Obesity-Related Malignant Neoplasm Clinical Trial
Official title:
Comparison of Intermittent Fasting With Continuous Caloric Reduction in Black Adults of Faith
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. ;
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