Weight Loss Interventions for Black Adults of Faith

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.

Study Overview

• Status: Completed
• Conditions: Obesity-Related Malignant Neoplasm
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Short-Term Fasting; Behavioral: Lifestyle Therapy

Detailed Description

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
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• African American/Black
• Body mass index (BMI) > 25 kg/m^2
• Associated with a participating church through membership or participation in a church activity
• Cleared by a Primary Care Provider (PCP-Doctor) to be a part of the study
• Not currently on weight loss medications
• Not pregnant or lactating
• Has not lost at least 10% of their body weight in the last 6 months
• Has not had bariatric surgery in the last 10 years
• Able to walk unassisted and continuously for 10 minutes

Exclusion Criteria:

• Adults unable to consent
• Adults unable to complete study measures in English
• Individuals who are not yet adults (infants, children, teenagers)
• Individuals who are pregnant or lactating
• Adults who have had a myocardial infarction (heart attack) or stroke without medical clearance from their primary care physician to participate in the study
• Adults who currently have type 1 or type 2 diabetes without medical clearance from their primary care physician to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (Fasting WORD); 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.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Other: Short-Term Fasting; Receive Fasting WORD intermittent fasting weight loss intervention; Other Names: Intermittent Fasting; Short-term Intermittent Fasting
Experimental: Arm II (The WORD); 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.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Behavioral: Lifestyle Therapy; Receive The WORD lifestyle CER weight loss intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Investigators: Principal Investigator: Karen Yeary, Roswell Park Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2021
• Primary Completion (Actual): December 7, 2022
• Study Completion (Actual): December 7, 2022

Study Registration Dates

• First Submitted: September 9, 2020
• First Submitted That Met QC Criteria: September 15, 2020
• First Posted (Actual): September 21, 2020

Study Record Updates

• Last Update Posted (Actual): January 16, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: I 684220 (Other Identifier: Roswell Park Cancer Institute); NCI-2020-06640 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No