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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: Clinical Trial NA study, sponsored by Icahn School of Medicine at Mount Sinai.

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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

Height will be measured to the nearest millimeter using a direct reading stadiometer. Weight will be assessed to the nearest 0.1 kg using a digital scale (Tanita TBF-300A) with participants wearing light clothing without shoes or coats.

Interventions

  • BEHAVIORAL Healthy Weight
  • BEHAVIORAL Controlled Intervention

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2013-11
Est. Completion 2015-09
Phase NA

Why NCT02011646 stopped before completion

NCT02011646 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 2 interventions - of which Healthy Weight is the first listed.

NCT02011646 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT02011646's enrollment target sits among peer trials

80 994th of 2000 higher than 941 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02011646, the US trial registry maintained by the National Library of Medicine. NCT02011646 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.