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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-06640 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| I 684220 | Other Identifier | Roswell Park Cancer Institute |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (Fasting WORD) | Experimental | 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. |
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| Arm II (The WORD) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle Therapy | Behavioral | Receive The WORD lifestyle CER weight loss intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | Up to 6 months | |
| Changes in body composition | up to 6 months | |
| Change in height | up to 6 months | |
| Change in heart rate | Up to 6 months | |
| Change in blood pressure | AT 6 months | |
| Change in waist circumference | Up to t 6 months | |
| Change in hip circumference | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Dietary intake | Dietary intake will be assessed by the interview-administered Nutrition Data System for Research (NDSR). | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Yeary | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Short-Term Fasting | Other | Receive Fasting WORD intermittent fasting weight loss intervention |
|
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| Up to 6 months |
| glucose metabolism | Change from baseline | UP to 6 months |
| changes in Adipokine levels | blood concentration measure | Up to 6 months |
| C-Peptide level | Up to 6 months |