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Weight Loss Interventions for Black Adults of Faith

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ClinicalTrials.gov Identifier: NCT04557540
Recruitment Status : Recruiting
First Posted : September 21, 2020
Last Update Posted : January 26, 2022
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Obesity-Related Malignant Neoplasm Behavioral: Lifestyle Therapy Other: Quality-of-Life Assessment Other: Questionnaire Administration Other: Short-Term Fasting Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparison of Intermittent Fasting With Continuous Caloric Reduction in Black Adults of Faith
Actual Study Start Date : August 25, 2020
Estimated Primary Completion Date : September 15, 2022
Estimated Study Completion Date : September 15, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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.
 Behavioral: Lifestyle Therapy
Receive The WORD lifestyle CER weight loss intervention

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies


Outcome Measures
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Primary Outcome Measures :
  1. Change in body weight [ Time Frame: Up to 6 months ]
  2. Changes in body composition [ Time Frame: up to 6 months ]
  3. Change in height [ Time Frame: up to 6 months ]
  4. Change in heart rate [ Time Frame: Up to 6 months ]
  5. Change in blood pressure [ Time Frame: AT 6 months ]
  6. Change in waist circumference [ Time Frame: Up to t 6 months ]
  7. Change in hip circumference [ Time Frame: Up to 6 months ]

Secondary Outcome Measures :
  1. Dietary intake [ Time Frame: Up to 6 months ]
    Dietary intake will be assessed by the interview-administered Nutrition Data System for Research (NDSR).

  2. Obesity-related biomarker analysis [ 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.

  3. glucose metabolism [ Time Frame: UP to 6 months ]
    Change from baseline

  4. changes in Adipokine levels [ Time Frame: Up to 6 months ]
    blood concentration measure

  5. C-Peptide level [ Time Frame: Up to 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04557540


Locations
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United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Karen Yeary    716-845-1300 ext 6231    Karen.Yeary@roswellpark.org   
Principal Investigator: Karen Yeary         
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
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Principal Investigator: Karen Yeary Roswell Park Cancer Institute
More Information
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Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT04557540    
Other Study ID Numbers: I 684220
NCI-2020-06640 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 684220 ( Other Identifier: Roswell Park Cancer Institute )
First Posted: September 21, 2020    Key Record Dates
Last Update Posted: January 26, 2022
Last Verified: January 2022

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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
Additional relevant MeSH terms:
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Neoplasms