Remote Approaches for Optimizing Weight Loss (Elevate Weight Loss Trial)

Официальное название

Comparison of Behaviorally-Based Remote Approaches to Optimize Weight Loss and Identification of Factors Which Characterize Treatment Response

Обзор

The purpose of this trial is to compare two delivery formats for weight loss (automated online program vs. group-based videoconference program) and to examine the added effect of individual coaching (vs. no coaching) for individuals with overweight or obesity. All participants enrolled in this study will receive a 12-month behavioral weight loss program (varying in delivery format and individual support), and will be provided with weight loss, calorie intake, and exercise goals. Assessments will occur at baseline, 6 (mid-treatment), 12 (post-treatment), and 18 months (following 6 months of no intervention). We will also seek to determine which combination of intervention approaches works best for whom and develop algorithms which can be used to refer patients into remote programs in clinical settings or future trials.

Подробное описание

Participants will be randomized at baseline to one of four weight loss intervention conditions: 1) automated program + coaching, 2) automated program + no coaching, 3) group videoconference program + coaching, and 4) group videoconference program + no coaching. All participants will be provided with weekly goals, instructed to self-monitor diet, exercise, and weight daily, and provided with feedback based upon these data. Those receiving the online program will also be instructed to view video lessons (24 in total, 10-15 min each) which focus on behavioral strategies for changing diet and exercise. Individuals randomized to the videoconference program will participate in 24 group sessions (1 hour each) designed to mimic in-person treatment and allow for participant interaction via large and small group discussions. The content across conditions will be similar and the lessons will be provided weekly during months 1-3, twice per month during months 4-6, and monthly during months 7-12. Those receiving coaching will have individual, monthly meetings with a coach via videoconference (\~15 min each). Coaching sessions will focus on individual barriers, problem solving, goal setting, and fostering support and accountability.

The primary aim of this study is to examine the effects of delivery format (automated online vs. videoconference) and coaching (individualized vs. none) on weight loss at 12 months. Secondary aims will examine the effects of delivery format and coaching on intervention engagement (e.g., frequency of self-monitoring), psychosocial outcomes (e.g., perceived support, self-efficacy, and motivation), 18-month weight loss, and the cost per kilogram of weight loss (to examine whether the addition of human support is cost-effective). Two algorithms will also be developed to predict which treatment type should be recommended to whom, using only baseline characteristics: 1) a 'widely-applicable' algorithm which will use metrics common to electronic medical records (sex, BMI, age, race, ethnicity), and 2) a 'more comprehensive' algorithm which will further include additional baseline characteristics (e.g., education, household income, health literacy, group preference, etc).

Вмешательства

• Поведенческое Automated online weight loss program
  Participants receiving this program are given a daily calorie intake goal of 1200-1800 kcal/day based upon their starting weight and a moderate-intensity aerobic exercise (e.g., walking) goal which progresses to 250 min/week. They are instructed to self-monitor body weight, calorie intake, and exercise minutes daily over 12 months, and are provided with a smart scale for electronic transmission of weight data. Computer-generated, personalized feedback is based upon self-monitoring data, and prov
• Поведенческое Individual coaching
  Participants will receive monthly, one-on-one coaching sessions (12 in total) throughout the 12-month intervention period. Coaching sessions will be conducted via videoconference and the initial coaching session will be approximately 30 minutes and all remaining sessions will be approximately 15 minutes. The structure of the coaching sessions will be similar across participants, but the content will be tailored to the individual. Coaches will use goal setting, problem solving, and motivational i
• Поведенческое Group-based, videoconference-delivered weight loss
  Participants receiving this program will be instructed to attend interactive group videoconference sessions (60 minutes each) focused on behavioral strategies for changing diet and exercise to promote weight loss. Classes will be weekly during months 1-3, twice per month during months 4-6, and monthly during months 7-12. These classes are designed to allow participants to interact with, support, and learn from one another. Participants are also given a daily calorie intake goal of 1200-1800 kcal

Первичные конечные точки

• Percent weight change [Срок оценки: 12 months]
• Change in perceived support [Срок оценки: 12 months]

Вторичные конечные точки (8)

• Cost per kilogram of weight loss [Срок оценки: 12 months]
• Percent weight change [Срок оценки: 18 months]
• Frequency of self-monitoring weight [Срок оценки: 12 months]
• Self-monitoring of calorie intake [Срок оценки: 12 months]
• Change in self-efficacy for diet [Срок оценки: 12 months]
• Self-efficacy for exercise [Срок оценки: 12 months]
• Change in autonmous motivation [Срок оценки: 12 months]
• Change in controlled motivation [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Body Mass Index between 25-45 kg/m2
• Daily, home Internet access

Критерии исключения

• Currently pregnant, planning to become pregnant within the next 18 months, or pregnant within the past 6 months
• Current or recent enrollment (<2 years) in a weight loss program
• Presence of any medical condition for which exercise, weight loss, or dietary restriction is contraindicated
• Recent weight loss (≥10 pounds within the past 6 months)
• Currently taking weight loss medications or history of bariatric surgery
• Inability to walk 2 blocks without stopping
• Non-English speaking
• A member of one's household is participating in the study
• History of anorexia or bulimia nervosa

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The Miriam Hospital's Weight Control and Diabetes Research Center — Providence

Идентификаторы

NCT: NCT06875622 · 2185718

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗