Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
NCT Number: NCT04557540
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Buffalo, New York, 14263, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Receive The WORD lifestyle CER weight loss intervention
Ancillary studies
Other names: Quality of Life Assessment
Ancillary studies
Receive Fasting WORD intermittent fasting weight loss intervention
Other names: Intermittent Fasting, Short-term Intermittent Fasting
Time frame: Up to 6 months
Time frame: up to 6 months
Time frame: up to 6 months
Time frame: Up to 6 months
Time frame: AT 6 months
Time frame: Up to t 6 months
Time frame: Up to 6 months
Time frame: Up to 6 months
Dietary intake will be assessed by the interview-administered Nutrition Data System for Research (NDSR).
Time frame: Up to 6 months
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
Change from baseline
Time frame: Up to 6 months
blood concentration measure
Time frame: Up to 6 months
Roswell Park Cancer Institute
Other
Comparison of Intermittent Fasting With Continuous Caloric Reduction in Black Adults of Faith
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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