Weight Loss Interventions for Black Adults of Faith
- Conditions
- Obesity-Related Malignant Neoplasm
- Interventions
- Behavioral: Lifestyle TherapyOther: Quality-of-Life AssessmentOther: Questionnaire AdministrationOther: Short-Term Fasting
- Registration Number
- NCT04557540
- Lead Sponsor
- Roswell Park Cancer Institute
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm II (The WORD) Questionnaire Administration 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. Arm I (Fasting WORD) Questionnaire Administration 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. Arm I (Fasting WORD) Short-Term Fasting 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. Arm II (The WORD) Lifestyle Therapy 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. Arm I (Fasting WORD) Quality-of-Life Assessment 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. Arm II (The WORD) Quality-of-Life Assessment 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.
- Primary Outcome Measures
Name Time Method Change in body weight 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 Changes in body composition up to 6 months Change in waist circumference Up to t 6 months Change in hip circumference Up to 6 months
- Secondary Outcome Measures
Name Time Method Dietary intake Up to 6 months Dietary intake will be assessed by the interview-administered Nutrition Data System for Research (NDSR).
glucose metabolism UP to 6 months Change from baseline
C-Peptide level Up to 6 months Obesity-related biomarker analysis 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.
changes in Adipokine levels Up to 6 months blood concentration measure
Trial Locations
- Locations (1)
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States