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NCT01671397 · ClinicalTrials.gov registry record · NA

Women's Health Project for Women Wanting to Lose Weight

A NA study, sponsored by Texas Tech University Health Sciences Center.

Completed
Registry status
NA
Development phase
40
Enrollment target

NCT01671397: Completed NA study, sponsored by Texas Tech University Health Sciences Center.

NCT01671397 is a NA study that has completed, run by Texas Tech University Health Sciences Center. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01671397, a NA study, has completed, sponsored by Texas Tech University Health Sciences Center.

COMPLETED
Registry status
NA
Development phase
40 participants
Enrollment target

Study Summary

The prevalence of obesity has steadily increased in the United States. This can lead to the worsening of type 2 diabetes mellitus, hypertension, sleep apnea, coronary artery disease and osteoarthritis. The medical management of obesity involves dietary counseling and education, behavioral counseling with goal setting, and exercise. Patients with short sleep periods in the range of 5 to 7 hours per night are often heavier than normal sleepers even after controlling for other factors. We hypothesize that the addition of focused counseling on healthy sleeping to counseling on healthy eating (dieting) and healthy exercise can help women lose weight.

Primary Outcome

Patients will be monitored for weight loss over a six month study period. We estimate that the sleep hygiene intervention group will lose 10 pounds more than the control group.

Interventions

  • BEHAVIORAL Diet and exercise counseling
  • BEHAVIORAL Diet, exercise, sleep hygiene counseling

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2012-09
Est. Completion 2014-02
Phase NA

What the finished NCT01671397 record still lists

NCT01671397 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 2 interventions - of which Diet and exercise counseling is the first listed.

NCT01671397 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01671397 about?

NCT01671397 is a clinical study titled "Women's Health Project for Women Wanting to Lose Weight". The prevalence of obesity has steadily increased in the United States. This can lead to the worsening of type 2 diabetes mellitus, hypertension, sleep apnea, coronary artery disease and osteoarthritis. The medical management of obesity involves dietary counseling and education, behavioral counseling...

What is the current status of trial NCT01671397?

This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2012-09. Estimated completion is 2014-02.

What interventions are being tested in trial NCT01671397?

The interventions under investigation include: Diet and exercise counseling (BEHAVIORAL), Diet, exercise, sleep hygiene counseling (BEHAVIORAL).

Who is sponsoring clinical trial NCT01671397?

This trial is sponsored by Texas Tech University Health Sciences Center, which has 76 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01671397's enrollment target sits among peer trials

40 1447th of 2000 higher than 465 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 NCT01671397, the US trial registry maintained by the National Library of Medicine. NCT01671397 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.