Blood Glucose Monitoring, Metabolic Syndrome, Obesity & Overweight, Type 2 Diabetes Prevention
Conditions
Keywords
Carbohydrate-insulin model, Blood sugar balance, Weight loss, HbA1c, Intermittent fasting, Preventative nutrition, Dietary intervention, Women's health, Metabolic health, Case-control trial
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALSWW Method® Dietary and Lifestyle Intervention
A 12-week isocaloric dietary and lifestyle intervention based on the carbohydrate-insulin model (CIM), including: morning hydration, alkalizing with a dehydrated greens powder, intermittent fasting (12-16 hours overnight), conscious meal timing, a protein-forward diet (30+ grams per meal), non-starchy vegetables with every meal, limiting starchy carbohydrates to once per day, magnesium supplementation, and sleep support. Delivered through weekly group coaching calls, one-on-one nutrition coaching, daily food logging via the ATE™ app, and access to nutrition education materials.
Sponsors
Sarah Wragge Wellness
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Non-randomized case-control trial in which participants self-selected into either the SWW Method® dietary and lifestyle intervention group (cases) or a no-intervention control group through separate recruitment channels.
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Female * 35-75 years of age * No prior enrollment in the SWW Method® or Sarah Wragge Wellness® program.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight | 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 | Baseline and 12 weeks | Change in hemoglobin A1c (%) from baseline to 12 weeks, measured via Quest Diagnostics Comprehensive Health Profile |
| Change in BMI | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in LDL Cholesterol | Baseline and 12 weeks | Change in low-density lipoprotein cholesterol (mg/dL) from baseline to 12 weeks, measured via Quest Diagnostics lipid panel |
| Change in HDL Cholesterol | Baseline and 12 weeks | Change in high-density lipoprotein cholesterol (mg/dL) from baseline to 12 weeks, measured via Quest Diagnostics lipid panel |
| Change in Triglycerides | Baseline and 12 weeks | Change in triglycerides (mg/dL) from baseline to 12 weeks, measured via Quest Diagnostics lipid panel |
| Change in Total Cholesterol | Baseline and 12 weeks | Change in total cholesterol (mg/dL) from baseline to 12 weeks, measured via Quest Diagnostics lipid panel |
| Change in hsCRP | Baseline and 12 weeks | Change in high-sensitivity C-reactive protein (mg/L) from baseline to 12 weeks, measured via Quest Diagnostics Comprehensive Health Profile |
| Change in Blood Pressure | Baseline and 12 weeks | Change in systolic and diastolic blood pressure (mmHg) from baseline to 12 weeks, measured at Quest Diagnostics |
| Change in Waist Circumference | Baseline and 12 weeks | Change in waist circumference (inches) from baseline to 12 weeks, measured at Quest Diagnostics |
| Change in Vitamin D | Baseline and 12 weeks | Change in serum vitamin D (ng/mL) from baseline to 12 weeks, measured via Quest Diagnostics Comprehensive Health Profile |
Countries
United States
Outcome results
None listed