Rapid Evaluation of Innovative Intervention Components to Maximize the Health Benefits of Behavioral Obesity Treatment Delivered Online: An Application of Multiphase Optimization Strategy

Overweight and Obesity Clinical Trial

Official title:

Rapid Evaluation of Innovative Intervention Components to Maximize the Health Benefits of Behavioral Obesity Treatment Delivered Online: An Application of Multiphase Optimization Strategy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04520256
• Other study ID #: R01DK117857
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 22, 2020
• Est. completion date: May 18, 2023

Study information

• Verified date: March 2024
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

When delivered online, behavioral obesity treatments have the potential to reach large numbers of individuals with overweight/obesity and produce significant improvements in health and wellbeing. In order to maximize the public health benefit of disseminating these treatments online, this study will use the Multiphase Optimization Strategy (MOST) framework to most quickly and efficiently determine which, if any, of 5 innovative intervention components, alone or in combination, increases the proportion of patients achieving a ≥5% weight loss, and mean weight loss, after a 12-month online behavioral obesity treatment.

Description:

Decades of research have demonstrated that behavioral obesity treatments can produce clinically significant weight losses that improve health and disease risk/severity. However, these treatments have not been disseminated widely due to high costs and lack of qualified providers. The investigators therefore aim to develop and test a fully automated online obesity treatment that would produce clinically significant weight losses (i.e., ≥ 5 % of initial body weight) when delivered online. In order to maximize the public health impact of online obesity treatment, and advance the science of online behavioral intervention in general, it is imperative to evaluate innovative behavioral intervention components with the potential to optimize weight loss outcomes. Because digital health technology evolves rapidly, this research will use the Multiphase Optimization Strategy (MOST) framework to most quickly and efficiently determine which, if any, of 5 innovative intervention components, alone or in combination, increases the proportion of patients achieving a ≥5% weight loss, and mean weight loss, of the online Rx Weight loss (RxWL) program at 12- months. The 5 intervention components to be tested are: (a) Web-based virtual reality intervention for training in basic behavioral weight loss skills; tailored interactive intervention targeting (b) structured physical activity and (c) dysregulated eating; (d) a platform for social interaction including opportunities for friendly competition, and (e) interactive video feedback with content tailored to the unique needs of each participant and a focus on dietary skills. A sample of 384 individuals with BMI ≥ 25 will be randomized to receive RxWL and 0-5 of the experimental intervention components in a full factorial experiment. This design will allow the investigators to determine which intervention components maximize weight loss and whether there are favorable combinations of components. In addition, by evaluating the effects of each component on proximal outcomes (i.e., mediators) it will be possible learn not only which components are (or are not) effective but also why or how they exert their effects. This project advances the science of behavioral obesity treatment, and will directly impact the care of patients receiving RxWL.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 384
• Est. completion date: May 18, 2023
• Est. primary completion date: May 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

• English language fluent and literate at the 6th grade level
• Body mass index (BMI) between 25 and 50 kg/m-squared
• Able to walk 2 city blocks without stopping
• Not currently participating in another weight loss program
• Not currently taking weight loss medication
• Has not lost =5% of body weight in the 6 months prior to enrolling
• Has not been pregnant within the 6 months prior to enrolling
• Does not plan to become pregnant within 12 months of enrolling
• Denies having a heart condition, chest pain during periods of activity or rest, or loss of consciousness in the 12 months prior to enrolling
• Denies any medical condition that would affect the safety of participating in unsupervised physical activity
• Denies any condition that would result in inability to follow the study protocol, including terminal illness, substance abuse, eating disorder (not including Binge Eating Disorder) and untreated major psychiatric illness

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• Online Behavioral Weight Loss Program
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
• Virtual Reality for Behavioral Weight Loss Skills Training
This program allows participants to practice behavioral weight loss skills using an online virtual reality system accessed via a Web browser.
• Tailored Interactive Video Feedback
Video-recorded messages are used to provide periodic feedback on progress with weight loss, dietary change, and physical activity. Additional videos provide dietary skills training.
• Tailored Intervention for Structured Physical Activity
Periodic self-assessment is used to guide selection of a physical activity goal. Home-based instructional videos are provided to help meet the selected goal.
• Skills Training for Dysregulated Eating
Periodic self-assessment is used to guide selection of skills training modules designed to counter common causes of dysregulated eating (e.g., boredom, stress).
• Platform for Social Support & Friendly Competition
An online platform is provided for participants to connect with each other, support each other, and compete on achievement of behavioral and weight loss milestones.

Locations

Country	Name	City	State
United States	Miriam Hospital Weight Control and Diabetes Resarch Center	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
The Miriam Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean weight change (percent of initial body weight)		12-month end of treatment
Primary	Proportion of participants achieving at least 5% weight loss		12-month end of treatment
Secondary	Weight loss self-efficacy	Measured via the Weight Efficacy Life-Style Questionnaire (WEL). Scores range from 0 to 180; higher scores indicate a better outcome.	12-month end of treatment
Secondary	Supportive accountability	Measured via the Supportive Accountability Measure (SAM). Scores range from 17.14 to 100; higher scores indicate a better outcome.	12-month end of treatment
Secondary	Social support for diet and exercise behaviors	Measured via the Scales to Measure Social Support for Diet and Exercise Behaviors. Scores range from 10 to 75; higher scores indicate a better outcome.	12-month end of treatment
Secondary	Internal disinhibition	Measured via the Eating Inventory. Scores range from 0 to 16; lower scores indicate a better outcome.	12-month end of treatment
Secondary	Structured physical activity	Daily time spent in structured moderate to vigorous intensity physical activity will be measured using the ActiGraph GT9X Link	12-month end of treatment
Secondary	Dietary quality	Data collected via the National Cancer Institute Automated Self-Administered 24-hour recall system (ASA-24). Diet quality is measured by the The Health Eating Index, 2015, score that reflects conformance to the 2015 Dietary Guidelines for Americans. Higher scores indicate a better outcome.	12-month end of treatment
Secondary	Dietary energy density	Data collected via the National Cancer Institute Automated Self-Administered 24-hour recall system (ASA-24). Energy density of the diet is calculated as total energy intake from food ÷ total weight of the food. Lower scores indicate a better outcome.	12-month end of treatment