Participants complete the 12-month Precision Nutrition Coaching Program web-based lifestyle intervention consisting of physical activity at home or a local gym, nutritional/lifestyle habit with a new focus biweekly, and educational lessons about health, nutrition, fitness, or behavior change.

Complete web-based lifestyle intervention

Lifestyle Therapy

Quality-of-Life Assessment

Questionnaire Administration

Julia Devonish

This early phase I trial studies how well a web-based lifestyle intervention called Precision Nutrition Coaching Program works in improving health in African American cancer survivors. Participating in the web-based lifestyle intervention program reinforced with experienced lifestyle coaches and consisting of physical activity, nutritional/lifestyle habits, and educational lessons may help to improve overall health and well-being, fitness level, and quality of life in African American cancer survivors.

PRIMARY OBJECTIVE:

I. To conduct a pilot implementation research study to determine the viability, safety, and effectiveness of the use of a 12-month, commercially available, web-based lifestyle behavioral medicine intervention program by individuals who are or have been a Witness Role Model (WRM) in the National Witness Project (NWP).

SECONDARY OBJECTIVE:

I. To examine the feasibility of this research to subsequently investigate the effects of optimal health and/or lifestyle related behavioral medicine interventions used to promote optimal health on mitigating cancer-related and overall mortality disparities in African Americans (AA), and comorbidity/ chronic disease(s) management over time. (EXPLORATORY)

OUTLINE:

Participants complete the 12-month Precision Nutrition Coaching Program web-based lifestyle intervention consisting of physical activity at home or a local gym, nutritional/lifestyle habit with a new focus biweekly, and educational lessons about health, nutrition, fitness, or behavior change.

Web-Based Lifestyle Intervention for the Improvement of Health in African American Cancer Survivors

African American Cancer Survivor Health: Pilot Implementation Research (National Witness Project® Witness Role Models Use Precision Nutrition)

Measured by participation and online tracking of activity completion (workout, habit, and lessons). An overall adherence score will be calculated by averaging the percentage of time each of the 3 activities were completed by each participant over the 12-month intervention.

Will be measured by the proportion of participants who are still participating in the study at the end of the 12-month intervention.

Biweekly inquiries about possible injuries will be conducted.

The effects of the lifestyle intervention program will be ascertained via primarily subjective, self-reported assessments administered at pre-intervention, post-intervention, and a follow-up. Subjective data will be validated through the collection of objective data in a subset of local participants via in-person assessments. Generalized linear mixed model methods, specifically a repeated measures analysis of variance with a random participant effect, as well as fixed effects for time and interaction will be used.

Roswell Park Cancer Institute

Symptoms and General Pathology

All Conditions

Nutritional and Metabolic Diseases

Weight Loss

Obesity

Body Weight

Participants receive the Fasting WORD intermittent fasting weight loss intervention consisting of 16 small-group lessons over 1.5 hours each QW for 2 months and then Q2W for 4 months.

Participants receive The WORD CER weight loss intervention consisting of 16 small-group lessons over 1.5 hours each QW for 2 months and then Q2W for 4 months.

Receive The WORD lifestyle CER weight loss intervention

Receive Fasting WORD intermittent fasting weight loss intervention

Short-Term Fasting

Karen Yeary

This trial compares the effect of intermittent fasting versus continuous caloric reduction for the reduction of body weight in Black adults of faith. Intermittent fasting and continuous caloric reduction interventions may help Black adults of faith lose weight, improve their health, and help reduce cancer risk.

PRIMARY OBJECTIVES:

I. Partner with the First Ladies of Western New York (FLOW) to engage 10 community stakeholders from Black churches in the Roswell Park Catchment area in a four-stage process involving information gathering, discussion groups, and mock intervention delivery to create Fasting WORD for Black adults of faith.

II. Implement and determine the initial comparative effectiveness of Fasting WORD with The WORD to reduce body weight, and biomarkers of obesity, inflammation, insulin, and insulin resistance.

SECONDARY OBJECTIVES:

I. Examine the interventions' effects on diet and physical activity. II. Examine participants' adherence and satisfaction with both interventions.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants receive the Fasting WORD intermittent fasting weight loss intervention consisting of 16 small-group lessons over 1.5 hours each once a week (QW) for 2 months and then once every 2 weeks (Q2W) for 4 months.

ARM II: Participants receive The WORD continuous energy restriction (CER) weight loss intervention consisting of 16 small-group lessons over 1.5 hours each QW for 2 months and then Q2W for 4 months.

After completion of study, participants are followed up for 30 days.

Weight Loss Interventions for Black Adults of Faith

Comparison of Intermittent Fasting With Continuous Caloric Reduction in Black Adults of Faith

Dietary intake will be assessed by the interview-administered Nutrition Data System for Research (NDSR).

Will measure biomarkers related to , including C-peptide, as a marker of insulin secretion Will assay for 6 adipokines including leptin, adiponectin, adipsin, lipocalin-2/NGAL, resistin, and PAI-1 (total) as markers of adiposity and adiposity-related metabolic dysfunction, including insulin resistance, and CRP as a well-characterized and validated marker for systemic inflammation.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Web-Based Lifestyle Intervention for the Improvement of Health in African American Cancer Survivors	NCT04290962	Cancer Survivor	Lifestyle Thera... Quality-of-Life... Questionnaire A...	21 Years -	Roswell Park Cancer Institute
Weight Loss Interventions for Black Adults of Faith	NCT04557540	Obesity-Related...	Lifestyle Thera... Quality-of-Life... Questionnaire A... Short-Term Fast...	18 Years -	Roswell Park Cancer Institute
Web-Based Lifestyle Intervention for the Improvement of Health in African American Cancer Survivors	NCT04290962	Cancer Survivor	Lifestyle Thera... Quality-of-Life... Questionnaire A...	21 Years -	Roswell Park Cancer Institute
Weight Loss Interventions for Black Adults of Faith	NCT04557540	Obesity-Related...	Lifestyle Thera... Quality-of-Life... Questionnaire A... Short-Term Fast...	18 Years -	Roswell Park Cancer Institute
Weight Loss Interventions for Black Adults of Faith	NCT04557540	Obesity-Related...	Lifestyle Thera... Quality-of-Life... Questionnaire A... Short-Term Fast...	18 Years -	Roswell Park Cancer Institute

Spots Global Cancer Trial Database for lifestyle therapy