Evaluating the SWW Method Dietary Intervention for HbA1c and Weight Management as a Preventative Intervention in Women

Evaluating the SWW Method® Dietary Intervention for HbA1c and Weight Management as a Preventative Intervention in Women

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome; Obesity & Overweight; Type 2 Diabetes Prevention; Blood Glucose Monitoring
• Intervention / Treatment: Behavioral: SWW Method® Dietary and Lifestyle Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10028
      • Sarah Wragge Wellness

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: SWW 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body Weight	Change in body weight (lbs) from baseline to 12 weeks, measured at Quest Diagnostics	Baseline and 12 weeks
Change in HbA1c Time Frame: Baseline and 12 weeks	Change in hemoglobin A1c (%) from baseline to 12 weeks, measured via Quest Diagnostics Comprehensive Health Profile	Baseline and 12 weeks
Change in BMI	Change in body mass index from baseline to 12 weeks, calculated from height and weight measured at Quest Diagnostics	Baseline and 12 weeks
Change in Fasting Blood Glucose	Change in fasting blood glucose (mg/dL) from baseline to 12 weeks, measured via Quest Diagnostics Comprehensive Health Profile following 8-12 hour fast	Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in LDL Cholesterol	Change in low-density lipoprotein cholesterol (mg/dL) from baseline to 12 weeks, measured via Quest Diagnostics lipid panel	Baseline and 12 weeks
Change in HDL Cholesterol	Change in high-density lipoprotein cholesterol (mg/dL) from baseline to 12 weeks, measured via Quest Diagnostics lipid panel	Baseline and 12 weeks
Change in Triglycerides	Change in triglycerides (mg/dL) from baseline to 12 weeks, measured via Quest Diagnostics lipid panel	Baseline and 12 weeks
Change in Total Cholesterol	Change in total cholesterol (mg/dL) from baseline to 12 weeks, measured via Quest Diagnostics lipid panel	Baseline and 12 weeks
Change in hsCRP	Change in high-sensitivity C-reactive protein (mg/L) from baseline to 12 weeks, measured via Quest Diagnostics Comprehensive Health Profile	Baseline and 12 weeks
Change in Blood Pressure	Change in systolic and diastolic blood pressure (mmHg) from baseline to 12 weeks, measured at Quest Diagnostics	Baseline and 12 weeks
Change in Waist Circumference	Change in waist circumference (inches) from baseline to 12 weeks, measured at Quest Diagnostics	Baseline and 12 weeks
Change in Vitamin D	Change in serum vitamin D (ng/mL) from baseline to 12 weeks, measured via Quest Diagnostics Comprehensive Health Profile	Baseline and 12 weeks

Collaborators and Investigators

• Sponsor: Sarah Wragge Wellness

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): June 6, 2025
• Study Completion (Actual): August 31, 2025

Study Registration Dates

• First Submitted: March 5, 2026
• First Submitted That Met QC Criteria: March 5, 2026
• First Posted (Actual): March 11, 2026

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: HbA1c; Weight loss; Metabolic health; Intermittent fasting; Women's health; Dietary intervention; Carbohydrate-insulin model; Blood sugar balance; Preventative nutrition; Case-control trial
• Additional Relevant MeSH Terms: Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Body Weight Changes; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Feeding Behavior; Fasting; Overweight; Obesity; Weight Loss; Metabolic Syndrome; Intermittent Fasting
• Other Study ID Numbers: Pro00077176

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared publicly due to privacy and ethical restrictions. The data supporting the findings of this study are available from the corresponding author upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No