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Completed

NCT Number: NCT04514900

Exploring Optimal Treatment Components for Contactless Online Group-based Behavioral Weight Loss Program

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Carolina

Columbia, South Carolina, 29208, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Video Chat +Personalized Feedback

Behavioral

Participants will receive an online 16-session, goal-driven behavioral weight control program via video chat and weekly interactive modules. The modules provide evidence-based health education on caloric balance, with a goal of fostering changes in diet and exercise habits and producing weight losses of 5-10%. Participants are provided with an electronic scale that will transmit weights wirelessly to a secure study website. A group facilitator will monitor digital food diaries and provide detailed weekly feedback on diet and exercise.

Video Chat + Basic Feedback

Behavioral

Participants will receive an online 16-session, goal-driven behavioral weight control program via video chat and weekly interactive modules. The modules provide evidence-based health education on caloric balance, with a goal of fostering changes in diet and exercise habits and producing weight losses of 5-10%. Participants are provided with an electronic scale that will transmit weights wirelessly to a secure study website. A group facilitator will monitor digital food diaries and provide basic weekly feedback on diet and exercise.

Discussion Board for Social Support +Basic Feedback

Behavioral

Participants will receive an online 16-session, goal-driven behavioral weight control program via weekly interactive modules. The modules provide evidence-based health education on caloric balance, with a goal of fostering changes in diet and exercise habits and producing weight losses of 5-10%. They also are provided with a study discussion board for social support from fellow participants. Participants are provided with an electronic scale that will transmit weights wirelessly to a secure study website. A weight loss counselor will monitor digital food diaries and provide basic weekly feedback on diet and exercise.

Discussion Board for Social Support+Personalized Feedback

Behavioral

Participants will receive an online 16-session, goal-driven behavioral weight control program via weekly interactive modules. The modules provide evidence-based health education on caloric balance, with a goal of fostering changes in diet and exercise habits and producing weight losses of 5-10%. They also are provided with a study discussion board for social support from fellow participants. Participants are provided with an electronic scale that will transmit weights wirelessly to a secure study website. A weight loss counselor will monitor digital food diaries and provide personalized, detailed weekly feedback on diet and exercise.

Primary outcomes

  1. Weight loss

    Time frame: Baseline, 2 and 4 months

    Change in body weight from baseline calculated as kg lost

  2. Change in body weight from baseline calculated as % of body weight lost

    Time frame: 2 and 4 months

    1 - [follow-up body weight/ baseline body weight] = % body weight change

Secondary outcomes

  1. Treatment Engagement: daily weighing

    Time frame: Weeks 1 to 16

    Self-monitoring rates for daily weighing and will be calculated as the total number of days of weight submitted over the 4 month period divided by the total number of days of potential self-weighing.

  2. Treatment Engagement: weekly food journal submissions

    Time frame: Weeks 1 to 16

    Self-monitoring rates for daily dietary self monitoring will be calculated as the total number of weeks of digital food diaries submitted over the 4 month period divided by the total number of weeks of potential digital diary submissions.

  3. Treatment Engagement: completion of the 16 weekly interactive online modules

    Time frame: Weeks 1 to 16

    Percent of weekly module completion will be calculated as the total number of weeks of completed modules submitted over the 4 month period divided by 16 (the total number of modules available).

  4. Treatment Engagement: Attendance at Video Chat condition

    Time frame: Weeks 1 to 16

    Percent of weekly video chat attendance will be calculated as the total number of weeks each participant attended video chat over the 4 month period divided by 16 (the total number of video chats available).- Collected only for those randomized to a condition with video chat

Other outcomes

  1. Supportive Accountability

    Time frame: 2 months and 4 months

    All participants will be administered the Supportive Accountability Questionnaire to determine whether there is a difference in accountability experienced by participants depending on which intervention they receive.

  2. Social Support

    Time frame: baseline, 2 months and 4 months

    All participants will be administered the Perceived Social Support Scale to determine whether perceptions of social support differ depending on which intervention participants receive.

  3. Cost-Effectiveness Analyses

    Time frame: Weeks 1 to 16

    Actual counselor time spent in delivering group video chats and giving feedback will be tracked in order to quantify the relative costs of delivering behavioral weight control programs.

  4. Treatment Expectations

    Time frame: Baseline

    All participants will be queried as to their expectations and preferences in treatment prior to intervention.using a measure designed for the current study

  5. Treatment Satisfaction

    Time frame: through study completion, up to 24 weeks

    Each month participants will be asked to complete a survey inquiring about the helpfulness of the treatment modules, skills building assignments, and satisfaction with their treatment experiences in the previous month. Response options will be a 5-point Likert scale with 1=not at all helpful/useful and 5=extremely helpful/useful on a measure that is developed for this study and tailored to the treatment elements provided.

  6. Self Regulation Questionnaire

    Time frame: baseline

    Participants self report on their self management behaviors

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Collaborators

  • University of Tennessee
  • University of Vermont

Registry information

Official study title

Exploring the Optimal Treatment Components for a Contactless Online Group-based Behavioral Weight Loss Program for the COVID 19 Pandemic

Acronym: iREACH

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 17, 2020
Registry last updated
Apr 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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