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NCT06151145 · ClinicalTrials.gov registry record · NA

Stepped Care for Weight Loss Maintenance

A NA study of Obesity, sponsored by Johns Hopkins University.

Recruiting
Registry status
NA
Development phase
180
Enrollment target
1
Study location

NCT06151145: Recruiting NA study of Obesity, sponsored by Johns Hopkins University.

NCT06151145 is a NA study of Obesity that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 180 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06151145, a NA study of Obesity, is actively recruiting participants, sponsored by Johns Hopkins University.

RECRUITING
Registry status
NA
Development phase
180 participants
Enrollment target
1
Study location

Study Summary

This study is a 3-group, parallel design, randomized controlled trial (RCT) in approximately 258 adults with obesity that will investigate whether a 16-week behavioral weight loss treatment and a 52-week stepped-care digital health intervention can improve the maintenance of a ≥ 5% weight loss. 16-week run-in (Phase 1). To qualify for randomization, participants must lose ≥ 5% of initial weight in the 16-week run-in. This loss will be achieved with the provision of weekly-group lifestyle counseling, which includes a partial meal replacement diet. 52-week randomized trial of 3 weight loss maintenance strategies (Phase 2): Participants who have achieved ≥ 5% weight loss during Phase 1 will be randomly assigned to 1 of 3 groups: 1. Participants in the Usual Care group will be emailed monthly educational modules with information on maintaining weight loss. 2. Participants in the SELF group will receive a wireless "smart" body weight scale and a wearable physical activity tracker, and daily text messages with tailored feedback to assist in weight loss maintenance. 3. Participants in the STEP group will be enrolled in an intervention that consists of 4 steps that are progressive and based on response to treatment. After 13 weeks at each step, participants who do not maintain a ≥5% weight loss or regain 2 percentage points of weight from the participants randomization value will move to a higher intensity step. Participants who maintain weight loss will stay at the same step.

Conditions Studied

Obesity

Interventions

  • BEHAVIORAL STEP
  • BEHAVIORAL Usual care
  • BEHAVIORAL SELF

Study Locations (1)

Maryland

  • Johns Hopkins University - Baltimore

Trial Details

FieldValue
Enrollment Target 180 participants
Start Date 2024-02-01
Est. Completion 2028-06
Phase NA

Sponsor

Johns Hopkins University

1,448 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06151145

The ClinicalTrials.gov registry entry for NCT06151145 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (78% lower). The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Obesity appearing as the primary indexed condition, and to 3 interventions - of which STEP is the first listed.

NCT06151145 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT06151145 about?

NCT06151145 is a clinical study titled "Stepped Care for Weight Loss Maintenance". This study is a 3-group, parallel design, randomized controlled trial (RCT) in approximately 258 adults with obesity that will investigate whether a 16-week behavioral weight loss treatment and a 52-week stepped-care digital health intervention can improve the maintenance of a ≥ 5% weight loss. 16-...

What is the current status of trial NCT06151145?

This trial is currently recruiting. It is a NA study. The enrollment target is 180 participants. The study started on 2024-02-01. Estimated completion is 2028-06.

What conditions does trial NCT06151145 study?

This clinical trial studies the following conditions: Obesity.

What interventions are being tested in trial NCT06151145?

The interventions under investigation include: STEP (BEHAVIORAL), Usual care (BEHAVIORAL), SELF (BEHAVIORAL).

Who is sponsoring clinical trial NCT06151145?

This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06151145 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.