Digital Weight Loss Intervention for Obesity

(Nudge Trial)

Overseen By Karen E Hatley, MPH, RD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: Oral steroids, Weight loss medications

Disqualifiers: Diabetes, Heart condition, Cancer, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how various motivational messages can assist young adults with obesity in achieving daily weight-related goals through a smartphone app. The study tests seven behavior change messages, such as planning actions or seeking social support, by sending them at optimal moments to enhance motivation. Additionally, the trial includes a Core Behavioral Weight Loss (BWL) Intervention to aid in weight management. It is ideal for English-speaking individuals with a BMI between 25 and 45 who own a smartphone and seek a digital method for weight management. As an unphased trial, this study offers a unique opportunity to contribute to innovative research in digital health and weight management.

Do I have to stop taking my current medications for the trial?

You may need to stop taking certain medications that affect appetite or weight, like oral steroids or weight loss medications. However, if you're on a stable dose of SSRIs (a type of antidepressant) for at least 3 months, you can continue taking them.

What prior data suggests that this digital weight loss intervention is safe for young adults with obesity?

Research has shown that weight loss programs like those in this trial are generally easy for participants to follow. These programs often use tools such as activity trackers and apps to manage weight by setting goals and providing feedback. These tools are widely used and considered safe.

While specific safety data on the exact behavior change techniques (BCTs) being tested is limited, techniques like "Action Planning" and "Social Support" are common in many health programs. They aim to help people change their habits in supportive ways. Reviews of similar techniques suggest they are usually safe.

The trial is labeled as "Not Applicable" for its phase, indicating it likely involves low-risk activities. This suggests that the techniques are expected to be safe for participants. If concerns arise, discussing them with the trial organizers or a healthcare provider is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these digital weight loss interventions for obesity because they integrate personalized behavior change techniques with core behavioral weight loss strategies. Unlike standard options like diet plans, medications, or surgery, these interventions use a combination of technology and psychology to encourage sustainable lifestyle changes. They employ a smartphone app with features like activity tracking, tailored feedback, and social support, making it highly interactive and adaptable to individual needs. By focusing on past successes and providing social rewards, these interventions aim to boost motivation and adherence, potentially leading to more effective and lasting weight loss outcomes.

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

Research has shown that digital programs for weight loss can effectively help individuals who are overweight or obese shed pounds. One study found that participants in a weight loss program lost an average of 2.47% of their starting weight over six months. This trial will test various digital interventions, including the Core Behavioral Weight Loss (BWL) Intervention combined with different Behavior Change Technique (BCT) messages. Techniques such as planning actions and providing feedback on behavior, included in the BCT messages, have improved exercise and eating habits. Observing others' progress and receiving social support, also tested in this trial, can motivate weight loss. Digital programs that send real-time messages use these techniques to offer personalized support, aiding in better weight management. These methods show promise in helping young adults achieve their weight goals. ^{4 6 7 8 9}

Who Is on the Research Team?

Carmina G. Valle, PhD, MPH

Principal Investigator

Assistant Professor

Are You a Good Fit for This Trial?

This trial is for young adults with a BMI of 25-45 who speak English and have a smartphone. They should be physically inactive, not doing more than 210 minutes of exercise per week. People can't join if they're in another similar study, have certain mental health issues, are using appetite-affecting drugs (except stable SSRIs), or have serious health conditions that affect weight or physical activity.

Inclusion Criteria

Own a smartphone with a data and text messaging plan

Body mass index (BMI) of 25 - 45 kg/m^2 at baseline

English-speaking, reading, and writing

Exclusion Criteria

My thyroid condition is stable, with no medication changes in the last 6 months.

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)

Reside outside of the United States

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 6-month behavioral weight loss intervention using the Nudge mobile app, including daily BCT messages, self-monitoring, and tailored feedback

24 weeks

Daily assessments via app

Follow-up

Participants are monitored for adherence to weight loss behaviors and effectiveness of intervention messages

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Behavior Change Technique 1 Message (Action Planning)
• Behavior Change Technique 2 Message (Discrepancy between Current Behavior and Goal)
• Behavior Change Technique 3 Message (Feedback on Outcome of Behavior)
• Behavior Change Technique 4 Message (Social Support)
• Behavior Change Technique 5 Message (Social Comparison)
• Behavior Change Technique 6 Message (Social Reward)
• Behavior Change Technique 7 Message (Focus on Past Success)
• Core Behavioral Weight Loss (BWL) Intervention

Trial Overview The trial tests the effectiveness of personalized digital messages designed to help with weight loss. These messages use different behavior change techniques and are sent at optimal times to encourage daily achievement of weight-related goals during a comprehensive lifestyle intervention program.

How Is the Trial Designed?

Group I: Core Behavioral Weight Loss (BWL) Intervention Experimental Treatment 1 Intervention

Behavioral weight loss core intervention, includes activity tracker, wireless scale, daily self-weighing, and smartphone app with weekly behavioral lessons, food tracking log, weekly tailored feedback summary, and daily weight-related behavioral goals. Core intervention component is combined with each of the 7 intervention messages to be tested repeatedly over time.

Group II: Core BWL Intervention + BCT 7 Message (Focus on Past Success) Experimental Treatment 1 Intervention

Core BWL Intervention + Message testing the Behavior Change Technique "Focus on Past Success"

Group III: Core BWL Intervention + BCT 6 Message (Social Reward) Experimental Treatment 1 Intervention

Core BWL Intervention + Message testing the Behavior Change Technique "Social Reward"

Group IV: Core BWL Intervention + BCT 5 Message (Social Comparison) Experimental Treatment 1 Intervention

Core BWL Intervention + Message testing the Behavior Change Technique "Social Comparison"

Group V: Core BWL Intervention + BCT 4 Message (Social Support) Experimental Treatment 1 Intervention

Core BWL Intervention + Message testing the Behavior Change Technique "Social Support"

Group VI: Core BWL Intervention + BCT 3 Message (Feedback on Outcome of Behavior) Experimental Treatment 1 Intervention

Core BWL Intervention + Message testing the Behavior Change Technique "Feedback on Outcome of Behavior"

Group VII: Core BWL Intervention + BCT 2 Message (Discrepancy) Experimental Treatment 1 Intervention

Core BWL Intervention + Message testing the Behavior Change Technique "Discrepancy Between Current Behavior and Goal"

Group VIII: Core BWL Intervention + BCT 1 Message (Action Planning) Experimental Treatment 1 Intervention

Core BWL Intervention + Message testing the Behavior Change Technique "Action Planning"

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8365685/

Effective behavior change techniques to promote physical ... Effective behavior change techniques to promote physical activity in adults with overweight or obesity: A systematic review and meta‐analysis.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9403139/

Behaviour change techniques that constitute effective ... Action planning is a brief and effective behaviour change technique (BCT) to improve physical activity (PA) and diet behaviour (DB).

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/obr.13896?af=R

Behavior change techniques in low‐calorie and very ... Primary outcomes were weight change in kilograms (kg), change in Body Mass Index (BMI), or percentage weight loss. Reporting of anthropometrics ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2589555925001855

Effectiveness and active ingredients of digital behaviour ... The aim of this systematic review was to determine the effectiveness and active ingredients of digital behavior change interventions for improving weight and ...

5. ijbnpa.biomedcentral.com ijbnpa.biomedcentral.com/articles/10.1186/s12966-017-0494-y

Effective behaviour change techniques for physical activity ... The present review shows that behaviour change interventions for diet and PA are modestly effective both at short and long term, and that the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12127858/

Behaviour change techniques, intervention features and ... Selected apps contained a high number of behaviour change techniques and intervention features. Most included apps lacked an evidence base and safety features.

7. nyaspubs.onlinelibrary.wiley.com nyaspubs.onlinelibrary.wiley.com/doi/full/10.1111/nyas.15278

Behavior‐change lifestyle interventions for the treatment of ... This scoping review discusses optimal behavior-change lifestyle interventions in the treatment of overweight and obesity in children and adolescents.

8. ijbnpa.biomedcentral.com ijbnpa.biomedcentral.com/articles/10.1186/1479-5868-10-29

What are the most effective techniques in changing obese ... The aim of the current review was to identify which BCTs increase the self-efficacy and physical activity behaviour of obese adults.

9. mdpi.com mdpi.com/2076-328X/14/12/1143

Behavior Change Techniques in Physical Activity ... This systematic review aims to evaluate the application of BCTs in PA interventions for overweight and obese children and adolescents and to identify the most ...