| NCT ID | NCT05530538 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Los Angeles |
| Condition | Weight Loss |
| Study Type | INTERVENTIONAL |
| Enrollment | 38 participants |
| Start Date | 2023-11-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 38 participants in total. It began in 2023-11-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Childhood obesity within the United States has been a growing concern over the past number of years, and if not addressed, leads to detrimental health outcomes for youth as they move into adulthood. The literature suggests that over-eating, especially when framed in terms of food addiction, plays a key role in this epidemic; however, treatment options are time intensive, posing a profound logistical barrier for both the child and parent and often limits or prevents engagement. As research within the field of mHealth has grown, technology-based interventions have gained traction, specifically interactive smartphone applications (apps). Displacement theory, although not new, has been understudied yet provides a strong explanation and treatment plan for addictive type behaviors. The core of this theory posits that problems which one feels they cannot face nor avoid leads to repetitive and irrepressible behaviors; however, if a healthy coping behavior can be learned and utilized, then the unhealthy behavior will cease. The theory lends itself well to being adapted into an mHealth format, making it more easily accessible and more widely used. Grounded in displacement theory, the proposed study aims to develop an app-based weight loss intervention for adolescents with obesity. Information gained regarding the feasibility and acceptability of such an intervention can potentially be replicated and applied to other populations with various addictive behaviors. Helping those with addictive behaviors in a format that has little to no logistical barriers can have a substantial impact on public health. A novel smartphone app will be designed by key stakeholders and refined through the course of the study. 38 total adolescents (14-21 years old) with %BMIp85 will be recruited via various sources (e.g., clinic referrals, flyers, social media advertising) to participate in one of two stages of the study: the beta testing stage or the trial stage. Beta testing will enroll one group of eight teens to test the app for three weeks; participants will be assessed in-person pre- and post-intervention. After each group, the app will be modified to incorporate their feedback in order to promote youth engagement. The trial stage will enroll 30 adolescents to participate in a four-month intervention; participants will complete three assessments, baseline, post-intervention (both in-person) and one-month post-intervention (either in-person or virtually). The study will examine engagement and satisfaction with the app, as well as the intervention's impact on clinical outcome measures (weight and BMI, diet and snacking, and addictive behaviors related to food and substance use) and potential mediators/moderators (motivation for change, perceived stress, and distress tolerance).
Eligibility Criteria
Inclusion Criteria: 1. 14-21 years old 2. Has an iPhone or are willing to use a study iPhone 3. Ability to read and speak English 4. Endorsement of one of the three items listed below on the five-item S-weight questionnaire indicating motivation for change During the last year I haven't done anything to lose weight but I'm planning to do something over the next 30 days. I've been making an effort to lose weight (by dieting1 and/or exercising2) for less than 6 months. I've been making an effort to maintain my weight (by dieting1 and/or exercising2) for more than 6 months. 6\. Body mass index \[BMI\] ≥85th percentile for age and gender Exclusion Criteria: 1. Any psychiatric condition and/or developmental delay which would require immediate or ongoing treatment that would make study participation difficult or harmful 2. Parent/guardian-reported physical, mental of other inability to provide consent or refusal to provide consent for minor children 3. Self-reported diagnosis of Prader-Willi Syndrome, brain tumor, hypothalamic obesity, or other diagnosis associated with obesity 4. Concurrent participation in an alternative weight loss intervention 5. Participation in the study team's previous app weight loss studies (exclusion for trial but not beta testing participants)
Contact & Investigator
Vibha Singhal, MD, MBBS, MPH
PRINCIPAL INVESTIGATOR
University of California, Los Angeles
Frequently Asked Questions
Who can join the NCT05530538 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 21 Years, studying Weight Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05530538 currently recruiting?
Yes, NCT05530538 is actively recruiting participants. Contact the research team at amhuynh@mednet.ucla.edu for enrollment information.
Where is the NCT05530538 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT05530538 clinical trial?
NCT05530538 is sponsored by University of California, Los Angeles. The principal investigator is Vibha Singhal, MD, MBBS, MPH at University of California, Los Angeles. The trial plans to enroll 38 participants.