NCT00040287

Brief Summary

The purpose of this study is to examine a new theory for understanding the processes that govern behavior change by observing how people's beliefs and feelings about smoking cessation or weight loss change as they participate in smoking cessation or weight control programs. This study also seeks to improve the ability of treatment programs to help people maintain changes in their behavior.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
1,778

participants targeted

Target at P75+ for phase_3

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1999

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 25, 2002

Completed
Last Updated

May 17, 2007

Status Verified

May 1, 2007

First QC Date

June 24, 2002

Last Update Submit

May 16, 2007

Conditions

Keywords

smokingobesityweight losssmoking cessationweight control

Interventions

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Eligibility criteria for the smoking cessation studies were: between 18 and 60 years old, a minimum 2-year history of smoking, a current level of smoking \> 10 cigarettes per day, and agreement to participate in the study. Eligibility requirements for the weight loss studies were: between 18 and 60 years old, body mass index (weight/height2) \> 27.0, 20 percent or more above desirable weight according to medical standards, and consent to participate. Smokers and overweight persons were excluded if currently being treated by a physician for a serious physical or psychological disorder (e.g., heart disease, cancer, depression). Women were excluded if currently pregnant, pregnant in the last 6 months, or intending to become pregnant in the next 18 months. People who were overweight and who also smoked were considered eligible for participation in either weight loss or smoking cessation programs. However, they received treatment only for the particular behavior problem targeted by the study they chose to participate in.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota, Division of Epidemiology, School of Public Health, Epidemiology Clinic Research Center, Suite 201, 1100 Washington Avenue South

Minneapolis, Minnesota, 55415, United States

Location

MeSH Terms

Conditions

SmokingObesityWeight LossSmoking Cessation

Condition Hierarchy (Ancestors)

BehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesHealth Behavior

Study Officials

  • Robert Jeffery, Ph.D.

    University of Minnesota, Division of Epidemiology, School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

June 24, 2002

First Posted

June 25, 2002

Study Start

January 1, 1999

Last Updated

May 17, 2007

Record last verified: 2007-05

Locations