A Trial to Examine the Effects of a Weight Loss Program Emphasizing Protein, Dietary Fiber, and Exercise (30-30-30 Plan)

NCT07789769 | Not Yet Recruiting

• 1 other identifier: MB-2520
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to learn whether following an online weight loss program with specific dietary and exercise goals (the 30-30-30 plan) can help improve weight loss and other markers of health when compared to an online weight loss program on its own.

Conditions

Overweight , Obesity

Outcome Measures

Primary Outcomes (1)

• Body Weight

  Percentage change in body weight

  From week 0 to week 24

Secondary Outcomes (18)

• Body Weight

  From week 0 to week 8

• Body Weight

  From week 0 to week 16

• Waist Circumference

  From week 0 to week 8

• Waist Circumference

  From week 0 to week 16

• Waist Circumference

  From week 0 to week 24

Study Arms (2)

Standard

ACTIVE COMPARATOR

Standard interactive, online weight loss program adapted from the Rx WL program.

Behavioral: Standard

30-30-30 PFE intervention

EXPERIMENTAL

Interactive, online weight loss program adapted from the Rx Weight Loss (Rx WL) program with additional goals to consume ≥30 g protein/meal (P) + ≥30 g fiber/day (F) + ≥30 minutes of daily exercise (E) (30-30-30 PFE intervention).

Behavioral: 30-30-30 PFE Intervention

Interventions

30-30-30 PFE Intervention BEHAVIORAL

Interactive, online weight loss program adapted from the Rx Weight Loss (Rx WL) program with additional goals to consume ≥30 g protein/meal (P) + ≥30 g fiber/day (F) + ≥30 minutes of daily exercise (E).

30-30-30 PFE intervention

Standard BEHAVIORAL

Standard interactive, online weight loss program adapted from the Rx WL program.

Standard

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individual is a male or female and 18 to 69 years of age, inclusive.
• Individual has a self-reported desire to lose weight.
• Individual has a BMI ≥27.0 and ≤45.0 kg/m2.
• Individual has calculated energy needs of ≥1800 kcal/d per the Mifflin-St Jeor Equation, with an adjustment for energy expended in physical activity.
• Individual must be fluent in speaking, reading, and writing in English.
• Individual owns a Bluetooth-compatible smartphone capable of downloading a fitness tracking app, with a camera, and has reliable Wi-Fi connectivity at home.
• Individual is judged by the Investigator to be in generally good health on the basis of medical history and screening assessments.
• Individual is willing and able to undergo the scheduled study procedures, including participating in an interactive, online weight loss program for 6 months, attending virtual meetings, and striving to fulfill dietary and exercise goals.
• Individual understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

You may not qualify if:

• Individual has a laboratory test result of clinical significance based on the judgment of the Principal Investigator or qualified designee.
• Individual is unwilling or unable to make dietary changes or increase physical activity.
• Individual is unable to walk ¼ mile unaided without stopping.
• Individual has a health condition (e.g., chronic pain, orthopedic limitations, heart problems) that would make weight loss or unsupervised exercise unsafe or infeasible. If an individual responds "yes" to any of the questions on the PAR-Q during visit 1, it is up to the Investigator's discretion to determine if unsupervised exercise is safe.
• Individual habitually consumes \>9 g fiber per 1000 kcal per day based on their responses on the fiber intake questionnaire.
• Individual habitually engages in ≥210 minutes per week of moderate-intensity or higher physical activity based on their responses on the Stanford 7-Day Physical Activity Recall (Appendix 3).
• Individual regularly consumes (≥3 times per week) protein supplements, including collagen, within 30 days of visit 1.
• Individual has a fasting blood glucose ≥126 mg/dL at screening or known type 1 or type 2 diabetes mellitus or use of any hypoglycemic medication (e.g., insulin, sodium glucose cotransporter-2 inhibitors, alpha glucosidase inhibitors, biguanides, thiazolidinediones, dipeptidyl peptidase-4 inhibitors, meglitinides, sulfonylureas, glucagon-like peptide-1 (GLP-1) receptor agonists, and GLP-1/glucose-dependent insulinotropic polypeptide inhibitors), except for metformin, within 30 days of visit 1.
• Individual has self-reported or clinically diagnosed bipolar disorder, psychosis, or severe depression.
• Individual has been hospitalized for a psychiatric disorder during the past 12 months.
• Individual has lost ≥5% of their body weight in the previous 6 months.
• Individual has participated in a structured weight loss program (e.g., commercial program) within 30 days prior to visit 1.
• Individual has a cardiac defibrillator or pacemaker.
• Individual has a clinically significant medical condition that, in the opinion of the Investigator, could interfere with the interpretation of the study results. Health conditions may include history or presence of clinically important gastrointestinal (e.g., inflammatory bowel disease, Crohn's disease, colitis, irritable bowel syndrome, celiac disease), cardiac (e.g., angina, bypass surgery, or myocardial infarction within previous 6 months), renal, hepatic, endocrine (e.g., Cushing's disease), pulmonary, biliary, pancreatic, or neurological disorders that may affect the participant's ability to adhere to the study protocol and/or affect study outcomes, in the judgment of the Investigator.
• Daily use of tobacco/nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within 12 months of visit 1.

Sponsors & Collaborators

• Midwest Center for Metabolic and Cardiovascular Research: lead
• National Cattlemen's Beef Association, a contractor to the Beef Checkoff: collaborator

Study Sites (3)

Biofortis Clinical Research

Addison, Illinois, 60101, United States

Location

Illinois Institute of Technology

Chicago, Illinois, 60616, United States

Location

Indiana University

Bloomington, Indiana, 47405, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Liana L Guarneiri, PhD, RDN

  Midwest Biomedical Research

  STUDY DIRECTOR

Central Study Contacts

Caryn G Adams, MPH

CONTACT

6304696600; cwolfe@mbclinicalresearch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 27, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 27, 2026

Record last verified: 2026-08

Locations

US (3)