Nutritional Counseling

The Effects of Physical Activity and Nutritional Counseling on Smoking Cessation Among Low Income African American Smokers – Randomized Control Trial

Group 3

Table of Contents

Project Abstract……………………………………………………………………………..… 3
Project Narrative…………………………………………………………………………….… 4
Facilities/Equipment………………………………………………………………………..… 5
Biosketches……………………………………………………………………………………. 6
Specific Aims…………………………………………………………………………….…... 11
Research Plan………………………………………………………………………………… 12 Background and Significance………………………………………………..….… 12 Approach…………………………………………………………………………….. 14 Hypothesis………………………………………………………………….. 14 Design and Randomization……………………………………………….. 14 Recruitment…..................................................................................... 14
Our hypothesis is that low-income African American smokers, randomized to participate in the physical activity intervention arm, will have higher rates of smoking cessation, significant weight loss, less withdrawal symptoms and longer periods of abstinence after one year.
The proposed study will be a prospective randomized controlled trial. We will use a parallel design with two treatment arms and will follow participants for 12 months. Both arms will receive the standard treatment (nicotine replacement therapy and smoking cessation counseling). In addition, the intervention arm will include physical activity and nutrition counseling. We will request the participants to engage in moderate physical activity for 150 minutes per week and we will collect the number of steps counts and weekly activity
The outcome will be continuous. Aligning with the goals of the intervention, the PASC arm is anticipated to have a 5% weight loss at 6 months of follow-up. The comparator arm is anticipated to have no weight loss or potential weight gain. Using estimates of mean weight loss of 0% for the comparator arm and 5% weight loss in the PASC arm and a range of estimates for standard deviation (0.5x the mean, equal to the mean, and 1.5x the mean), we calculated sample size requirements for 80% and 90% power using SAS 9.3 procedure for difference between means with alpha set at 0.025 to allow for multiple comparisons. The resulting sample sizes are summarized in Table 2. We have selected the most conservative estimate for sample size as our target for recruitment. Adjusted for the 75% retention rate, our target sample size for 80% power, alpha level of 0.025 is 120 (60 per