Weight Loss Interventions for Black Adults of Faith

Study Overview
=================
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.

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

Conditions
-----------------
Obesity-Related Malignant Neoplasm

Intervention / Treatment
-----------------
* Behavioral: Lifestyle Therapy
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration
* Other: Short-Term Fasting


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (Fasting WORD)<br>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<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Short-Term Fasting<br>* Receive Fasting WORD intermittent fasting weight loss intervention<br>* Other names: Short-term Intermittent Fasting;|
| Experimental: Arm II (The WORD)<br>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<br>* Receive The WORD lifestyle CER weight loss intervention<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |