Food Delivery + Smoking Cessation Counseling for Tobacco Addiction

Overseen By Sandilyn Bullock, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arkansas

Disqualifiers: Live outside specified counties, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

540 Participants Needed

Trial Summary

What is the purpose of this trial?

The long-term goal of FRESH Delivers is to fill a critical gap in knowledge on the role of a home-based food delivery social intervention in the elimination of tobacco-caused cancer health disparities. The central hypothesis is that smokers who receive real-time video-based motivational counseling and home-based food deliveries will have greater cotinine-verified 7-day point prevalence abstinence than those who receive real-time video-based motivational counseling alone or home food delivery alone. The rationale for this approach is that studies show increased odds of smoking cessation with increasing food security.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Food Delivery + Smoking Cessation Counseling for Tobacco Addiction?

Research shows that home food delivery can improve household food environments and nutritional status, which may support healthier lifestyle changes. Additionally, smoking cessation counseling is a well-established method to help people quit smoking. Combining these approaches could potentially enhance overall health and support quitting smoking. ^{1 2 3 4 5}

Is the combination of food delivery and smoking cessation counseling safe for humans?

The studies suggest that smoking cessation counseling, including telephone quitlines and in-person coaching, is generally safe and effective. The combination of food assistance and smoking cessation interventions has been tested in food pantry settings without reported safety concerns, indicating it is likely safe for humans. ^{6 7 8 9 10}

How is the Food Delivery + Smoking Cessation Counseling treatment different from other smoking cessation treatments?

This treatment is unique because it combines home-based food delivery with smoking cessation counseling, offering both nutritional support and behavioral therapy to help people quit smoking, which is not a common combination in existing smoking cessation programs. ^{6 7 11 12 13}

Research Team

Pebbles Fagan, PhD

Principal Investigator

University of Arkansas

Eligibility Criteria

This trial is for regular smokers aged 21-75 living in Desha, Phillips, Chicot, or Lee Counties who are interested in quitting. Participants must have smoked for at least a year and be willing to use study-provided tech for communication and COVID-19 symptom reporting. They need an active phone, home address, email, and speak English.

Inclusion Criteria

I am willing to use a study-provided tablet or phone.

Working phone, home address, and email

Live in Desha, Phillips, Chicot, or Lee Counties

Exclusion Criteria

Persons who do not meet the above criteria.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive real-time video-based motivational counseling and/or home-based food delivery

6 months

Monthly visits (virtual or in-person)

Follow-up

Participants are monitored for smoking cessation and changes in nicotine dependence

6 months

Monthly assessments

Extension

Participants may continue to receive interventions to maintain smoking cessation

Long-term

Treatment Details

Interventions

• Food delivery
• Smoking cessation counseling

Trial Overview The FRESH Delivers trial tests if video-based motivational counseling combined with home food deliveries increases the chances of quitting smoking compared to either strategy alone. The belief is that better food security might help people stop smoking.

Participant Groups

Group I: TRTsocialmot1 arm Experimental Treatment 1 Intervention

Smokers will receive real-time video-based motivational counseling and home-based food delivery. Participants will receive educational material.

Group II: TRTsocial2 arm Active Control 1 Intervention

Smokers will receive home-based food delivery only. Participants will receive educational material.

Group III: TRTmot3 arm Active Control 1 Intervention

Smokers will receive real-time video-based motivational counseling only. Participants will receive educational material.

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+

Findings from Research

A pilot study with 28 overweight participants showed that using a grocery home delivery service alongside standard behavioral weight loss treatment significantly reduced the number of foods in the home, particularly high-fat items.

While both treatment groups lost similar amounts of weight over 8 weeks, there was a trend suggesting that more frequent home deliveries correlated with weight loss, indicating potential benefits of this approach for healthier eating habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home grocery delivery improves the household food environments of behavioral weight loss participants: results of an 8-week pilot study. Gorin, AA., Raynor, HA., Niemeier, HM., et al.[2021]

The 8-week personalized nutrition intervention for mobile food pantry users resulted in a significant average weight loss of 2.3% among participants, indicating its effectiveness in promoting weight management.

While the treatment group showed a greater improvement in diet quality compared to the control group, this change was not statistically significant, suggesting that while the intervention is promising, further research is needed to confirm its impact on dietary habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Feasibility and Pilot Study of a Personalized Nutrition Intervention in Mobile Food Pantry Users in Northeastern Connecticut. Marmash, D., Ha, K., Sakaki, JR., et al.[2021]

Dietary counseling, with or without oral nutrition supplementation, does not significantly reduce 30-day mortality in hospitalized malnourished adults but may slightly reduce 6-month mortality and complications, based on a meta-analysis of 16 studies.

The evidence suggests that dietary counseling can improve nutrition status and may reduce hospital readmission rates, although the certainty of these findings varies and further research is needed to standardize counseling methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of dietary counseling with or without nutrition supplementation in hospitalized patients who are malnourished or at risk of malnutrition: A systematic review and meta-analysis. Wong, A., Huang, Y., Sowa, PM., et al.[2022]

Patients using the Meals on Wheels system had a mean total daily food intake that was 236 grams higher compared to those in the control group, indicating improved nutritional support.

The Meals on Wheels program not only reduced food waste but also enhanced patient satisfaction regarding food choice, quality, and organization, suggesting a more effective meal distribution system for hospitalized patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Higher food intake and appreciation with a new food delivery system in a Belgian hospital. Meals on Wheels, a bedside meal approach: a prospective cohort trial. Goeminne, PC., De Wit, EH., Burtin, C., et al.[2015]

A study involving 74 elderly women (ages 70-90) showed that those using a food delivery service for over 3 months had better nutritional markers, such as higher serum protein and cholesterol levels, compared to those living alone without the service.

The findings suggest that food delivery services can effectively improve the nutritional status of elderly individuals living alone, indicating a potential strategy for enhancing their dietary intake and overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effects of a food delivery service on the nutritional status of elderly persons living at home alone]. Sakemoto, S., Furuie, T., Horinouchi, K., et al.[2011]

Connecting primary care clinics to a state-level quit line in Oregon was successful, with 745 out of 15,662 identified smokers referred for tobacco cessation support, demonstrating the feasibility of this approach.

The cost of connecting patients to the quit line was initially $15 to $22 per patient in the first year, but this dropped to $4 to $6 in subsequent years, indicating a cost-effective strategy for increasing tobacco cessation support in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility of connecting physician offices to a state-level tobacco quit line. Bentz, CJ., Bayley, KB., Bonin, KE., et al.[2022]

A randomized controlled trial involving 3,282 callers to the California Smokers' Helpline demonstrated that those receiving up to seven counseling sessions had significantly higher smoking abstinence rates compared to those who only received self-help materials, with 12-month abstinence rates of 9.1% versus 6.9% respectively (P<0.001).

The study found that counseling approximately doubled the abstinence rates when comparing those who received counseling to those who did not, indicating that telephone counseling is an effective real-world intervention for smoking cessation, supporting public health initiatives to increase access to quitlines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence of real-world effectiveness of a telephone quitline for smokers. Zhu, SH., Anderson, CM., Tedeschi, GJ., et al.[2022]

Smoking cessation counseling provided by physicians and trained health professionals can lead to abstinence rates between 2.1% and 17.4%, indicating some effectiveness in helping people quit smoking.

However, the overall clinical effect of smoking cessation counseling is considered low, and long-term cessation rates remain uncertain, suggesting a need for further cost-effectiveness analyses before widespread implementation in public health programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Counseling interventions for smoking cessation: systematic review]. Alba, LH., Murillo, R., Castillo, JS.[2019]

A system-based approach at food distribution sites, involving trained personnel as quit-smoking coaches, successfully enrolled 86 clients in smoking cessation programs, with an impressive attendance rate of 82% for scheduled sessions.

The study demonstrated a smoking cessation rate of 19%-36% among participants, alongside 100% adherence to food nudging guidelines, indicating that food pantries can effectively support both smoking cessation and healthier dietary choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing the feasibility of a system-based approach to deliver a smoking cessation and food nudging intervention at food pantry sites. Patterson, F., Robson, S., McGarry, C., et al.[2022]

A study involving 144 food assistance recipients revealed that 50% were current smokers, and many had serious cardiovascular health issues, such as hypertension (72.3%) and diabetes (34.3%).

A low-intensity smoking cessation education intervention increased knowledge about quitting smoking but did not significantly change participants' intentions to quit; only 7% of smokers used the state quit line, highlighting the need for more effective strategies to address tobacco use and cardiovascular health in low-income populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing Cardiovascular Health and Evaluating a Low-Intensity Intervention to Promote Smoking Cessation in a Food-Assistance Population. Perkett, M., Robson, SM., Kripalu, V., et al.[2018]

Proactive telephone counselling significantly increases smoking quit rates compared to minimal intervention controls, with an odds ratio of 1.56 based on a meta-analysis of 27 trials involving various smoking cessation strategies.

The effectiveness of telephone support as an addition to face-to-face counselling or nicotine replacement therapy remains unclear, indicating that while it can be beneficial, it may not provide additional advantages in all contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone counselling for smoking cessation. Stead, LF., Lancaster, T., Perera, R.[2020]

A study involving 100 tobacco users showed that standardized tobacco cessation counselling (TCC) significantly improved behavior change scores over 12 weeks, indicating its effectiveness in helping individuals quit smoking.

The mean behavior change score increased from 32.78 at baseline to 48.7 by the end of the study, demonstrating sustained positive behavioral changes among participants after receiving TCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of tobacco cessation counselling and behavioural changes Using Multi Theory Model (MTM): A follow-up study. Kumar, V., Sabbarwal, B., Jaggi, A., et al.[2022]

The article presents a structured approach called the 'five A's' (Ask, Advise, Assess, Assist, Arrange) to help clinicians effectively promote tobacco cessation among patients, even within time constraints.

While the focus is on brief interventions, the article also provides insights for more intensive strategies and tips for engaging less motivated patients in their journey to quit smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting tobacco cessation and relapse prevention. Kenford, SL., Fiore, MC.[2015]

References

1. England pubmed.ncbi.nlm.nih.gov

Home grocery delivery improves the household food environments of behavioral weight loss participants: results of an 8-week pilot study. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

A Feasibility and Pilot Study of a Personalized Nutrition Intervention in Mobile Food Pantry Users in Northeastern Connecticut. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of dietary counseling with or without nutrition supplementation in hospitalized patients who are malnourished or at risk of malnutrition: A systematic review and meta-analysis. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Higher food intake and appreciation with a new food delivery system in a Belgian hospital. Meals on Wheels, a bedside meal approach: a prospective cohort trial. [2015]

5. Japan pubmed.ncbi.nlm.nih.gov

[Effects of a food delivery service on the nutritional status of elderly persons living at home alone]. [2011]

6. Netherlands pubmed.ncbi.nlm.nih.gov

The feasibility of connecting physician offices to a state-level tobacco quit line. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Evidence of real-world effectiveness of a telephone quitline for smokers. [2022]

8. Mexico pubmed.ncbi.nlm.nih.gov

[Counseling interventions for smoking cessation: systematic review]. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Testing the feasibility of a system-based approach to deliver a smoking cessation and food nudging intervention at food pantry sites. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Characterizing Cardiovascular Health and Evaluating a Low-Intensity Intervention to Promote Smoking Cessation in a Food-Assistance Population. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Telephone counselling for smoking cessation. [2020]

12. India pubmed.ncbi.nlm.nih.gov

Effectiveness of tobacco cessation counselling and behavioural changes Using Multi Theory Model (MTM): A follow-up study. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Promoting tobacco cessation and relapse prevention. [2015]