NCT01162577

Brief Summary

The purpose of the "Weigh2Quit" study was to test in a randomized trial, a "weight concerns" intervention designed to reduce weight concerns that might impact cessation, increase physical activity and adherence to tobacco treatment, increase confidence in quitting, improve tobacco quit rates and decrease weight gain post-quit.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2008

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

March 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 14, 2010

Completed
Last Updated

July 14, 2010

Status Verified

July 1, 2010

Enrollment Period

1 year

First QC Date

July 13, 2010

Last Update Submit

July 13, 2010

Conditions

Keywords

WeightSmokingQuitline

Outcome Measures

Primary Outcomes (1)

  • 30 day abstinence

    No smoking in the past 30 days

    6 months

Secondary Outcomes (1)

  • Change in weight

    6 months

Study Arms (2)

Intervetion

EXPERIMENTAL

The intervention group received the 5 standard tobacco calls plus 3 weight calls with a weight coach to address weight concerns related to quitting smoking

Behavioral: Weight Concerns

Control

NO INTERVENTION

Participants in this arm received only the 5 standard tobacco calls

Interventions

Weight ConcernsBEHAVIORAL

Standard Quitline plus weight coaching

Also known as: Standard Quitline
Intervetion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals were eligible for the study if they were age 18 or older, smoked at least 5 cigarettes per day, were willing to quit within 30 days from enrollment in the Helpline, were not pregnant or nursing, agreed to be in the study and randomized, agreed to the follow-up interview, provided a workable phone number with a secondary back-up number, had a BMI of at least 23 and reported having significant concerns about gaining weight with quitting.

You may not qualify if:

  • Individuals were not eligible for the study if they had a BMI lower than 23 or were pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Free & Clear

Seattle, Washington, 98104, United States

Location

Related Publications (2)

  • Bush T, Levine MD, Deprey M, Cerutti B, Zbikowski SM, McAfee T, Mahoney L, Beebe L. Prevalence of Weight Concerns and Obesity Among Smokers Calling a Quitline. J Smok Cessat. 2008 Dec 1;4(5):74-78. doi: 10.1375/jsc.4.2.74.

  • Bush T, Levine MD, Beebe LA, Cerutti B, Deprey M, McAfee T, Boeckman L, Zbikowski S. Addressing weight gain in smoking cessation treatment: a randomized controlled trial. Am J Health Promot. 2012 Nov-Dec;27(2):94-102. doi: 10.4278/ajhp.110603-QUAN-238.

MeSH Terms

Conditions

SmokingBody Weight

Condition Hierarchy (Ancestors)

BehaviorSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Terry Bush, PhD

    Free & Clear, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 13, 2010

First Posted

July 14, 2010

Study Start

March 1, 2008

Primary Completion

March 1, 2009

Study Completion

September 1, 2009

Last Updated

July 14, 2010

Record last verified: 2010-07

Locations