NCT00177697

Brief Summary

The purpose of this study to examine the effect of having a weight loss mentor on long-term weight loss in overweight adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 1999

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1999

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2002

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

September 15, 2005

Status Verified

September 1, 2005

First QC Date

September 13, 2005

Last Update Submit

September 13, 2005

Conditions

Weight LossObesity

Outcome Measures

Primary Outcomes (1)

  • weight loss

Secondary Outcomes (3)

  • fitness

  • dietary intake

  • mediators

Interventions

behavioral weight loss programBEHAVIORAL

Eligibility Criteria

Age21 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female
  • years of age
  • BMI = 25-35 kg/m2
  • Ability to provide informed consent.
  • Ability to provide consent from their personal physician to participate in this study.

You may not qualify if:

  • Reporting regular exercise participation of at least 20 minutes per day on at least 3 days per week during the previous six months. (This study is designed to recruit relatively sedentary adults.)
  • Diabetes, hypothyroidism, or other medical conditions which would affect energy metabolism.
  • Currently pregnant, pregnant within the previous six months, or planning on becoming pregnant within the next 12 months. (Pregnancy will be based on self-report and will be included on the detailed medical history that is completed by subjects.)
  • Non-medicated resting systolic blood pressure \>160 mmHg or non-medicated resting diastolic blood pressure \>100 mmHg, or taking medication that would affect blood pressure.
  • Taking medication that would affect resting heart rate or the heart rate response during exercise (e.g., beta blockade).
  • Arrhythmia on resting or exercise electrocardiogram that would indicate that vigorous exercise was contraindicated.
  • History of myocardial infarction or valvular disease.
  • History of orthopedic complications that would prevent optimal participation in the exercise component (e.g., heel spurs, severe arthritis).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15203, United States

Location

MeSH Terms

Conditions

Weight LossObesity

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • John M Jakicic, Ph.D.

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

September 1, 1999

Study Completion

July 1, 2002

Last Updated

September 15, 2005

Record last verified: 2005-09

Locations

US(1)