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

206 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this micro-randomized trial is to evaluate the effects of 7 types of intervention messages targeting specific behavior change techniques (i.e., BCT messages) delivered in "just-in-time" (JIT) moments on daily achievement of weight-related behavioral goals among n=201 young adults with overweight and obesity, participating in a digital, mobile comprehensive lifestyle intervention. "Just-in-time adaptive interventions" (JITAIs) are an alternative to the "one size fits all" approach of mobile intervention development that can provide tailored, real-time messaging and support for young adults.

Research Team

Carmina G. Valle, PhD, MPH

Principal Investigator

Assistant Professor

Eligibility Criteria

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

Treatment Details

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.

Participant Groups

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+