Weight Loss Interventions for Black Adults of Faith

Obesity-Related Malignant Neoplasm Clinical Trial

Official title:

Comparison of Intermittent Fasting With Continuous Caloric Reduction in Black Adults of Faith

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04557540
• Other study ID #: I 684220
• Secondary ID: NCI-2020-06640I
• Status: Completed
• Phase: N/A
• Start date: September 25, 2021
• Est. completion date: December 7, 2022

Study information

• Verified date: January 2024
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 7, 2022
• Est. primary completion date: December 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Obesity-Related Malignant Neoplasm

Intervention

Behavioral:
• Lifestyle Therapy
Receive The WORD lifestyle CER weight loss intervention

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies
• Short-Term Fasting
Receive Fasting WORD intermittent fasting weight loss intervention

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight		Up to 6 months
Primary	Changes in body composition		up to 6 months
Primary	Change in height		up to 6 months
Primary	Change in heart rate		Up to 6 months
Primary	Change in blood pressure		AT 6 months
Primary	Change in waist circumference		Up to t 6 months
Primary	Change in hip circumference		Up to 6 months
Secondary	Dietary intake	Dietary intake will be assessed by the interview-administered Nutrition Data System for Research (NDSR).	Up to 6 months
Secondary	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
Secondary	glucose metabolism	Change from baseline	UP to 6 months
Secondary	changes in Adipokine levels	blood concentration measure	Up to 6 months
Secondary	C-Peptide level		Up to 6 months