206 Participants Needed

Digital Weight Loss Intervention for Obesity

(Nudge Trial)

KE
Overseen ByKaren E Hatley, MPH, RD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of North Carolina, Chapel Hill
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

CG

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
See 13 more

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?
8Treatment groups
Experimental Treatment
Group I: Core Behavioral Weight Loss (BWL) InterventionExperimental Treatment1 Intervention
Group II: Core BWL Intervention + BCT 7 Message (Focus on Past Success)Experimental Treatment1 Intervention
Group III: Core BWL Intervention + BCT 6 Message (Social Reward)Experimental Treatment1 Intervention
Group IV: Core BWL Intervention + BCT 5 Message (Social Comparison)Experimental Treatment1 Intervention
Group V: Core BWL Intervention + BCT 4 Message (Social Support)Experimental Treatment1 Intervention
Group VI: Core BWL Intervention + BCT 3 Message (Feedback on Outcome of Behavior)Experimental Treatment1 Intervention
Group VII: Core BWL Intervention + BCT 2 Message (Discrepancy)Experimental Treatment1 Intervention
Group VIII: Core BWL Intervention + BCT 1 Message (Action Planning)Experimental Treatment1 Intervention

Find a Clinic Near You

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+
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