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NCT02011646 · ClinicalTrials.gov registry record · NA
Healthy Body Study
A NA study, sponsored by Icahn School of Medicine at Mount Sinai.
- Terminated
- Registry status
- NA
- Development phase
- 80
- Enrollment target
NCT02011646 is a NA study that was terminated before completion, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 80 participants.
The verdict
NCT02011646, a NA study, was terminated before completion, sponsored by Icahn School of Medicine at Mount Sinai.
- TERMINATED
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
Study Summary
Few obesity prevention programs have produced weight gain prevention effects that persist over long-term follow-up and those that have are extremely lengthy, averaging 52 hr in duration, making implementation difficult and costly. The 2010 US Preventative Services Task Force (USPSTF) recommendations for treating child \& adolescent obesity state that programs should have ≥ 25 hr of comprehensive treatment including dietary, physical activity and behavioral counseling, and that programs with \< 25 hr usually do not produce improvements. The implication is that, if centers cannot provide this level of service (as most cannot), it is not worth providing any kind of treatment at all. In extreme exception to this, an intensive 3-hr non-restrictive obesity prevention program involving participant-driven healthy lifestyle improvement plans designed to bring caloric intake and output into balance (Healthy Weight) has been found to significantly reduce increases in BMI and obesity onset relative to alternative interventions and assessment-only controls through 3-yr follow-up. We propose to test an extended 6-hr version of the Healthy Weight intervention in a sample of primarily low SES, minority adolescents and young adults who are overweight and report body dissatisfaction and subthreshold eating disorder symptoms, as these are prevalent risk factors for obesity. We will test the hypothesis that participants assigned to the Healthy Weight vs. control intervention will have significantly lower BMI and % body fat during follow-up. Secondary outcomes will include body dissatisfaction, depressive symptoms, and eating disorder symptoms. 300 adolescents and young adults at high risk for future weight gain by virtue of their age, BMI percentile, body dissatisfaction and eating disorder symptomatology will be randomized to Healthy Weight or weight control educational video. Participants will complete assessments of BMI, body composition, potential mediators, and other outcomes at p
Interventions
- BEHAVIORAL Healthy Weight
- BEHAVIORAL Controlled Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2013-11 |
| Est. Completion | 2015-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02011646
The ClinicalTrials.gov registry entry for NCT02011646 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Healthy Weight is the first listed.
NCT02011646 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02011646 about?
NCT02011646 is a clinical study titled "Healthy Body Study". Few obesity prevention programs have produced weight gain prevention effects that persist over long-term follow-up and those that have are extremely lengthy, averaging 52 hr in duration, making implementation difficult and costly. The 2010 US Preventative Services Task Force (USPSTF) recommendations...
What is the current status of trial NCT02011646?
This trial is currently terminated. It is a NA study. The enrollment target is 80 participants. The study started on 2013-11. Estimated completion is 2015-09.
What interventions are being tested in trial NCT02011646?
The interventions under investigation include: Healthy Weight (BEHAVIORAL), Controlled Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT02011646?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
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