Clinical trial NCT04514900: Exploring Optimal Treatment Components for Contactless Online Group-based Behavioral Weight Loss Program
Official title: Exploring the Optimal Treatment Components for a Contactless Online Group-based Behavioral Weight Loss Program for the COVID 19 Pandemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: weight loss
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: University of Vermont
name: University of Tennessee
First posted: 2020-08-17
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: A 2x2 randomized controlled pilot study will be conducted which randomly allocates 73 individuals with overweight or obesity to an online weight control program and varies whether they receive asynchronous social support (discussion board) vs synchronous plus asynchronous social support (weekly video chat + discussion board) and varies whether the type of feedback which they receive on their self-monitoring (detailed vs basic) in a factorial study. All participants will receive the core 16-week online interactive behavioral weight loss program (iREACH) and will be followed for 4 months with monthly surveys and weight ascertainment.
Primary purpose: TREATMENT

Brief summary: The current pilot study will explore the optimal cost-effective treatment configuration for online group-based weight control by focusing on two aspects of our existing treatment program which have significant associated cost and determine which contribute meaningfully to weight loss outcomes. Specifically, we will explore whether adding synchronous group social support (weekly group video chat sessions facilitated by a trained weight loss counselor) to on demand (asynchronous) social support provided through the program discussion board significantly increases weight losses achieved. We will also examine whether detailed feedback on dietary and physical activity self-monitoring records from a counselor enhances weight loss outcomes in comparison with basic feedback. Finally, we will examine the cost efficiency of the treatment constellations. Further, this pilot study will also explore the feasibility of recruiting participants nationally (rather than just locally) and the capture of data electronically (including body weight measurements) without any in-person contact.

Detailed description: All participants will receive the same online group-based weight loss program, a lifestyle intervention which we have demonstrated to be effective in the past. The 16-session, goal-driven behavioral weight control program offers weekly interactive modules that provide evidence-based health education on caloric balance and physical activity increases, with a goal of fostering changes in diet and exercise habits and producing weight losses of 5-10%. The intervention is based on social cognitive theory and uses a self-regulation approach to learning new lifestyle habits that can produce and maintain weight loss. Participants in all study arms will be provided with the same calorie and physical activity goals, and all participants will be asked to self-monitor their dietary intake and physical activity daily using an app on their smart phone. They will also be asked to weigh themselves daily, consistent with research indicating that daily weighing is associated with greater weight loss and participants will be provided with a Bluetooth-enabled "smart scale" that will communicate weight to the password-protected study website (visible to only the participant and study staff). The study website also provides the dynamic programmatic content, real time graphic feedback from self-monitoring (for each individual participant) and a study group discussion board for asynchronous group interactions and social support. The website includes the core aspects of the behavioral program and is to be provided to all participants.

Eligibility criteria: Inclusion Criteria:

* BMI between 27-55 kg/m2
* free of medical problems that might contraindicate participation in a behavioral weight reduction program containing an exercise component
* must have a computer at home or work with video camera and access to the internet
* must have a smart phone
* only one member of a household may participate
* must successfully complete a self-monitoring diary of food and beverages consumed for 7 consecutive days
* must successfully set up the electronic scale (provided by the study at no cost) and transmit a body weight to study staff
* must agree to be randomized to any of the 4 groups
* must be willing to share access to their dietary and physical activity self-monitoring information collected via the Fitbit.com app/website and their weight data collected via linking the electronic smart scale with Fitbit.com

Exclusion Criteria:

* taking insulin
* currently on medication that might affect weight loss
* currently pregnant or pregnant in the previous 6 months
* currently breastfeeding
* enrolled in another weight reduction program
* have had a heart attack or stroke in the past 6 months
* ever had weight loss surgery
* have lost more than 10 pounds in the previous 6 months
* currently taking medications for weight loss
* required by their doctor to follow a special diet (other than a low fat diet)
* anyone who has a schedule that would make it difficult to attend scheduled "chat" groups, should they be randomized to receive that treatment component

Primary outcomes:
measure: Weight loss
timeFrame: Baseline, 2 and 4 months
measure: Change in body weight from baseline calculated as % of body weight lost
timeFrame: 2 and 4 months
Secondary outcomes:
measure: Treatment Engagement: daily weighing
timeFrame: Weeks 1 to 16
measure: Treatment Engagement: weekly food journal submissions
timeFrame: Weeks 1 to 16
measure: Treatment Engagement: completion of the 16 weekly interactive online modules
timeFrame: Weeks 1 to 16
measure: Treatment Engagement: Attendance at Video Chat condition
timeFrame: Weeks 1 to 16
Other outcomes:
measure: Supportive Accountability
timeFrame: 2 months and 4 months
measure: Social Support
timeFrame: baseline, 2 months and 4 months
measure: Cost-Effectiveness Analyses
timeFrame: Weeks 1 to 16
measure: Treatment Expectations
timeFrame: Baseline
measure: Treatment Satisfaction
timeFrame: through study completion, up to 24 weeks
measure: Self Regulation Questionnaire
timeFrame: baseline
Locations:
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
affiliation: University of South Carolina
name: Delia West, PhD
role: PRINCIPAL_INVESTIGATOR
References: