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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
44
Receive The WORD lifestyle CER weight loss intervention
Ancillary studies
Ancillary studies
Roswell Park Cancer Institute
Buffalo, New York, United States
Change in body weight
Time frame: Up to 6 months
Changes in body composition
Time frame: up to 6 months
Change in height
Time frame: up to 6 months
Change in heart rate
Time frame: Up to 6 months
Change in blood pressure
Time frame: AT 6 months
Change in waist circumference
Time frame: Up to t 6 months
Change in hip circumference
Time frame: Up to 6 months
Dietary intake
Dietary intake will be assessed by the interview-administered Nutrition Data System for Research (NDSR).
Time frame: Up to 6 months
Obesity-related biomarker analysis
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.
Time frame: Up to 6 months
glucose metabolism
Change from baseline
Time frame: UP to 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Receive Fasting WORD intermittent fasting weight loss intervention
changes in Adipokine levels
blood concentration measure
Time frame: Up to 6 months
C-Peptide level
Time frame: Up to 6 months