- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06105957
Optimal Digital Weight Loss Treatment for Rural Individuals (iREACH)
Addressing Rural Health Disparities by Optimizing "High Touch" Intervention Components in Digital Obesity Treatment
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Teace Markwalter, MPH, CHES
- Phone Number: 434-297-5874
- Email: bdw9cp@virginia.edu
Study Contact Backup
- Name: Janna Borden, MS
- Phone Number: 803-777-3471
- Email: jsborden@mailbox.sc.edu
Study Locations
-
-
South Carolina
-
Columbia, South Carolina, United States, 29208
- Recruiting
- University of South Carolina
-
Contact:
- Teace Markwalter, MPH, CHES
- Phone Number: 866-271-7217
- Email: bdw9cp@virginia.edu
-
Contact:
- Janna Borden, MS
- Phone Number: 866-271-7217
- Email: jsborden@mailbox.sc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
have a body mass index [BMI] > 25-55 kg/m2;
- home address in a zip code classified as non-urban in the USDA Rural-Urban Commuting Area [RUCA] codes of 4-10);
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Core+Facilitated Weekly Group Sessions+Counselor Crafted Feedback+Individual Coaching Calls
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. |
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.
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.
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.
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.
|
Experimental: Core+Facilitated Weekly Group Sessions+Pre-Scripted Feedback
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. |
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.
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.
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.
|
Experimental: Core+Facilitated Weekly Group Sessions+Pre-Scripted Feedback+Individual Coaching Calls
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. |
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.
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.
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.
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.
|
Experimental: Core+Facilitated Weekly Group Sessions+Counselor Crafted Feedback
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. |
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.
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.
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.
|
Experimental: Core+ Counselor Crafted Feedback+Individual Coaching Calls
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. |
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.
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.
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.
|
Experimental: Core+ Counselor Crafted Feedback
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. |
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.
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.
|
Experimental: Core+Pre-Scripted Feedback+Individual Coaching Calls
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. |
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.
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.
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.
|
Experimental: Core+Pre-Scripted Feedback
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. |
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in weight at 12 months
Time Frame: 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.
|
12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in weight at 2 months
Time Frame: 2 months
|
The difference in weight between the randomization weight and the 2 month data collection weight will be obtained by a Fitbit e-scale and transmitted to the study.server
|
2 months
|
Days of self-monitoring of body weight
Time Frame: Calculated continuously for 12 months
|
Body Weight self-monitoring will be objectively measured as the number of days on which data on weight were transmitted via the study provided e-scale to the study team via Fitbit API
|
Calculated continuously for 12 months
|
Days of dietary self-monitoring
Time Frame: Calculated continuously for 12 months
|
Dietary self-monitoring will be objectively measured as the number of days on which data on dietary intake (foods and beverages consumed) for a minimum of 2 meals were entered into the Fitbit app and transmitted to the study team via Fitbit API
|
Calculated continuously for 12 months
|
Days of physical activity self-monitoring
Time Frame: Calculated continuously for 12 months
|
physical activity self-monitoring will be objectively measured as the number of days on which activity data were collected by wearing the study-provided Fitbit tracker and were transmitted to the study team via Fitbit API; days with wear time of a minimum of >/= 10 hours, assessed as 10 hours of non-zero heart rate measurements captured by the Fitbit device, will be considered as a day of self monitoring
|
Calculated continuously for 12 months
|
Proportion of interactive, e-learning modules completed
Time Frame: Calculated continuously for 6 months
|
The proportion of modules presenting behavioral weight management skill building lessons which are completed by participants will be determined through website utilization data and proportion completed will be calculated as number of modules completed / 24 [i.e., the total number of modules made available over the course of the intervention]
|
Calculated continuously for 6 months
|
Proportion of Group Chat Sessions and Individual Coaching calls attended (percentage), for those who are randomized to receive these treatment elements
Time Frame: Calculated continuously for 6 months
|
Attendance at treatment sessions will be recorded by interventionist personnel delivering the sessions for those participants randomized to receive these treatment elements and the proportion attended will be calculated (attended /number offered).
|
Calculated continuously for 6 months
|
Self-regulation
Time Frame: administered at baseline, 6 and 12 months
|
Self-regulation is the general ability to regulate behavior to achieve desired future outcomes and personal goals through monitoring progress through self-monitoring, goal setting, getting feedback, making adjustments to behavior, and self-rewarding; utilization of weight management self regulation processes will be assessed using the Self-Regulation Questionnaire (Kliemann, Beeken, Wardle, 2016).
The measure has 63 items which are answered on a 5-point Likert scale (1-strongly disagree top 5= strong agree) and higher scores indicate a greater-self-regulation capacity.
|
administered at baseline, 6 and 12 months
|
Supportive Accountability
Time Frame: administered at 2 and 6 months
|
Supportive accountability may increase treatment adherence when a trustworthy and caring person with specific expertise is perceived to be monitoring one's actions, and individuals feel an obligation to deliver on a commitment or explain reasons for failing to achieve an outcome.
The investigators will assess supportive accountability using the Support Accountability Inventory (Meyerhoff, Haldar, & Mohr, 2021).
This inventory consists of 6 items with a Likert scale response format ranging from 1 (Strongly Disagree) to 7 (Strongly Agree), with higher total scores indicating higher perceived supportive accountability
|
administered at 2 and 6 months
|
Problem solving
Time Frame: administered at baseline and 6 months
|
Problem solving is a formal process to identify barriers and challenges to behavior change and constructively identify potential resolutions to minimize the negative impact of the barriers on behavior change; problem solving will be assessed by the Problem Solving Test (Nezu, Nezu & D'Zurilla, 2012)
|
administered at baseline and 6 months
|
Motivation
Time Frame: administered at baseline and 2, 6 and 12 months
|
Autonomous reasons for engaging in weight control efforts (personal reasons for change or motivations that reflect an internalized rationale for change) and controlled motivation reasons for behavior change and weight loss that are externally imposed or arise from others) will be assessed with the Treatment Self-Regulation Questionnaire (Williams et al, 1996).
The measure consists of 12 items, all scored using a 7-point Likert scale (1= not at all true to 7 = very true).
Higher scores on the Autonomous Subscale (6 items) indicate greater autonomous motivations for behavior change and higher scores on the Controlled Motivations subscale (6 items) indicate higher controlled regulation.
|
administered at baseline and 2, 6 and 12 months
|
Social Support for Weight Control Behaviors
Time Frame: administered at baseline and 2, 6 and 12 months
|
Social support can facilitate weight loss and a group based program such as this can offer social support, assessed by the Social Support for Healthy Behaviors Scale which queries about social support for and sabotage of weight control behaviors from family, friends, and group members.
Eighteen items assess support/sabotage for consuming a healthy dietary pattern over the previous month (the same 9 items rated separately for family members and for friends/group members using response options on a 4-point scale which ranges from almost never to almost always).
Responses are coded into a social support subscale and a sabotage subscale, with higher mean scores indicating more support or more sabotage, respectively.
An additional 18 items assess social support/sabotage for physical activity from family and friends using the same format (Ball & Crawford, 2006; Kiernan et al, 2012)
|
administered at baseline and 2, 6 and 12 months
|
Group Cohesion and Social Support
Time Frame: administered at 2 and 6 months
|
Perceived social support and group cohesion may differ based on whether individuals participate in synchronous face-to-face group sessions or if they have asynchronous, text-based communication to offer social support; therefore, we will assess group cohesion using the Group Cohesion Scale (Procidano &Heller 1983).
This measure has 20 items focused on perceptions of other group members which employ a yes/no answer format plus a rating of perceived support from group leader item which ranges from 1 to 10 (with 10 being extremely supportive and 1 being not at all supportive).
Higher total scores indicate greater perceived cohesion and social support from the group.
|
administered at 2 and 6 months
|
Cost
Time Frame: Calculated continuously for 6 months
|
The non-research related costs associated with delivery of each treatment component will be continuously monitored.
|
Calculated continuously for 6 months
|
Perceptions of Accountability
Time Frame: administered at 2 and 6 months
|
Perceived accountability will be assessed using the Perceptions of Accountability subscale of the Supportive Accountability Measure (Chhabria, Ross & Leahey, 2020).
This measure includes 10 items, using a 7-point Likert scale (1 = not at all to 7 i= very much).
The minimum score obtainable is 10 and the highest possible score is 70, and higher scores indicate greater perceived accountability.
|
administered at 2 and 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Delia West, PhD, University of South Carolina
- Principal Investigator: Rebecca Krukowski, PhD, University of Virginia School of Medicine
Publications and helpful links
General Publications
- Williams 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.
- Kliemann 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.
- 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.
- Mohr 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.
- 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.
- Kiernan 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.
- Nezu AM, Nezu CM, Perri MG. Problem-solving therapy for depression: Theory, research and clinical guidelines. John Wiley & Sons, 1989.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00123003
- 1R01DK135227-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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