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NCT01131871 · ClinicalTrials.gov registry record · Phase 2

Innovative Approaches to Diet, Exercise and Activity

A Phase 2 study of Body Weight, sponsored by University of Pittsburgh.

Completed
Registry status
Phase 2
Development phase
471
Enrollment target
1
Study location

NCT01131871 is a Phase 2 study of Body Weight that has completed, run by University of Pittsburgh. The registered enrollment target is 471 participants, above the 264-participant average among 23 other Body Weight trials with a reported enrollment target (78% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT01131871, a Phase 2 study of Body Weight, has completed, sponsored by University of Pittsburgh.

COMPLETED
Registry status
Phase 2
Development phase
471 participants
Enrollment target
1
Study location

Study Summary

The prevalence of obesity in young adults has been increasing, and excessive body weight have been linked to numerous chronic conditions including cardiovascular disease, diabetes, many forms of cancer, and numerous musculoskeletal problems. This study will focus of the development and evaluation of interventions that may be appropriate for young adults (age 18-35 years) to improve weight loss outcomes following a 24 month intervention. The primary aim of this study is to examine whether an enhanced weight loss intervention (EWLI) that includes technology components results in improved weight loss in young adults (18-35 years of age) compared to a standard behavioral weight loss intervention (SBWP) over a period of 24 months. Eligible participants will also be assessed for body composition, body fat distribution, fitness, physical activity, dietary intake, and behavioral/psychosocial measures that may be predictive of behavior change. Assessments will occur at 0, 6, 12, 18, and 24 months. Subjects will participate in a 24 month behavioral weight loss program that includes a reduction in energy intake and moderate-to-vigorous intensity exercise (progressively increasing from 100 to 300 minutes per week). The technologies added to EWLI are text messaging, a wearable device that provides feedback on physical activity, and access to a website to monitor dietary behaviors.

Conditions Studied

Body Weight

Interventions

  • BEHAVIORAL Standard Behavioral Weight Loss Intervention
  • BEHAVIORAL Enhanced Weight Loss Intervention

Study Locations (1)

Pennsylvania

  • University of Pittsburgh - Pittsburgh

Trial Details

FieldValue
Enrollment Target 471 participants
Start Date 2010-09
Est. Completion 2014-11
Phase Phase 2

Sponsor

University of Pittsburgh

1,238 total trials

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What the Registry Record Tells You About NCT01131871

The ClinicalTrials.gov registry entry for NCT01131871 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 471 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 264-participant average among 23 other Body Weight trials with a reported enrollment target (78% higher). The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Body Weight appearing as the primary indexed condition, and to 2 interventions - of which Standard Behavioral Weight Loss Intervention is the first listed.

NCT01131871 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT01131871 about?

NCT01131871 is a clinical study titled "Innovative Approaches to Diet, Exercise and Activity". The prevalence of obesity in young adults has been increasing, and excessive body weight have been linked to numerous chronic conditions including cardiovascular disease, diabetes, many forms of cancer, and numerous musculoskeletal problems. This study will focus of the development and evaluation of...

What is the current status of trial NCT01131871?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 471 participants. The study started on 2010-09. Estimated completion is 2014-11.

What conditions does trial NCT01131871 study?

This clinical trial studies the following conditions: Body Weight.

What interventions are being tested in trial NCT01131871?

The interventions under investigation include: Standard Behavioral Weight Loss Intervention (BEHAVIORAL), Enhanced Weight Loss Intervention (BEHAVIORAL).

Who is sponsoring clinical trial NCT01131871?

This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01131871 being conducted?

This trial has 1 study location across Pennsylvania. 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 Editorial

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, or report a data error.