (Behavioral)
Condition 32
- Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages, 6) Buddy training via webinars
干预措施: Report to Primary Care Physician (Behavioral)
Condition 32
- Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages, 6) Buddy training via webinars
干预措施: Text Messages (Behavioral)
Condition 32
- Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages, 6) Buddy training via webinars
干预措施: Recommendations to use meal replacements (Behavioral)
Condition 32
- Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages, 6) Buddy training via webinars
干预措施: Buddy Training (Behavioral)
结局指标
主要结局
Weight Change (kg) From Baseline to Month 6, Main Effect of Time
时间窗: From Baseline to Month 6
Estimated mean change from Baseline to Month 6 were obtained from a linear mixed models analysis of variance to account for missing data. All randomized participants were utilized in the model (ITT analysis).
Weight Change (kg) From Baseline to Month 6, Time by Factor Interaction
时间窗: From Baseline to Month 6
Estimated mean change from Baseline to Month 6 were obtained from a linear mixed models analysis of variance to account for missing data. All randomized participants were utilized in the model (ITT analysis). This outcome measure is reported as an additional effect beyond that of Outcome Measure 1 (each component has it's own weight loss effect that is above and beyond the weight change calculated in the Outcome Measure 1 analyses).
次要结局
- Intervention for <$500(6 months)
研究者
Bonnie Spring
Professor
Northwestern University