Digital Weight Loss Interventions for Obesity

(iREACH Trial)

Overseen By Janna Borden, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of South Carolina

Must not be taking: Weight loss medications

Disqualifiers: Pregnancy, Bariatric surgery, Heart condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 24

Duration: 24 weeks

616 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications, but you cannot participate if you are currently taking a weight loss medication.

What data supports the effectiveness of the treatment Optimal Digital Weight Loss Treatment for Rural Individuals?

Research shows that digital weight loss programs, including web-based and mobile health interventions, can lead to significant weight loss in rural populations. Studies have found that these interventions are effective in achieving clinically meaningful weight loss, with longer programs resulting in greater weight reduction. ^{1 2 3 4 5}

Is the digital weight loss intervention safe for humans?

The research articles do not provide specific safety data for digital weight loss interventions, but they focus on the effectiveness and feasibility of these interventions in rural populations. ^{2 3 4 6 7}

How is the Optimal Digital Weight Loss Treatment for Rural Individuals different from other treatments for obesity?

This treatment is unique because it uses digital tools like mobile apps and web-based platforms to support weight loss, specifically targeting rural populations who may have limited access to traditional healthcare services. It emphasizes user engagement with technology and personalized support, such as virtual sessions with dietitians, to achieve meaningful weight loss. ^{2 3 8 9 10}

What is the purpose of this trial?

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.

Research Team

Delia West, PhD

Principal Investigator

University of South Carolina

Rebecca Krukowski, PhD

Principal Investigator

University of Virginia School of Medicine

Eligibility Criteria

This trial is for adults living in non-urban US areas with a BMI of 25-55, who can walk moderately for at least 10 minutes. They must have internet access and not be in another weight loss program or have had significant weight changes recently. Pregnant individuals or those with certain medical conditions are excluded.

Inclusion Criteria

You have a body mass index (BMI) that is higher than the normal range, which is between 25 and 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

I can walk at a moderate pace for 10 minutes without stopping.

Exclusion Criteria

I am not in a weight loss program, taking weight loss drugs, had bariatric surgery, or lost 10+ pounds recently.

I can follow the study's protocol and use its digital tools for 6 months.

I do not have any health issues that would make a diet and exercise program unsafe for me.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 24-week digital weight loss program with various 'high touch' components such as weekly group sessions, self-monitoring feedback, and individual coaching calls.

24 weeks

24 online weekly sessions

Follow-up

Participants are monitored for weight trajectories and the extended impact of the intervention components on weight control.

6 months

Treatment Details

Interventions

• Optimal Digital Weight Loss Treatment for Rural Individuals

Trial Overview The study tests if 'high touch' digital components like group video sessions, personalized feedback, and coaching calls improve weight loss in rural populations. Participants will use an interactive digital program over 24 weeks to see which methods contribute most to weight control.

Participant Groups

Group I: Core+Pre-Scripted Feedback+Individual Coaching Calls Experimental Treatment 3 Interventions

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.

Group II: Core+Pre-Scripted Feedback Experimental Treatment 2 Interventions

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.

Group III: Core+Facilitated Weekly Group Sessions+Pre-Scripted Feedback+Individual Coaching Calls Experimental Treatment 4 Interventions

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.

Group IV: Core+Facilitated Weekly Group Sessions+Pre-Scripted Feedback Experimental Treatment 3 Interventions

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.

Group V: Core+Facilitated Weekly Group Sessions+Counselor Crafted Feedback+Individual Coaching Calls Experimental Treatment 4 Interventions

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.

Group VI: Core+Facilitated Weekly Group Sessions+Counselor Crafted Feedback Experimental Treatment 3 Interventions

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.

Group VII: Core+ Counselor Crafted Feedback+Individual Coaching Calls Experimental Treatment 3 Interventions

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.

Group VIII: Core+ Counselor Crafted Feedback Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

University of South Carolina

Lead Sponsor

Trials

233

Recruited

122,000+

University of Virginia

Collaborator

Trials

802

Recruited

1,342,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

University of Vermont

Collaborator

Trials

283

Recruited

3,747,000+

Findings from Research

A telemedicine weight management program called Wellness Connect was implemented in rural South Carolina, where 138 patients participated, and 62% completed the program, demonstrating its feasibility in areas with limited access to obesity treatment.

Patients who completed the program lost an average of 3.5% of their body weight, which is statistically significant, indicating that telemedicine can effectively support weight loss in rural populations despite challenges in sustainability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Description, utilisation and results from a telehealth primary care weight management intervention for adults with obesity in South Carolina. Brown, JD., Hales, S., Evans, TE., et al.[2020]

High engagement with messaging features in a web-based weight loss intervention significantly predicted achieving at least 5% body weight loss after both 6 and 18 months among 201 rural women at risk for obesity-related diseases.

Self-tracking features did not show a significant effect on weight loss outcomes, highlighting the importance of interactive messaging in promoting behavior change for weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User Engagement Associated with Web-Intervention Features to Attain Clinically Meaningful Weight Loss and Weight Maintenance in Rural Women. Hageman, PA., Mroz, JE., Yoerger, MA., et al.[2020]

A pilot study involving 80 overweight and obese men aged 40-69 showed that an enhanced mobile app (MT+) led to greater weight loss (7.03 kg) compared to a basic app (MT) which resulted in 4.14 kg weight loss over 6 months, indicating that additional support features can improve outcomes.

The study demonstrated high acceptability and adherence rates to self-monitoring behaviors, with over 90% of participants finding the app and smart scale acceptable, and significant engagement in tracking dietary intake and physical activity, suggesting that mobile technology can effectively support weight loss in rural populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile health assisted self-monitoring is acceptable for supporting weight loss in rural men: a pragmatic randomized controlled feasibility trial. Eisenhauer, CM., Brito, F., Kupzyk, K., et al.[2022]

A systematic review of 64 articles on rural weight loss interventions found that these programs can lead to significant weight loss, with a median reduction of 3.64 kg per participant, especially in longer-duration interventions.

Despite their effectiveness, the reach and cost-effectiveness of these interventions remain unclear, as only a few studies reported on participant representativeness and actual delivery settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding the impact of rural weight loss interventions: A systematic review and meta-analysis. Porter, GC., Laumb, K., Michaud, T., et al.[2020]

The yearlong digital weight-loss intervention in a rural community did not result in significant weight loss or health score improvements among the 67 participants, primarily women in their mid-40s.

Despite the lack of clinical weight loss, a moderate negative correlation was found between weight and health scores, suggesting that as participants adopted healthier behaviors, their weight tended to decrease, indicating potential benefits of lifestyle changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A quasi-experimental study on adult weight loss using a multidimensional approach among a rural population. Burrell, C.[2023]

A pilot trial involving 34 rural women showed that a 6-month behavioral weight loss program delivered via group phone calls resulted in greater weight loss (mean 14.9 kg) compared to individual phone counseling (mean 9.5 kg), indicating that group support may enhance treatment efficacy.

The group phone-based treatment was not only more effective, with 62% of participants achieving a 10% weight loss goal compared to 50% in the individual condition, but it was also found to be more cost-effective, suggesting a promising strategy for obesity management in rural areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group versus individual phone-based obesity treatment for rural women. Befort, CA., Donnelly, JE., Sullivan, DK., et al.[2021]

This pilot trial involves 80 overweight or obese rural men aged 40-69 and aims to assess the feasibility and acceptability of two mobile applications for weight loss over a 6-month period.

The study will compare a more comprehensive intervention (MT+) that includes a self-monitoring app, discussion group, text support, and Wi-Fi scale against a basic app (MT), to evaluate their effectiveness in promoting weight loss and improving dietary and physical activity behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile technology intervention for weight loss in rural men: protocol for a pilot pragmatic randomised controlled trial. Eisenhauer, CM., Brito, FA., Yoder, AM., et al.[2023]

The study tested the feasibility of an online nutrition tracking app, Good Measures, with 64 patients in West Virginia, showing that while there were minimal improvements in weight and blood pressure, participants generally had a positive experience with the app and access to Registered Dietitian Nutritionists (RDNs).

Despite some declines in participant attitudes over the 12-week study, rural clinic patients reported less negative change compared to those in peri-urban areas, suggesting that the app could be a valuable tool for addressing obesity in rural populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a mHealth Approach to Nutrition Counseling in an Appalachian State. Olfert, MD., Barr, ML., Hagedorn, RL., et al.[2020]

The SMART intervention, which utilized social and mobile technologies for weight loss, showed significant short-term weight loss at 6 and 12 months among young adults, but did not maintain this effect at 24 months, indicating limited long-term efficacy.

While the intervention was generally safe, there was one serious adverse event (gallstones) linked to rapid weight loss, highlighting the need for careful monitoring in weight loss programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using social and mobile tools for weight loss in overweight and obese young adults (Project SMART): a 2 year, parallel-group, randomised, controlled trial. Godino, JG., Merchant, G., Norman, GJ., et al.[2022]

In a study of 492 adults participating in an online behavioral weight control intervention, both rural and urban residents achieved similar weight loss outcomes after 6 months, losing an average of -6.1 kg and -5.3 kg respectively, indicating that location did not significantly impact weight loss effectiveness.

There were no notable differences in adherence to treatment goals, such as attendance in online chats or self-monitoring of diet and physical activity, suggesting that both groups engaged similarly in the weight control program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight Loss Success of Participants Residing in Rural and Urban Areas. Mench, E., West, D., Krukowski, R., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Description, utilisation and results from a telehealth primary care weight management intervention for adults with obesity in South Carolina. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

User Engagement Associated with Web-Intervention Features to Attain Clinically Meaningful Weight Loss and Weight Maintenance in Rural Women. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Mobile health assisted self-monitoring is acceptable for supporting weight loss in rural men: a pragmatic randomized controlled feasibility trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Understanding the impact of rural weight loss interventions: A systematic review and meta-analysis. [2020]

5. England pubmed.ncbi.nlm.nih.gov

A quasi-experimental study on adult weight loss using a multidimensional approach among a rural population. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Group versus individual phone-based obesity treatment for rural women. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Mobile technology intervention for weight loss in rural men: protocol for a pilot pragmatic randomised controlled trial. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility of a mHealth Approach to Nutrition Counseling in an Appalachian State. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Using social and mobile tools for weight loss in overweight and obese young adults (Project SMART): a 2 year, parallel-group, randomised, controlled trial. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Weight Loss Success of Participants Residing in Rural and Urban Areas. [2019]