Optimal Digital Weight Loss Treatment for Rural Individuals

Overweight and Obesity Clinical Trial

— iREACH  

Official title:

Addressing Rural Health Disparities by Optimizing "High Touch" Intervention Components in Digital Obesity Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06105957
• Other study ID #: Pro00123003
• Secondary ID: 1R01DK135227-01
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: May 2024
• Source: University of South Carolina
• Contact: Teace Markwalter, MPH, CHES
• Phone: 434-297-5874
• Email: bdw9cp[@]virginia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 616
• Est. completion date: December 31, 2027
• Est. primary completion date: February 28, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity

Intervention

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. 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 Sessions
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 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 emailed feedback will provide positive reinforcement for successful goal achievement, identify possible areas for improvement, and suggest possible strategies for identified challenges.
• Individual Coaching Calls
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 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 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.

Locations

Country	Name	City	State
United States	University of South Carolina	Columbia	South Carolina

Sponsors (4)

Lead Sponsor	Collaborator
University of South Carolina	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Vermont, University of Virginia

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Nezu 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in weight at 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
Other	Days of self-monitoring of body weight	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
Other	Days of dietary self-monitoring	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
Other	Days of physical activity self-monitoring	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
Other	Proportion of interactive, e-learning modules completed	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
Other	Proportion of Group Chat Sessions and Individual Coaching calls attended (percentage), for those who are randomized to receive these treatment elements	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
Other	Self-regulation	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
Other	Supportive Accountability	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
Other	Problem solving	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
Other	Motivation	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
Other	Social Support for Weight Control Behaviors	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
Other	Group Cohesion and Social Support	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
Other	Cost	The non-research related costs associated with delivery of each treatment component will be continuously monitored.	Calculated continuously for 6 months
Other	Perceptions of Accountability	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
Primary	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.	6 months
Secondary	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.	12 months