Clinical trial NCT04557540: Weight Loss Interventions for Black Adults of Faith
Official title: Comparison of Intermittent Fasting With Continuous Caloric Reduction in Black Adults of Faith
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity-Related Malignant Neoplasm
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2020-09-21
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in body weight
timeFrame: Up to 6 months
measure: Changes in body composition
timeFrame: up to 6 months
measure: Change in height
timeFrame: up to 6 months
measure: Change in heart rate
timeFrame: Up to 6 months
measure: Change in blood pressure
timeFrame: AT 6 months
measure: Change in waist circumference
timeFrame: Up to t 6 months
measure: Change in hip circumference
timeFrame: Up to 6 months
Secondary outcomes:
measure: Dietary intake
timeFrame: Up to 6 months
measure: Obesity-related biomarker analysis
timeFrame: Up to 6 months
measure: glucose metabolism
timeFrame: UP to 6 months
measure: changes in Adipokine levels
timeFrame: Up to 6 months
measure: C-Peptide level
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Karen Yeary
role: PRINCIPAL_INVESTIGATOR
References: