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NCT02109068 · ClinicalTrials.gov registry record · Phase 3

Lifestyle, Exercise and Nutrition Study 1

A Phase 3 study, sponsored by Yale University.

Completed
Registry status
Phase 3
Development phase
100
Enrollment target

NCT02109068: Completed Phase 3 study, sponsored by Yale University.

NCT02109068 is a Phase 3 study that has completed, run by Yale University. The registered enrollment target is 100 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02109068, a Phase 3 study, has completed, sponsored by Yale University.

COMPLETED
Registry status
Phase 3
Development phase
100 participants
Enrollment target

Study Summary

The specific aims of this study are to determine the efficacy and cost-effectiveness of a weight loss program compared with usual care (control) treatment on 6-month changes in body weight, body fat, and serum hormones in breast cancer survivors.

Primary Outcome

BMI will be calculated using weight and height measurements (weight (kg)/height (m)\^2 ). Weight and height will be measured by research staff blinded to the participant's randomization group at baseline and 6-months. Participants will be weighed in light indoor clothing, without shoes, rounding up to the nearest 0.1 kg; height will be measured in a standard manner, without shoes, using a stadiometer, rounding up to the nearest 0.1 cm. All measures will be performed and recorded twice in success

Interventions

  • BEHAVIORAL Weight Loss Counseling- Phone
  • BEHAVIORAL Weight Loss Counseling- In-Person

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2011-01
Est. Completion 2014-01
Phase Phase 3
Yale University

1,492 total trials

What the finished NCT02109068 record still lists

NCT02109068 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).

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

NCT02109068 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02109068 about?

NCT02109068 is a clinical study titled "Lifestyle, Exercise and Nutrition Study 1". The specific aims of this study are to determine the efficacy and cost-effectiveness of a weight loss program compared with usual care (control) treatment on 6-month changes in body weight, body fat, and serum hormones in breast cancer survivors.

What is the current status of trial NCT02109068?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2011-01. Estimated completion is 2014-01.

What interventions are being tested in trial NCT02109068?

The interventions under investigation include: Weight Loss Counseling- Phone (BEHAVIORAL), Weight Loss Counseling- In-Person (BEHAVIORAL).

Who is sponsoring clinical trial NCT02109068?

This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02109068's enrollment target sits among peer trials

100 1681st of 2000 higher than 288 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT02109068, the US trial registry maintained by the National Library of Medicine. NCT02109068 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.