Comparison of Intermittent Fasting With Continuous Caloric Reduction in Black Adults of Faith
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change in body weight
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Quality-of-Life Assessment (Other)
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.
干预措施: Quality-of-Life Assessment (Other)
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.
干预措施: Questionnaire Administration (Other)
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.
干预措施: Lifestyle Therapy (Behavioral)
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.
干预措施: Questionnaire Administration (Other)
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.
干预措施: Short-Term Fasting (Other)
结局指标
主要结局
Change in body weight
时间窗: Up to 6 months
Change in heart rate
时间窗: Up to 6 months
Change in blood pressure
时间窗: AT 6 months
Changes in body composition
时间窗: up to 6 months
Change in height
时间窗: up to 6 months
Change in waist circumference
时间窗: Up to t 6 months
Change in hip circumference
时间窗: Up to 6 months
次要结局
- Dietary intake(Up to 6 months)
- glucose metabolism(UP to 6 months)
- C-Peptide level(Up to 6 months)
- Obesity-related biomarker analysis(Up to 6 months)
- changes in Adipokine levels(Up to 6 months)