Weight Loss Interventions for Black Adults of Faith

NCT04557540 | Completed DMC

• 2 other identifiers: I 684220NCI-2020-06640
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity-Related Malignant Neoplasm

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (5)

• Dietary intake

  Up to 6 months

• Obesity-related biomarker analysis

  Up to 6 months

• glucose metabolism

  UP to 6 months

• changes in Adipokine levels

  Up to 6 months

• C-Peptide level

  Up to 6 months

Study Arms (2)

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.

Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Short-Term Fasting

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.

Behavioral: Lifestyle Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Lifestyle Therapy BEHAVIORAL

Receive The WORD lifestyle CER weight loss intervention

Arm II (The WORD)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (Fasting WORD); Arm II (The WORD)

Questionnaire Administration OTHER

Ancillary studies

Arm I (Fasting WORD); Arm II (The WORD)

Short-Term Fasting OTHER

Receive Fasting WORD intermittent fasting weight loss intervention

Also known as: Intermittent Fasting, Short-term Intermittent Fasting

Arm I (Fasting WORD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Study Officials

• Karen Yeary

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 21, 2020
• Study Start: September 25, 2021
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022
• Last Updated: January 16, 2024

Record last verified: 2024-01

Locations

US (1)