Mobile Weight Loss Program for Obesity

Overseen By Brooke T Nezami, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: UNC Lineberger Comprehensive Cancer Center

Must not be taking: Oral steroids, Weight loss medications

Disqualifiers: Eating disorders, Pregnancy, Psychiatric disorders, Heart conditions, Cancer, others

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve weight loss by testing various strategies added to a mobile program, including simplified diet tracking, personalized text messages, health coaching, and goal-setting tools. The researchers seek to identify the best combination of these methods to help individuals adhere to their diet plans. Individuals with a BMI between 25 and 50, who own a smartphone and are open to trying different methods, may be suitable for this trial. As an unphased trial, participants can explore innovative weight loss strategies and contribute to valuable research.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are using prescription medications that affect appetite or weight, you may not be eligible unless you have been on a stable dose of SSRIs for 3 months. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that mobile apps and digital tools are generally safe for weight management programs. For example, studies have found that using mobile apps to track diet and weight is well-received, with participants often finding these tools helpful for monitoring progress.

One study found that digital tools are low-risk and beneficial as additional support for regular weight management efforts. Users reported few, if any, negative effects from these apps. The goal is to help people adhere to their dietary goals in a more engaging and personalized way.

The treatments in this trial enhance a standard mobile weight loss program, building on methods already known to be safe and effective. While these improvements are new, they resemble existing digital tools proven safe in previous research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this mobile weight loss program because it focuses on optimizing dietary adherence through technology and personalized support. Unlike traditional methods that primarily rely on in-person consultations, this program leverages mobile technology for simplified diet monitoring, providing real-time feedback and just-in-time messaging. It also emphasizes goal autonomy and planning, empowering participants to take control of their weight loss journey. Additionally, the inclusion of coach sessions offers personalized guidance, making it a comprehensive approach that adapts to individual needs. This innovative combination of technology and personalized support could potentially enhance adherence and effectiveness compared to standard weight loss programs.

What evidence suggests that this trial's treatments could be effective for obesity?

Studies have shown that mobile apps can aid in weight loss. Research indicates that tracking food intake with these apps can lead to weight reduction, with one study noting an average decrease of 1.92 BMI points over three months. This trial will explore various approaches within a mobile weight loss program, including different combinations of simplified diet monitoring, goal autonomy/planning, just-in-time messaging, and coaching sessions. Increased involvement with digital therapy appears to enhance weight loss outcomes. Additionally, strategies like personalized text messages and coaching sessions have helped individuals adhere to their diet plans. Overall, mobile health tools support adherence to dietary goals and promote weight loss. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults who want to lose weight and are willing to use a mobile app as part of a 6-month behavioral weight loss program. Participants should be able to follow dietary recommendations and track their eating habits using digital tools.

Inclusion Criteria

English-speaking and writing

I am willing to be randomly assigned to any treatment group in the study.

BMI 25-50 kg/m2 at baseline

Exclusion Criteria

Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q; items 1-4)

Another member of the household is a participant or staff member on this trial

I am able to understand and agree to participate in this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Core Program

Participants receive a 6-month standard mobile behavioral weight loss program with evidence-based behavior change strategies, including self-monitoring and adherence to dietary and activity goals.

6 months

Baseline, 4 weeks (online), 8 weeks (online), 3 months, 6 months

Factorial Trial (Nonresponders)

Participants with low adherence are randomized to additional treatment components to optimize dietary adherence.

Remainder of 6 months

Follow-up

Participants are monitored for dietary adherence and weight loss outcomes.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Optimization of Dietary Adherence in a Mobile Weight Loss Intervention

Trial Overview

The study tests different ways to help people stick with diet goals in a mobile weight loss program, including health coach sessions, simplified food tracking, personalized text reminders, and goal planning tools. The aim is to find the best mix of these supports.

How Is the Trial Designed?

Group I: Core Only (Responders) Experimental Treatment 1 Intervention

Core program (participants who are not randomized in the factorial intervention)

Group II: Condition 9 Experimental Treatment 4 Interventions

Core with Standard Diet Monitoring + Goal Autonomy/Planning + Just-in-time (JIT) Messaging + Coach Sessions

Group III: Condition 8 Experimental Treatment 2 Interventions

Core + Switch to Simplified Diet Monitoring

Group IV: Condition 7 Experimental Treatment 3 Interventions

Core + Switch to Simplified Diet Monitoring + Coach Sessions

Group V: Condition 6 Experimental Treatment 3 Interventions

Core + Switch to Simplified Diet Monitoring + Just-in-time (JIT) Messaging

Group VI: Condition 5 Experimental Treatment 4 Interventions

Core + Switch to Simplified Diet Monitoring + Just-in-time (JIT) Messaging + Coach Sessions

Group VII: Condition 4 Experimental Treatment 3 Interventions

Core + Switch to Simplified Diet Monitoring + Goal Autonomy/Planning

Group VIII: Condition 3 Experimental Treatment 4 Interventions

Core + Switch to Simplified Diet Monitoring + Goal Autonomy/Planning + Coach Sessions

Group IX: Condition 2 Experimental Treatment 4 Interventions

Core + Switch to Simplified Diet Monitoring + Goal Autonomy/Planning + Just-in-time (JIT) Messaging

Group X: Condition 16 Experimental Treatment 1 Intervention

Core with Standard Diet Monitoring

Group XI: Condition 15 Experimental Treatment 2 Interventions

Core with Standard Diet Monitoring + Coach Sessions

Group XII: Condition 14 Experimental Treatment 2 Interventions

Core with Standard Diet Monitoring + Just-in-time (JIT) Messaging

Group XIII: Condition 13 Experimental Treatment 3 Interventions

Core with Standard Diet Monitoring + Just-in-time (JIT) Messaging + Coach Sessions

Group XIV: Condition 12 Experimental Treatment 2 Interventions

Core with Standard Diet Monitoring + Goal Autonomy/Planning

Group XV: Condition 11 Experimental Treatment 3 Interventions

Core with Standard Diet Monitoring + Goal Autonomy/Planning + Coach Sessions

Group XVI: Condition 10 Experimental Treatment 3 Interventions

Core with Standard Diet Monitoring + Goal Autonomy/Planning + Just-in-time (JIT) Messaging

Group XVII: Condition 1 Experimental Treatment 5 Interventions

Core + Switch to Simplified Diet Monitoring + Goal Autonomy/Planning + Just-in-time (JIT) Messaging + Coach Sessions

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07582536

Optimization of Dietary Adherence in a Mobile Weight Loss ...

The goal of this study is to test multiple individual treatment components added to a 6-month standard mobile behavioral weight loss program ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9159560/

Adherence to mobile‐app‐based dietary self‐monitoring ...

Results of the current study suggest that completely self‐monitoring ≥50% of an individualized weekly calorie goal may not help with short‐term weight loss.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12782785/

Effectiveness of a mobile health intervention on weight loss ...

This study aimed to determine whether a mobile health (mhealth) intervention is effective in reducing weight and changing dietary behavior among employees ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1871403X16300291

Adherence as a predictor of weight loss in a commonly ...

An average 1.92 BMI points were lost after using Noom for three months, and for every 10% increase in adherence there was a decrease of 2.59 BMI points (β = − ...

5.

jmir.org

jmir.org/2025/1/e72054

Effectiveness of a Digital Therapy on 6-Month Weight Loss ...

These results suggest that higher engagement with DTx can improve obesity outcomes. Further research should explore combining DTxO with ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12504904/

Optimizing Self-Monitoring in a Digital Weight Loss ... - PMC

Self-monitoring is a vital component of behavioral obesity treatment. It often involves tracking dietary intake, physical activity, and body weight.

7.

researchprotocols.org

researchprotocols.org/2025/1/e75629

Optimizing Self-Monitoring in a Digital Weight Loss ...

Secondary outcomes include change in BMI, caloric intake, diet quality, physical activity, and health-related quality of life, as well as 1- and ...

8.

jmir.org

jmir.org/2013/4/e32/

Adherence to a Smartphone Application for Weight Loss ...

The aim of this pilot study was to collect acceptability and feasibility outcomes of a self-monitoring weight management intervention delivered by a smartphone ...