Evaluating the SWW Method® Dietary Intervention for HbA1c and Weight Management as a Preventative Intervention in Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Change in Body Weight
研究概览
简要总结
This study evaluated the SWW Method®, a 12-week dietary and lifestyle intervention based on the carbohydrate-insulin model, in a healthy cohort of women aged 35-75. The study assessed whether the intervention resulted in significant improvements in blood glucose markers (HbA1c, fasting blood glucose), weight, BMI, and other metabolic markers compared to a no-intervention control group. The SWW Method® protocol includes intermittent fasting, a protein-forward diet, meal sequencing, hydration, magnesium supplementation, and sleep support. This was a non-randomized case-control trial with 45 intervention participants and 40 controls, conducted over 12 weeks.
详细描述
The SWW Method® study is a non-randomized case-control trial in which participants self-selected into either the SWW Method® intervention group (cases) or a no-intervention control group through separate recruitment channels. Primary, secondary, and exploratory outcome measures were compared between the two groups.
This 12-week trial was designed to evaluate the SWW Method®'s effect on blood sugar balance and weight loss in a moderately healthy population of women aged 35-75. Cases completed the six-week SWW Method® program, followed by six weeks of coach-supported accountability via the ATE™ app. Questionnaires and lab work were collected one week before and six weeks after the intervention to assess changes over the 12-week period.
The SWW Method® is an isocaloric carbohydrate-insulin model (CIM)-based protocol designed to support blood sugar balance and weight loss through: adequate hydration, alkalizing with a daily greens powder, intermittent fasting, conscious meal timing, a protein-forward diet, non-starchy vegetables with every meal, limiting starchy carbohydrate intake to once per day, magnesium supplementation, and optimizing circadian rhythm. The protocol is delivered through nutrition education, group coaching, and one-on-one nutrition support.
Participants completed a Comprehensive Health Profile through Quest Diagnostics at baseline and 12 weeks, including a complete blood count (CBC), comprehensive metabolic panel (CMP), lipid/cholesterol panel, urinalysis, hemoglobin A1c (HbA1c), vitamin D, and high-sensitivity C-reactive protein (hsCRP), as well as biometrics including height, weight, waist circumference, and blood pressure.
The primary outcome was change in HbA1c / fasting blood glucose and weight / BMI between baseline and 12 weeks. Secondary outcomes included changes in lipid markers, blood pressure, C-reactive protein, and other lab and biometric measures. Statistical analysis was performed using the Wilcoxon signed-rank test for within-group comparisons and difference-in-differences regression for between-group comparisons.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •35-75 years of age
- •No prior enrollment in the SWW Method® or Sarah Wragge Wellness® program.
排除标准
- •History of non-skin-related cancer diagnosis or treatment within the past five years.
- •Currently taking weight loss medication, including semaglutide
- •Currently taking any medication for blood sugar or diabetes management.
- •Previous enrollment in the SWW Method® or any Sarah Wragge Wellness® program.
研究组 & 干预措施
Intervention group (cases)
Participants enrolled in the 12-week SWW Method® dietary and lifestyle intervention program. During the first six weeks, cases completed the SWW Method® program including a structured nutrition protocol, one-on-one coaching, group coaching calls, daily food logging via the ATE™ app, and supplementation with SWW Alkalize® and SWW Restore®. During the final six weeks, participants received continued coach access and nutrition education materials to support ongoing adherence.
干预措施: SWW Method® Dietary and Lifestyle Intervention (Behavioral)
Control group
Participants received no dietary or lifestyle intervention. Controls completed the same baseline and follow-up questionnaires and lab testing at identical timepoints as the intervention group for comparison purposes.
结局指标
主要结局
Change in Body Weight
时间窗: Baseline and 12 weeks
Change in body weight (lbs) from baseline to 12 weeks, measured at Quest Diagnostics
Change in HbA1c Time Frame: Baseline and 12 weeks
时间窗: Baseline and 12 weeks
Change in hemoglobin A1c (%) from baseline to 12 weeks, measured via Quest Diagnostics Comprehensive Health Profile
Change in BMI
时间窗: Baseline and 12 weeks
Change in body mass index from baseline to 12 weeks, calculated from height and weight measured at Quest Diagnostics
Change in Fasting Blood Glucose
时间窗: Baseline and 12 weeks
Change in fasting blood glucose (mg/dL) from baseline to 12 weeks, measured via Quest Diagnostics Comprehensive Health Profile following 8-12 hour fast
次要结局
- Change in LDL Cholesterol(Baseline and 12 weeks)
- Change in HDL Cholesterol(Baseline and 12 weeks)
- Change in Triglycerides(Baseline and 12 weeks)
- Change in Total Cholesterol(Baseline and 12 weeks)
- Change in hsCRP(Baseline and 12 weeks)
- Change in Blood Pressure(Baseline and 12 weeks)
- Change in Waist Circumference(Baseline and 12 weeks)
- Change in Vitamin D(Baseline and 12 weeks)
研究者
Megan B Grover
Principal Investigator
Sarah Wragge Wellness