A Trial to Examine the Effects of a Weight Loss Program Emphasizing Protein, Dietary Fiber, and Exercise (30-30-30 Plan)
A Randomized, Controlled Trial to Examine the Effects of an Online Weight Loss Program Emphasizing Protein, Dietary Fiber, and Exercise (30-30-30 Plan) on Body Weight, Body Composition, and Other Cardiometabolic Risk Factors
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 69 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether adding protein, fiber, and exercise goals to an online weight loss program helps people lose more weight and improve health. The 6-month study is for adults ages 18 to 69 who want to lose weight and meet the study’s health and weight requirements.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are 18 to 69 years old and want to lose weight.
- Your BMI is 27 to 45. BMI is a measure based on your height and weight.
- Your body needs at least 1,800 calories a day, based on the study’s calculation.
- You can speak, read, and write English well.
- You own a smartphone with Bluetooth and a camera that can download a fitness app, and you have reliable Wi-Fi at home.
- The study doctor finds that you are generally in good health.
- You can follow study steps for 6 months, join online meetings, and work toward food and exercise goals.
- You understand the study and sign forms agreeing to join and share needed health information.
Who can't join
- You cannot or will not change your diet or increase activity, cannot walk a quarter mile without help or stopping, or have a health problem that makes weight loss or exercise unsafe.
- You already eat more than 9 grams of fiber per 1,000 calories, do at least 210 minutes of moderate or harder exercise weekly, or used protein supplements at least 3 times weekly in the past 30 days.
- You have diabetes, fasting blood sugar of 126 mg/dL or higher, or used blood sugar medicine other than metformin in the past 30 days.
- You lost at least 5% of your weight in 6 months, joined a structured weight loss program in the past 30 days, had weight loss surgery, or follow an excluded diet, such as vegan, vegetarian, or ketogenic.
- You have certain health problems or test results that may affect safety or results. Examples include blood pressure of 160/100 or higher, a pacemaker or implanted heart shock device, untreated thyroid disease, or certain recent cancers.
- You have a history of an eating disorder, bipolar disorder, psychosis, or severe depression; had a mental health hospital stay in the past year; or have recent illegal drug use or heavy alcohol use.
- You are pregnant, breastfeeding, planning pregnancy, or could become pregnant but will not use approved birth control. You also cannot join if you are allergic or sensitive to study foods.
- Other exclusions include certain medicines or supplements, recent daily nicotine use, certain marijuana or hemp use, recent major injury or surgery, planned surgery, active infection, recent antibiotics, or taking part in another research study.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * 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 body mass index (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. Exclusion Criteria: * 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 Physical Activity Readiness Questionnaire (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. * Use of hemp/marijuana products within 12 months of visit 1. Occasional use (e.g., once or twice a month) within 12 months of visit 1 is allowed but requires at least a 14-day washout prior to visit 2 (week 0) and the participant must be willing to refrain from use during the study. * Individual has uncontrolled hypertension (systolic blood pressure ≥160 millimeters of mercury (mm Hg) and/or diastolic blood pressure ≥100 mm Hg) at screening. * Individual has untreated thyroid disease or unstable use (initiation or change in dose) of thyroid hormone replacement medications within 6 months of visit 1. * Use of any prescription medication with known effects on appetite or weight (e.g., oral steroids, weight loss medications, etc.) within 30 days of visit 1. A stable dose of selective serotonin reuptake inhibitors ≥6 months is allowed. * Unstable use of any supplement known to affect energy metabolism within 30 days of visit 2. * Individual has a history of cancer in the prior 5 years, except non-melanoma skin cancer or carcinoma in situ of the cervix. * Individual has extreme dietary habits (e.g., ketogenic, very high protein, very high fiber, vegan, vegetarian). * Individual has a history of metabolic/bariatric surgery or plans to have any type of surgery during the study. * Individual has a history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) either diagnosed by a health professional or self-reported. * Individual has a history of any major trauma or major surgical event within 2 months of visit 1. * Individual has signs or symptoms of an active infection of clinical significance or has taken antibiotics within 5 days prior to any visit (washout is permitted for re-scheduling of the clinic visit). * Individual has an allergy, sensitivity, or intolerance to any components of the study foods. * Individual is a female who is pregnant, planning to become pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. * Individual has been exposed to any non-registered drug product within 30 days prior to visit 1. * Individual is a participant in another research study. * Individual has a current or recent history (within 12 months prior to screening) or strong potential for illicit drug or excessive alcohol intake defined as \>14 drinks per week (1 drink = 12 ounces (oz.) beer, 5 oz. wine, or 1.5 oz. hard liquor). * Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or puts the person at undue risk.
Study sites (3)
IL
- Biofortis Clinical Research · Addison, IL 60101Gina Castiglione-Berg · Study contact · 6306172000 · gina.castiglione-berg@msxn.comAditi Shah, MD · Principal investigatorMore trials in Addison
- Illinois Institute of Technology · Chicago, IL 60616Chelsea Preiss, MS · Study contact · 3125675308 · cpreiss@illlinoistech.eduIndika Edirisinghe, PhD · Principal investigatorMore trials in Chicago
IN
- Indiana University · Bloomington, IN 47405Karen Sprague · Study contact · 812-855-7643 · kaspragu@iu.eduNana Gletsu-Miller, PhD · Principal investigatorMore trials in Bloomington