NCT07789769尚未招募不适用
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
Midwest Center for Metabolic and Cardiovascular Research3 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2026年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 试验地点
- 3
- 主要终点
- Body Weight
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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/m
- •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.
排除标准
- •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
- •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
- •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
- •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
- •Use of hemp/marijuana products within 12 months of visit
- •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
- •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
- •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
- •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
- •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
- •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.
研究组 & 干预措施
Standard
Active Comparator
Standard interactive, online weight loss program adapted from the Rx Weight Loss (WL) program.
干预措施: Standard (Behavioral)
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).
干预措施: 30-30-30 PFE Intervention (Behavioral)
结局指标
主要结局
Body Weight
时间窗: From week 0 to week 24
Percentage change in body weight
次要结局
- 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)
- Body composition(From week 0 to week 24)
- Fasting levels of lipoprotein lipids(From week 0 to week 8)
- Fasting levels of lipoprotein lipids(From week 0 to week 16)
- Fasting levels of lipoprotein lipids(From week 0 to week 24)
- Fasting markers of glycemia(From week 0 to week 8)
- Fasting markers of glycemia(From week 0 to week 16)
- Fasting markers of glycemia(From week 0 to week 24)
- Composite measure of biomarkers of inflammation(From week 0 to week 8)
- Composite measure of biomarkers of inflammation(From week 0 to week 16)
- Composite measure of biomarkers of inflammation(From week 0 to week 24)
- Seated, resting systolic and diastolic blood pressures(From week 0 to week 8)
- Seated, resting systolic and diastolic blood pressures(From week 0 to week 16)
- Seated, resting systolic and diastolic blood pressures(From week 0 to week 24)
研究者
研究点 (3)
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