Overweight and ObesityiREACHNCT06105957
Optimal Digital Weight Loss Treatment for Rural Individuals
A study testing Core, Facilitated Weekly Group Sessions and Counselor Crafted Feedback in people with Overweight and Obesity, run by University of South Carolina at 1 site in United States.
Trial summary
Over 130 million adults in the US experience overweight and obesity, and rural communities experience significantly higher rates of obesity and related chronic diseases. Although lifestyle interventions successfully produce clinically significant weight losses, the availability of weight management programs is limited… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Core, Facilitated Weekly Group Sessions and Counselor Crafted Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 616 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- have a body mass index [BMI] > 25-55 kg/m2;
- home address in a zip code classified as non-urban; classification of an individual as living in a non-urban area will be determined by meeting any one of the following criteria: (1) having a home address corresponding to a Rural-Urban Commuting Area [RUCA] code of 4-10); (2) qualifying as rural under the Centers for Medicare and Medicaid Services Rural Health Clinic Program based on the 2010 or 2020 Census Bureau data; or (3) meeting the definition of rural from the Federal Office of Rural Health Policy;
- have no physical limitations that prevent walking at a moderate pace for at least 10 minutes without stopping;
- be able to provide informed consent;
- have access to a smartphone and a computer or tablet with a video camera and stable access to the Internet (at home or work or some other stable source of access);
- complete all screening and baseline questionnaires and activities.
Who cannot join
- only one member of a household may participate concurrently.
- currently participating in another weight loss program, taking a weight loss medication, have a history of bariatric surgery, or lost ≥ 10 pounds during the past 6-months;
- are pregnant, lactating, less than 6 months post-partum, or plan to become pregnant during the time frame of the investigation;
- report a medical condition that would affect the safety and/or efficacy of a weight management program involving diet and physical activity (e.g., uncontrolled heart condition, dementia, bulimia nervosa or binge eating disorder, or other significant psychiatric problems);
- or report conditions that in the judgment of the one of the Principal Investigators (MPIs) would render them unlikely to be able to independently follow the intervention protocol for 6 months, including conditions which might comprise their ability to engage independently with the intervention website materials, provide self-monitoring information on a smartphone app, attend Zoom video group or individual sessions at the available times (if randomized to receive these treatment components), and complete online questionnaires.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina
Columbia, South Carolina, 29208
About this study
Official title: Addressing Rural Health Disparities by Optimizing "High Touch" Intervention Components in Digital Obesity Treatment
Over 130 million adults in the US experience overweight and obesity, and rural communities experience significantly higher rates of obesity and related chronic diseases. Although lifestyle interventions successfully produce clinically significant weight losses, the availability of weight management programs is limited in rural areas. Digital interventions offer an attractive alternative for delivering lifestyle programs to rural populations. However, in-person behavioral obesity treatment programs achieve better weight losses than digital programs, likely because in-person programs typically include personnel-intensive "high touch" treatment components. Some studies indicate that having a human "behind the curtain" of a digital program through emailed feedback or with the addition of online group sessions can significantly increase weight loss. Therefore, the aims of this study are to increase the public health impact of digital obesity treatment for rural populations by simultaneously investigating 3 "high touch" intervention components. The investigators will conduct a highly efficient experiment with participants residing in non-urban areas recruited online from across the United States. Participants (N=616; 22% racial/ethnic minority; 40% male) will be randomized to: (1) weekly facilitated synchronous group video sessions (yes vs. no); (2) type of self-monitoring feedback received (counselor-crafted vs. pre-scripted); and (3) individual coaching calls (yes vs. no). These components will be layered onto our 24-week evidence-based, interactive digital weight loss program delivered to groups of eligible individuals. Based on the results of the experiment, The investigators will identify an optimized program in which each component (or combination of components) contributes meaningfully (at least 1.5 kg greater weight loss at 6-months) to enhanced weight loss. The investigators will also exploratory analyses of weight trajectories 6-months post-treatment (i.e., at 12-months) to elucidate extended impact of the specific components on weight control. Ultimately, this research will set the stage for confirming the most promising digital behavioral weight loss intervention that can be used without geographic borders to reduce obesity rates among rural residents and provide the evidence needed to establish best practice policies for broadly effective digital approaches to weight control.
- Conditions
- Overweight and Obesity
- Being tested
- Core, Facilitated Weekly Group Sessions, Counselor Crafted Feedback, Individual Coaching Calls, Pre-Scripted Feedback
- Keywords
- behavioral weight control, weight management, online weight loss program
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoreBehavioural
The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals. Weekly tips and discussion board postings invite participants to apply skills introduced in the modules and prompt interaction and social support within the closed group which starts the program simultaneously.
Facilitated Weekly Group SessionsBehavioural
Participants will receive 24 facilitated online video-conference-based weekly group sessions. These groups will be 60 minutes long and will be facilitated by a trained professional, who reinforces the information and behavioral strategies introduced in the weekly modules, elicits the experiences of participants in applying behavioral skills to establish new diet and exercise habits, and guides problem solving. Group cohesion to offer social support is promoted.
Counselor Crafted FeedbackBehavioural
Participants will receive up to 24 weekly messages that are crafted by a trained professional based on their dietary, physical activity, and weight monitoring for the week as well as their completion of online modules, to construct an individualized feedback message. The emailed feedback will provide positive reinforcement for successful goal achievement, identify possible areas for improvement, and suggest possible strategies for identified challenges.
Individual Coaching CallsBehavioural
Participants will receive 3 online one-on-one coaching calls to focus on identifying and addressing challenges to successful behavior change and weight loss. The first call will emphasize amplifying motivation and promoting early treatment engagement by establishing rapport, exploring personal reasons for weight loss and lifestyle change, and reinforcing and expanding change talk, and it will occur prior to starting the core program. Subsequent calls will use a motivational interviewing-informed approach to problem solve barriers to self-monitoring, particularly dietary self-monitoring because of the strong role it plays in promoting better weight loss and will occur during the first half of the program, reflecting the critical role of early engagement in the treatment program on long term weight loss success. Coaching calls will be of approximately 30 min duration and will follow a semi-structured interview format.
Pre-Scripted FeedbackBehavioural
Participants will receive up to 24 weekly messages constructed from a bank of pre-scripted messages that align with success, partial success, or absence of self-monitoring within each of the following domains: dietary monitoring, physical activity monitoring, and self-weighing, as well as on weekly module completion. Feedback is automatically generated based on decision algorithms and will be sent from program staff.
| Study group | Role | What they receive |
|---|---|---|
| Core+Facilitated Weekly Group Sessions+Counselor Crafted Feedback+Individual Coaching Calls | Experimental | Behavioral: Core The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals.
Behavioral: Facilitated Weekly Group Sessions Participants will receive 24, 60-minute facilitated online video-conference-based weekly group sessions.
Behavioral: Counselor Crafted Feedback Participants will receive up to 24 weekly messages that are crafted by a trained professional based on their dietary, physical activity, and weight monitoring for the week as well as their completion of online modules, to construct an individualized feedback message.
Behavioral: Individual Coaching Calls Participants will receive 3 30-minute online one-on-one coaching calls to focus on identifying and addressing challenges to successful behavior change and weight loss. Receives: Behavioral: Core; Behavioral: Facilitated Weekly Group Sessions; Behavioral: Counselor Crafted Feedback; Behavioral: Individual Coaching Calls |
| Core+Facilitated Weekly Group Sessions+Pre-Scripted Feedback | Experimental | Behavioral: Core The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals.
Behavioral: Facilitated Weekly Group Sessions Participants will receive 24, 60-minute facilitated online video-conference-based weekly group sessions.
Behavioral: Pre-Scripted Feedback Participants will receive up to 24 weekly messages constructed from a bank of pre-scripted messages that align with success, partial success, or absence of self-monitoring related to diet monitoring, physical activity, and self-weighing, as well as on weekly module engagement. Receives: Behavioral: Core; Behavioral: Facilitated Weekly Group Sessions; Behavioral: Pre-Scripted Feedback |
| Core+Facilitated Weekly Group Sessions+Pre-Scripted Feedback+Individual Coaching Calls | Experimental | Behavioral: Core The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals.
Behavioral: Facilitated Weekly Group Sessions Participants will receive 24, 60-minute facilitated online video-conference-based weekly group sessions.
Behavioral: Pre-Scripted Feedback Participants will receive up to 24 weekly messages constructed from a bank of pre-scripted messages that align with success, partial success, or absence of self-monitoring related to diet monitoring, physical activity, and self-weighing, as well as on weekly module engagement.
Behavioral: Individual Coaching Calls Participants will receive 3 30-minute online one-on-one coaching calls to focus on identifying and addressing challenges to successful behavior change and weight loss. Receives: Behavioral: Core; Behavioral: Facilitated Weekly Group Sessions; Behavioral: Individual Coaching Calls; Behavioral: Pre-Scripted Feedback |
| Core+Facilitated Weekly Group Sessions+Counselor Crafted Feedback | Experimental | Behavioral: Core The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals.
Behavioral: Facilitated Weekly Group Sessions Participants will receive 24, 60-minute facilitated online video-conference-based weekly group sessions.
Behavioral: Counselor Crafted Feedback Participants will receive up to 24 weekly messages that are crafted by a trained professional based on their dietary, physical activity, and weight monitoring for the week as well as their completion of online modules, to construct an individualized feedback message. Receives: Behavioral: Core; Behavioral: Facilitated Weekly Group Sessions; Behavioral: Counselor Crafted Feedback |
| Core+ Counselor Crafted Feedback+Individual Coaching Calls | Experimental | Behavioral: Core The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals.
Behavioral: Counselor Crafted Feedback Participants will receive up to 24 weekly messages that are crafted by a trained professional based on their dietary, physical activity, and weight monitoring for the week as well as their completion of online modules, to construct an individualized feedback message.
Behavioral: Individual Coaching Calls Participants will receive 3 30-minute online one-on-one coaching calls to focus on identifying and addressing challenges to successful behavior change and weight loss. Receives: Behavioral: Core; Behavioral: Counselor Crafted Feedback; Behavioral: Individual Coaching Calls |
| Core+ Counselor Crafted Feedback | Experimental | Behavioral: Core The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals.
Behavioral: Counselor Crafted Feedback Participants will receive up to 24 weekly messages that are crafted by a trained professional based on their dietary, physical activity, and weight monitoring for the week as well as their completion of online modules, to construct an individualized feedback message. Receives: Behavioral: Core; Behavioral: Counselor Crafted Feedback |
| Core+Pre-Scripted Feedback+Individual Coaching Calls | Experimental | Behavioral: Core The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals.
Behavioral: Pre-Scripted Feedback Participants will receive up to 24 weekly messages constructed from a bank of pre-scripted messages that align with success, partial success, or absence of self-monitoring related to diet monitoring, physical activity, and self-weighing, as well as on weekly module engagement.
Behavioral: Individual Coaching Calls Participants will receive 3 30-minute online one-on-one coaching calls to focus on identifying and addressing challenges to successful behavior change and weight loss. Receives: Behavioral: Core; Behavioral: Individual Coaching Calls; Behavioral: Pre-Scripted Feedback |
| Core+Pre-Scripted Feedback | Experimental | Behavioral: Core The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals.
Behavioral: Pre-Scripted Feedback Participants will receive up to 24 weekly messages constructed from a bank of pre-scripted messages that align with success, partial success, or absence of self-monitoring related to diet monitoring, physical activity, and self-weighing, as well as on weekly module engagement. Receives: Behavioral: Core; Behavioral: Pre-Scripted Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight at 6 months
The difference in weight between the randomization weight and the 6 month weight. Weight values will be obtained by an electronic scale provided to participants which transmits the data to the study server.
Measured: 6 months
Secondary outcomes (1)
Change in weight at 12 months
The difference in weight between the randomization weight and the 12 month weight. Weight values will be obtained by an electronic scale provided to participants which transmits the data to the study server.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start3 Jan 2024
- Primary completion28 Oct 2026
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 616 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- University of Virginia, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Delia Smith West, University of South Carolina
- Investigators
- Delia West, PhD, Principal investigator, University of South CarolinaRebecca Krukowski, PhD, Principal investigator, University of Virginia School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105957
- Sponsor's protocol ID
- Pro00123003
- Other IDs
- 1R01DK135227-01
- Acronym
- iREACH
- Status last verified
- Nov 2026
- First submitted
- 2 Oct 2023
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the first article reporting the primary outcomes and the first paper reporting the secondary outcomes will be shared after deidentification (text, tables, figures and appendices). Study protocol, informed consent form, statistical analysis plan and analytic code will be also available to be shared. The data will be made available 12 months after the publication of the article that reported the data. Data will be made available at the following website: https://dataverse.lib.virginia.edu/.
Publications
Chhabria K, Ross KM, Sacco SJ, Leahey TM. The Assessment of Supportive Accountability in Adults Seeking Obesity Treatment: Psychometric Validation Study. J Med Internet Res. 2020 Jul 28;22(7):e17967. doi: 10.2196/17967.
PubMed 32720911Kiernan M, Moore SD, Schoffman DE, Lee K, King AC, Taylor CB, Kiernan NE, Perri MG. Social support for healthy behaviors: scale psychometrics and prediction of weight loss among women in a behavioral program. Obesity (Silver Spring). 2012 Apr;20(4):756-64. doi: 10.1038/oby.2011.293. Epub 2011 Oct 13.
PubMed 21996661Kliemann N, Beeken RJ, Wardle J, Johnson F. Development and validation of the Self-Regulation of Eating Behaviour Questionnaire for adults. Int J Behav Nutr Phys Act. 2016 Aug 2;13:87. doi: 10.1186/s12966-016-0414-6.
PubMed 27484457Mohr DC, Cuijpers P, Lehman K. Supportive accountability: a model for providing human support to enhance adherence to eHealth interventions. J Med Internet Res. 2011 Mar 10;13(1):e30. doi: 10.2196/jmir.1602.
PubMed 21393123Nezu AM, Nezu CM, Perri MG. Problem-solving therapy for depression: Theory, research and clinical guidelines. John Wiley & Sons, 1989.
Procidano ME, Heller K. Measures of perceived social support from friends and from family: three validation studies. Am J Community Psychol. 1983 Feb;11(1):1-24. doi: 10.1007/BF00898416.
PubMed 6837532Williams GC, Grow VM, Freedman ZR, Ryan RM, Deci EL. Motivational predictors of weight loss and weight-loss maintenance. J Pers Soc Psychol. 1996 Jan;70(1):115-26. doi: 10.1037//0022-3514.70.1.115.
PubMed 8558405
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Rural Health Disparities by Optimizing "High Touch" Intervention Components in Digital Obesity Treatment
- ClinicalTrials.gov ID
- NCT06105957
- Acronym / sponsor ID
- iREACH / Pro00123003
- Conditions
- Overweight and Obesity
- Keywords
- behavioral weight control, weight management, online weight loss program
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 616 participants (estimated)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- University of Virginia, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 28 Oct 2026 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Over 130 million adults in the US experience overweight and obesity, and rural communities experience significantly higher rates of obesity and related chronic diseases. Although lifestyle interventions successfully produce clinically significant weight losses, the availability of weight management programs is limited in rural areas. Digital interventions offer an attractive alternative for delivering lifestyle programs to rural populations. However, in-person behavioral obesity treatment programs achieve better weight losses than digital programs, likely because in-person programs typically include personnel-intensive "high touch" treatment components. Some studies indicate that having a human "behind the curtain" of a digital program through emailed feedback or with the addition of online group sessions can significantly increase weight loss. Therefore, the aims of this study are to increase the public health impact of digital obesity treatment for rural populations by simultaneously investigating 3 "high touch" intervention components. The investigators will conduct a highly efficient experiment with participants residing in non-urban areas recruited online from across the United States. Participants (N=616; 22% racial/ethnic minority; 40% male) will be randomized to: (1) weekly facilitated synchronous group video sessions (yes vs. no); (2) type of self-monitoring feedback received (counselor-crafted vs. pre-scripted); and (3) individual coaching calls (yes vs. no). These components will be layered onto our 24-week evidence-based, interactive digital weight loss program delivered to groups of eligible individuals. Based on the results of the experiment, The investigators will identify an optimized program in which each component (or combination of components) contributes meaningfully (at least 1.5 kg greater weight loss at 6-months) to enhanced weight loss. The investigators will also exploratory analyses of weight trajectories 6-months post-treatment (i.e., at 12-months) to elucidate extended impact of the specific components on weight control. Ultimately, this research will set the stage for confirming the most promising digital behavioral weight loss intervention that can be used without geographic borders to reduce obesity rates among rural residents and provide the evidence needed to establish best practice policies for broadly effective digital approaches to weight control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Core+Facilitated Weekly Group Sessions+Counselor Crafted Feedback+Individual Coaching Calls | Experimental | Behavioral: Core, Behavioral: Facilitated Weekly Group Sessions, Behavioral: Counselor Crafted Feedback, Behavioral: Individual Coaching CallsBehavioral: Core The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals. Behavioral: Facilitated Weekly Group Sessions Participants will receive 24, 60-minute facilitated online video-conference-based weekly group sessions. Behavioral: Counselor Crafted Feedback Participants will receive up to 24 weekly messages that are crafted by a trained professional based on their dietary, physical activity, and weight monitoring for the week as well as their completion of online modules, to construct an individualized feedback message. Behavioral: Individual Coaching Calls Participants will receive 3 30-minute online one-on-one coaching calls to focus on identifying and addressing challenges to successful behavior change and weight loss. |
| Core+Facilitated Weekly Group Sessions+Pre-Scripted Feedback | Experimental | Behavioral: Core, Behavioral: Facilitated Weekly Group Sessions, Behavioral: Pre-Scripted FeedbackBehavioral: Core The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals. Behavioral: Facilitated Weekly Group Sessions Participants will receive 24, 60-minute facilitated online video-conference-based weekly group sessions. Behavioral: Pre-Scripted Feedback Participants will receive up to 24 weekly messages constructed from a bank of pre-scripted messages that align with success, partial success, or absence of self-monitoring related to diet monitoring, physical activity, and self-weighing, as well as on weekly module engagement. |
| Core+Facilitated Weekly Group Sessions+Pre-Scripted Feedback+Individual Coaching Calls | Experimental | Behavioral: Core, Behavioral: Facilitated Weekly Group Sessions, Behavioral: Individual Coaching Calls, Behavioral: Pre-Scripted FeedbackBehavioral: Core The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals. Behavioral: Facilitated Weekly Group Sessions Participants will receive 24, 60-minute facilitated online video-conference-based weekly group sessions. Behavioral: Pre-Scripted Feedback Participants will receive up to 24 weekly messages constructed from a bank of pre-scripted messages that align with success, partial success, or absence of self-monitoring related to diet monitoring, physical activity, and self-weighing, as well as on weekly module engagement. Behavioral: Individual Coaching Calls Participants will receive 3 30-minute online one-on-one coaching calls to focus on identifying and addressing challenges to successful behavior change and weight loss. |
| Core+Facilitated Weekly Group Sessions+Counselor Crafted Feedback | Experimental | Behavioral: Core, Behavioral: Facilitated Weekly Group Sessions, Behavioral: Counselor Crafted FeedbackBehavioral: Core The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals. Behavioral: Facilitated Weekly Group Sessions Participants will receive 24, 60-minute facilitated online video-conference-based weekly group sessions. Behavioral: Counselor Crafted Feedback Participants will receive up to 24 weekly messages that are crafted by a trained professional based on their dietary, physical activity, and weight monitoring for the week as well as their completion of online modules, to construct an individualized feedback message. |
| Core+ Counselor Crafted Feedback+Individual Coaching Calls | Experimental | Behavioral: Core, Behavioral: Counselor Crafted Feedback, Behavioral: Individual Coaching CallsBehavioral: Core The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals. Behavioral: Counselor Crafted Feedback Participants will receive up to 24 weekly messages that are crafted by a trained professional based on their dietary, physical activity, and weight monitoring for the week as well as their completion of online modules, to construct an individualized feedback message. Behavioral: Individual Coaching Calls Participants will receive 3 30-minute online one-on-one coaching calls to focus on identifying and addressing challenges to successful behavior change and weight loss. |
| Core+ Counselor Crafted Feedback | Experimental | Behavioral: Core, Behavioral: Counselor Crafted FeedbackBehavioral: Core The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals. Behavioral: Counselor Crafted Feedback Participants will receive up to 24 weekly messages that are crafted by a trained professional based on their dietary, physical activity, and weight monitoring for the week as well as their completion of online modules, to construct an individualized feedback message. |
| Core+Pre-Scripted Feedback+Individual Coaching Calls | Experimental | Behavioral: Core, Behavioral: Individual Coaching Calls, Behavioral: Pre-Scripted FeedbackBehavioral: Core The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals. Behavioral: Pre-Scripted Feedback Participants will receive up to 24 weekly messages constructed from a bank of pre-scripted messages that align with success, partial success, or absence of self-monitoring related to diet monitoring, physical activity, and self-weighing, as well as on weekly module engagement. Behavioral: Individual Coaching Calls Participants will receive 3 30-minute online one-on-one coaching calls to focus on identifying and addressing challenges to successful behavior change and weight loss. |
| Core+Pre-Scripted Feedback | Experimental | Behavioral: Core, Behavioral: Pre-Scripted FeedbackBehavioral: Core The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals. Behavioral: Pre-Scripted Feedback Participants will receive up to 24 weekly messages constructed from a bank of pre-scripted messages that align with success, partial success, or absence of self-monitoring related to diet monitoring, physical activity, and self-weighing, as well as on weekly module engagement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- have a body mass index [BMI] > 25-55 kg/m2;
Key exclusion criteria (5 listed)
- only one member of a household may participate concurrently.
- currently participating in another weight loss program, taking a weight loss medication, have a history of bariatric surgery, or lost ≥ 10 pounds during the past 6-months;
- are pregnant, lactating, less than 6 months post-partum, or plan to become pregnant during the time frame of the investigation;
- report a medical condition that would affect the safety and/or efficacy of a weight management program involving diet and physical activity (e.g., uncontrolled heart condition, dementia, bulimia nervosa or binge eating disorder, or other significant psychiatric problems);
- or report conditions that in the judgment of the one of the Principal Investigators (MPIs) would render them unlikely to be able to independently follow the intervention protocol for 6 months, including conditions which might comprise their ability to engage independently with the intervention website materials, provide self-monitoring information on a smartphone app, attend Zoom video group or individual sessions at the available times (if randomized to receive these treatment components), and complete online questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoreThe core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals. Weekly tips and discussion board postings invite participants to apply skills introduced in the modules and prompt interaction and social support within the closed group which starts the program simultaneously. | Behavioural | Core+ Counselor Crafted Feedback, Core+ Counselor Crafted Feedback+Individual Coaching Calls, Core+Facilitated Weekly Group Sessions+Counselor Crafted Feedback, Core+Facilitated Weekly Group Sessions+Counselor Crafted Feedback+Individual Coaching Calls, Core+Facilitated Weekly Group Sessions+Pre-Scripted Feedback, Core+Facilitated Weekly Group Sessions+Pre-Scripted Feedback+Individual Coaching Calls, Core+Pre-Scripted Feedback, Core+Pre-Scripted Feedback+Individual Coaching Calls |
| Facilitated Weekly Group SessionsParticipants will receive 24 facilitated online video-conference-based weekly group sessions. These groups will be 60 minutes long and will be facilitated by a trained professional, who reinforces the information and behavioral strategies introduced in the weekly modules, elicits the experiences of participants in applying behavioral skills to establish new diet and exercise habits, and guides problem solving. Group cohesion to offer social support is promoted. | Behavioural | Core+Facilitated Weekly Group Sessions+Counselor Crafted Feedback, Core+Facilitated Weekly Group Sessions+Counselor Crafted Feedback+Individual Coaching Calls, Core+Facilitated Weekly Group Sessions+Pre-Scripted Feedback, Core+Facilitated Weekly Group Sessions+Pre-Scripted Feedback+Individual Coaching Calls |
| Counselor Crafted FeedbackParticipants will receive up to 24 weekly messages that are crafted by a trained professional based on their dietary, physical activity, and weight monitoring for the week as well as their completion of online modules, to construct an individualized feedback message. The emailed feedback will provide positive reinforcement for successful goal achievement, identify possible areas for improvement, and suggest possible strategies for identified challenges. | Behavioural | Core+ Counselor Crafted Feedback, Core+ Counselor Crafted Feedback+Individual Coaching Calls, Core+Facilitated Weekly Group Sessions+Counselor Crafted Feedback, Core+Facilitated Weekly Group Sessions+Counselor Crafted Feedback+Individual Coaching Calls |
| Individual Coaching CallsParticipants will receive 3 online one-on-one coaching calls to focus on identifying and addressing challenges to successful behavior change and weight loss. The first call will emphasize amplifying motivation and promoting early treatment engagement by establishing rapport, exploring personal reasons for weight loss and lifestyle change, and reinforcing and expanding change talk, and it will occur prior to starting the core program. Subsequent calls will use a motivational interviewing-informed approach to problem solve barriers to self-monitoring, particularly dietary self-monitoring because of the strong role it plays in promoting better weight loss and will occur during the first half of the program, reflecting the critical role of early engagement in the treatment program on long term weight loss success. Coaching calls will be of approximately 30 min duration and will follow a semi-structured interview format. | Behavioural | Core+ Counselor Crafted Feedback+Individual Coaching Calls, Core+Facilitated Weekly Group Sessions+Counselor Crafted Feedback+Individual Coaching Calls, Core+Facilitated Weekly Group Sessions+Pre-Scripted Feedback+Individual Coaching Calls, Core+Pre-Scripted Feedback+Individual Coaching Calls |
| Pre-Scripted FeedbackParticipants will receive up to 24 weekly messages constructed from a bank of pre-scripted messages that align with success, partial success, or absence of self-monitoring within each of the following domains: dietary monitoring, physical activity monitoring, and self-weighing, as well as on weekly module completion. Feedback is automatically generated based on decision algorithms and will be sent from program staff. | Behavioural | Core+Facilitated Weekly Group Sessions+Pre-Scripted Feedback, Core+Facilitated Weekly Group Sessions+Pre-Scripted Feedback+Individual Coaching Calls, Core+Pre-Scripted Feedback, Core+Pre-Scripted Feedback+Individual Coaching Calls |
Primary outcome
Change in weight at 6 months
Time frame: 6 months
The difference in weight between the randomization weight and the 6 month weight. Weight values will be obtained by an electronic scale provided to participants which transmits the data to the study server.
1 secondary outcome
Change in weight at 12 months
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Background: PubMed 32720911Chhabria K, Ross KM, Sacco SJ, Leahey TM. The Assessment of Supportive Accountability in Adults Seeking Obesity Treatment: Psychometric Validation Study. J Med Internet Res. 2020 Jul 28;22(7):e17967. doi: 10.2196/17967.
- Background: PubMed 21996661Kiernan M, Moore SD, Schoffman DE, Lee K, King AC, Taylor CB, Kiernan NE, Perri MG. Social support for healthy behaviors: scale psychometrics and prediction of weight loss among women in a behavioral program. Obesity (Silver Spring). 2012 Apr;20(4):756-64. doi: 10.1038/oby.2011.293. Epub 2011 Oct 13.
- Background: PubMed 27484457Kliemann N, Beeken RJ, Wardle J, Johnson F. Development and validation of the Self-Regulation of Eating Behaviour Questionnaire for adults. Int J Behav Nutr Phys Act. 2016 Aug 2;13:87. doi: 10.1186/s12966-016-0414-6.
- Background: PubMed 21393123Mohr DC, Cuijpers P, Lehman K. Supportive accountability: a model for providing human support to enhance adherence to eHealth interventions. J Med Internet Res. 2011 Mar 10;13(1):e30. doi: 10.2196/jmir.1602.
- BackgroundNezu AM, Nezu CM, Perri MG. Problem-solving therapy for depression: Theory, research and clinical guidelines. John Wiley & Sons, 1989.
- Background: PubMed 6837532Procidano ME, Heller K. Measures of perceived social support from friends and from family: three validation studies. Am J Community Psychol. 1983 Feb;11(1):1-24. doi: 10.1007/BF00898416.
- Background: PubMed 8558405Williams GC, Grow VM, Freedman ZR, Ryan RM, Deci EL. Motivational predictors of weight loss and weight-loss maintenance. J Pers Soc Psychol. 1996 Jan;70(1):115-26. doi: 10.1037//0022-3514.70.1.115.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the first article reporting the primary outcomes and the first paper reporting the secondary outcomes will be shared after deidentification (text, tables, figures and appendices). Study protocol, informed consent form, statistical analysis plan and analytic code will be also available to be shared. The data will be made available 12 months after the publication of the article that reported the data. Data will be made available at the following website: https://dataverse.lib.virginia.edu/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Delia West, PhD principal investigator
University of South Carolina
Rebecca Krukowski, PhD principal investigator
University of Virginia School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core, Facilitated Weekly Group Sessions and Counselor Crafted Feedback in people with Overweight and Obesity, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06105957, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.