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

NCT07463417 | Completed

• 1 other identifier: Pro00077176
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome; Obesity & Overweight; Blood Glucose Monitoring; Type 2 Diabetes Prevention

Keywords

Carbohydrate-insulin model; Blood sugar balance; Weight loss; HbA1c; Intermittent fasting; Preventative nutrition; Dietary intervention; Women's health; Metabolic health; Case-control trial

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• 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

Study Arms (2)

Intervention group (cases)

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

SWW Method® Dietary and Lifestyle Intervention BEHAVIORAL

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.

Intervention group (cases)

Eligibility Criteria

• Age: 35 Years - 75 Years
• Gender Eligibility Details: Female only. The study was designed to evaluate the SWW Method® dietary and lifestyle intervention specifically in women aged 35-75, as the program is designed for and marketed to a female population.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• years of age
• No prior enrollment in the SWW Method® or Sarah Wragge Wellness® program.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sarah Wragge Wellness: lead

Study Sites (1)

Sarah Wragge Wellness

New York, New York, 10028, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome; Obesity; Overweight; Weight Loss; Intermittent Fasting

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Fasting; Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 11, 2026
• Study Start: April 1, 2024
• Primary Completion: June 6, 2025
• Study Completion: August 31, 2025
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)