Quit and Fit: A Tobacco Cessation and Energy Balance Pilot for African Americans

NCT02103582 | Completed

• 1 other identifier: 2012-1516 Georgetown Lombardi
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The Quit \& Fit intervention will be designed as a 12-week study to promote smoking cessation, increase physical activity levels, and reduce weight gain through regular exercise and healthy nutrition for African American Women smokers. Patients will be assigned to the fitness intervention group or control groups by a computer.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Smoking cessation

  12 weeks

Secondary Outcomes (1)

• weight loss

  12 weeks

Study Arms (2)

control

PLACEBO COMPARATOR

Participants who are randomized to the 'control arm' will be asked to maintain their current daily activities for 12 weeks. They will also be required to visit the study site 3 times per week for 12 weeks to view videos on different wellness topics. Control participants will have anthropometric measurements of weight, height, hip size and waist size taken at the beginning of the study, 6 weeks, and at 12 weeks. Control participants will also have a fitness test on a treadmill, full body scan, blood pressure, heart rate and questionnaires given at the beginning of the study, 6 weeks and at 12 weeks.

Other: Intervention

intervention

EXPERIMENTAL

Participants who are randomized to the 'intervention arm' will be asked to come to the study site to exercise 3 days per week for 12 weeks. The exercise duration will increase over time from 75 minutes per week to 150 minutes per week. Intervention participants will have anthropometric measurements of weight, height, hip size and waist size taken at the beginning of the study, 6 weeks, and at 12 weeks. Intervention participants will also have a fitness test on a treadmill, full body scan, blood pressure, heart rate and questionnaires given at the beginning of the study, 6 weeks and at 12 weeks.

Other: Intervention

Interventions

Intervention OTHER

Participants who are randomized to the 'intervention arm' will be asked to come to the study site to exercise 3 days per week for 12 weeks. The exercise duration will increase over time from 75 minutes per week to 150 minutes per week. Intervention participants will have anthropometric measurements of weight, height, hip size and waist size taken at the beginning of the study, 6 weeks, and at 12 weeks. Intervention participants will also have a fitness test on a treadmill, full body scan, blood pressure, heart rate and questionnaires given at the beginning of the study, 6 weeks and at 12 weeks.

control; intervention

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• African American women ages 18-69;
• Currently smoke at least 5 cigarettes per day;
• Smoked daily for the past one year;
• Able to provide informed consent;
• Generally good health as determined by medical history;
• Able to participate in exercise training.

You may not qualify if:

• Women who are:
• Currently pregnant; or have
• heart disease,
• lung disease, or
• mental illness

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (1)

Georgetown University Lombardi community site office

Washington D.C., District of Columbia, 20003, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Methods

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Oncology

Study Record Dates

• First Submitted: March 27, 2014
• First Posted: April 4, 2014
• Study Start: April 1, 2013
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 29, 2017

Record last verified: 2017-11

Locations

US (1)