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Digital Weight Loss Intervention for Obesity (Nudge Trial)

N/A
Recruiting
Led By Carmina G. Valle, PhD, MPH
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 months
Awards & highlights

Nudge Trial Summary

This trial tests tailored messages for young adults with overweight/obesity to help them achieve weight-related goals in real-time.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this is a behavioral intervention focusing on messaging for weight loss support, there aren't direct medical side effects like you'd expect from medication. However, participants may experience stress or frustration if they don't meet their goals or find it difficult to follow the program.

Nudge Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
At or under daily red foods limit
Met daily active minutes goal
Met daily weighing goal
Secondary outcome measures
At or under daily red foods limit tomorrow
Met daily active minutes goal tomorrow
Met daily weighing goal tomorrow
+7 more

Nudge Trial Design

8Treatment groups
Experimental Treatment
Group I: Core Behavioral Weight Loss (BWL) InterventionExperimental Treatment1 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 Treatment1 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 Treatment1 Intervention
Core BWL Intervention + Message testing the Behavior Change Technique "Social Reward"
Group IV: Core BWL Intervention + BCT 5 Message (Social Comparison)Experimental Treatment1 Intervention
Core BWL Intervention + Message testing the Behavior Change Technique "Social Comparison"
Group V: Core BWL Intervention + BCT 4 Message (Social Support)Experimental Treatment1 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 Treatment1 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 Treatment1 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 Treatment1 Intervention
Core BWL Intervention + Message testing the Behavior Change Technique "Action Planning"

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,508 Previous Clinical Trials
4,190,624 Total Patients Enrolled
64 Trials studying Obesity
57,853 Patients Enrolled for Obesity
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,840 Previous Clinical Trials
47,851,923 Total Patients Enrolled
251 Trials studying Obesity
205,855 Patients Enrolled for Obesity
Carmina G. Valle, PhD, MPHPrincipal InvestigatorAssistant Professor
3 Previous Clinical Trials
379 Total Patients Enrolled

Media Library

Behavior Change Technique 1 Message (Action Planning) Clinical Trial Eligibility Overview. Trial Name: NCT05625061 — N/A
Obesity Research Study Groups: Core Behavioral Weight Loss (BWL) Intervention, Core BWL Intervention + BCT 1 Message (Action Planning), Core BWL Intervention + BCT 2 Message (Discrepancy), Core BWL Intervention + BCT 3 Message (Feedback on Outcome of Behavior), Core BWL Intervention + BCT 4 Message (Social Support), Core BWL Intervention + BCT 5 Message (Social Comparison), Core BWL Intervention + BCT 6 Message (Social Reward), Core BWL Intervention + BCT 7 Message (Focus on Past Success)
Obesity Clinical Trial 2023: Behavior Change Technique 1 Message (Action Planning) Highlights & Side Effects. Trial Name: NCT05625061 — N/A
Behavior Change Technique 1 Message (Action Planning) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05625061 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies in this research project for participants?

"According to clinicaltrials.gov, this investigation is not enrolling participants currently; the original listing was published on January 1st 2023 and updated most recently on November 14th 2022. However, there are 1223 other trials actively looking for patients at present."

Answered by AI

What criteria must individuals meet to be considered for this research endeavor?

"This research study necessitates 201 participants aged 18 to 35 with a BMI between 25 and 45 kg/m^2. Additionally, candidates must be able to converse in English, own an internet-connected smartphone, and have less than 210 minutes of intense physical activity weekly at the start of the trial."

Answered by AI

Are individuals aged 55 and older permitted to enter this experiment?

"The maximum age for qualification into this trial is 35 years old, with a minimum of 18."

Answered by AI

What are the overarching goals of this investigation?

"The primary aim of this trial, evaluated over the 24 week period, is to achieve a daily weight goal. Secondary objectives include absolute weight change (in kilograms), number of red foods consumed in one day, and percentual alteration in body mass index. Weight will be measured digitally at home and the latter value ascertained by comparing baseline figures with those obtained after 6 months."

Answered by AI

Who else is applying?

What site did they apply to?
University of North Carolina at Chapel Hill
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Just-in-time Adaptive Intervention Messaging in a Digital Weight Loss Intervention for Young Adults
2023. "Just-in-time Adaptive Intervention Messaging in a Digital Weight Loss Intervention for Young Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05625061.
All > Weight Loss High Point > Overweight
~116 spots leftby Apr 2025
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