The 40DTU (40-Day Transformation Unit) is a program designed to assist individuals in weight loss and overall well-being. Founded by Dr. Joseph L. Williams, this process emphasizes a holistic approach, addressing the interconnectedness of mind, body, and spirit. The 40DTU is not just a diet plan, but a comprehensive journey toward lasting change.
The Journey: A Holistic Process, Not Just a Program
Dr. Joseph L. Williams posits that true transformation requires addressing the needs of the whole person - mind, body, and spirit. A program has a start and an ending point; however, a process is something that can be ongoing. Issues with obesity or addictive behaviors often stem from underlying spiritual and emotional issues. Therefore, simply addressing the physical aspect may miss the root cause of the problem. This theory can be applied to any facet of human consciousness.
The Puerto Rican Optimized Mediterranean-like Diet (PROMED)
The Puerto Rican Optimized Mediterranean-like Diet (PROMED) offers a valuable model for culturally tailored interventions. This study, conducted in Puerto Rico, adapted the Mediterranean Diet (MedDiet) to suit the local culture and food systems.
Background on the Mediterranean Diet
Adhering to a Mediterranean Diet (MedDiet) is associated with a healthier cardiometabolic profile. The MedDiet is characterized by mainly consuming plant-based foods, including fiber-rich cereals, fruits, vegetables, olives, nuts, and seeds; consuming legumes, nuts, fish, and eggs as primary sources of protein; using olive oil; and consuming dairy products in moderation. Alcoholic beverages-predominantly wine-are permitted in moderation.
One seminal clinical trial testing the efficacy of the MedDiet on cardiometabolic risk factors was conducted in Spain between 2003 and 2012. The Prevención con Dieta Mediterránea (PREDIMED) was a multicenter, randomized controlled clinical trial that aimed to assess the effects of the MedDiet on primary prevention of CVD. The study randomly assigned participants with a high risk of CVD a MedDiet supplemented with either extra virgin olive oil or mixed nuts (that is, walnuts, hazelnuts, almonds) or a reduced-fat control diet. The trial showed benefits of the MedDiet within 3 mo, with significant reductions in plasma glucose, systolic blood pressure, and the ratio of total cholesterol-to-high-density lipoprotein cholesterol (HDL-C) in both the olive oil group and the nuts group, and C-reactive protein (CRP) in the olive oil group, compared with the control diet. Compared with the control diet, long-term data from PREDIMED showed lower blood pressure and reduced risk of major cardiovascular events and T2D for participants in the olive oil or nuts groups. PREDIMED’s use of olive oil and nuts responds to their status as highly consumed traditional foods in countries bordering the Mediterranean Sea and their high content of healthy fatty acids and antioxidants.
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Adapting the MedDiet for Puerto Rico
Individuals living in the United States (US) territory of Puerto Rico (PR) have high prevalence of cardiometabolic conditions, including an estimated 16%-26% of adults with T2D, 40% with hypertension, and 68% classified with overweight or obesity. Adults in PR have unhealthy dietary patterns characterized by low intake of fruit, vegetables, and whole grains and a high intake of sweets and sugary beverages. Observational studies among Puerto Rican adults suggest that following a Mediterranean-like diet comprised of traditional foods from PR is associated with lower abdominal obesity and body mass index (BMI), less insulin resistance, reduced inflammation, and improved cognitive function.
Multiple agencies and committees, including the US Dietary Guidelines for Americans, the American Heart Association, and the World Health Organization, advocate for including nutrient-dense food and beverage choices that reflect personal and ethnic or cultural preferences. These calls-to-action highlight the need for culturally-tailored programs that improve upon the existing evidence, leverage available food systems, and value cultural traditions of diverse communities. Ethnically-tailored interventions can be more effective than general dietary messages. Thus, reporting the details of a cultural adaptation is essential to inform future processes in other populations.
PROMED Study Design and Methods
The Puerto Rican Optimized Mediterranean-like Diet (PROMED) was a single-site 2-mo parallel two-arm randomized pilot and feasibility trial. The design included an in-person baseline nutritional counseling session among free-living adults (25-65 y) living in PR with at least two cardiometabolic risk factors, followed by text messages with content from the counseling session sent daily for 2 mo (delivery phase) and the same texts repeated daily for two more months (reinforcement phase). Eligible participants in both the control and intervention groups were asked to attend a baseline, 2- and 4-mo visit for clinical measurements and questionnaires. One week after the baseline visit, the intervention group received one 1-h nutritional counseling session for a portion-control MedDiet-like tailored to adults in PR and a supply of vegetable oil and legumes to last for the first 2 mo. The control group received one 1-h nutritional counseling session for a standard portion-control diet and cooking utensils.
All data collection and procedures were conducted at FDI Clinical Research (FDI), an independent research center and medical care facility in San Juan, PR. FDI is associated with multiple research and clinical institutions and a network of primary care clinics across the archipelago of PR to facilitate recruitment. The Institutional Review Boards of Harvard TH Chan School of Public Health (protocol # IRB19-0184) and Ponce Health Sciences University in PR (protocol #1905013193A001) approved this study. The study was registered at clinicaltrials.gov NCT03975556. The study was conducted from July 2019 to June 2021.
Outcome Measures and Data Collection
Similar to a previous study [31], the primary outcome of PROMED was a composite cardiometabolic improvement score representing the summed number of improved cardiometabolic risk factors out of the 10 factors that were part of the eligibility criteria; the score has a plausible range of 0-10. Improvement was defined by clinically-meaningful decreases of 1) waist circumference ≥ 1 cm; 2) BMI ≥ 1 kg/m2; 3) systolic blood pressure ≥ 5 mmHg; 4) diastolic blood pressure ≥ 5 mmHg; 5) plasma glucose ≥ 1 mg/dL; 6) hemoglobin A1c ≥ 0.5%; 7) plasma triglycerides ≥10 mg/dL; 8) total cholesterol ≥ 10 mg/dL; and 9) LDL-C ≥ 10 mg/dL; or an increase of [8] HDL-C ≥ 5 mg/dL. A composite score was selected to account for baseline variability in cardiometabolic risk profiles. Secondary outcomes included changes in the individual cardiometabolic risk factors plus weight, dietary intake, overall diet quality, diet satisfaction, dietary behaviors, and psychosocial factors (e.g., depressive symptoms, stress).
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Interested individuals contacted the study and were screened for potential eligibility using a phone-administered screening questionnaire. If eligibility was probable based on these criteria, the individual was invited to a baseline visit where the research assistants used a scripted guide with clear, concise points to explain the study’s purpose, risks, and benefits, and any answer questions. Participants had the option of having a health proxy in the room during this process. Written informed consent to participate was obtained, including authorization to publish anonymized results as aggregated data.
Exclusion Criteria
Individuals were excluded from the study for several reasons: 1) self-reported physician-diagnosed type 1 or type 2 diabetes or use of diabetes medication or had a measured fasting plasma glucose ≥126 mg/dL (7.0 mmol/L) or hemoglobin A1C ≥ 6.5% (48 mmol/mol) at the baseline visit; 2) reported current pregnancy; 3) reported condition that would influence eating behaviors or nutritional status (e.g., Chron disease, inflammatory bowel disease, celiac disease, liver disease, kidney disease, cancer, diverticulitis, nut allergy, severe food allergies, or aversions); and 4) intolerance or allergies to legumes (that is, beans and nuts) or vegetable oils (that is, soybean, olive, canola). The blood test results of potentially-eligible individuals were received within 1 wk of the baseline visit. The values were used to confirm eligibility. If a person was deemed ineligible based on measured laboratory values, the individual was immediately informed and withdrawn from the study.
Randomization and Study Procedures
Confirmed, eligible, and consented participants were randomly assigned to one of the two study groups (control or intervention) in a 1:1 allocation ratio. These participants were randomized using sex stratification (40% males and 60% females) and permuted blocks with random block sizes. For this randomization scheme, a sequence of block sizes was randomly generated in which allowable blocks were a random mix of sizes 2 or 4 participants. Trained research assistants conducted all visits in a single private room at FDI. Research assistants were bilingual (English and Spanish) and trained in culturally sensitive interviewing, clinical protocols, data collection, data entry, confidentiality, and safety measures. Each clinical visit lasted ∼2 h. The counseling session lasted 1 h. Participants were compensated for their time up to $150, such that they received $50 at each of the three examination visits, with no monetary incentive at the counseling session. At the counseling session, participants received a bag with food (intervention group) or cooking utensils (control group). Participants were allowed to pause or terminate the interviews at any time. In such case, the participant was contacted up to five times within the subsequent 14 d to complete the pending questionnaires or measurements. Participants remained enrolled in the study for its duration (4 mo) unless they actively left the study, had a new ineligibility factor, or lost contact.
Data Collection Instruments
The research assistant administered a questionnaire that asked about age, sex-at-birth, household income, educational attainment, employment, household composition, menopausal status, healthcare services, medical diagnoses, family history of major diseases, food security and assistance, smoking status, alcohol use, sleep quantity and quality, moderate and vigorous physical activity, and satisfaction and engagement with the program. A perceived stress scale captured feelings of stress within the previous month. Depressive symptomatology was captured using the Center for Epidemiologic Studies Depression Scale. The University of California-Los Angeles Loneliness 3-item scale measured overall loneliness.
Dietary Assessment
Diet was assessed at the clinic visits using the Spanish version of a brief diet quality index with questions on frequency and amount of intake in the past month of 18 major Mediterranean food groups, after minor linguistic and cultural adaptations. Daily intake of one serving (1 s/d) of bread, vegetable, fruit, yogurt/milk, rice/pasta, olive/corn/sunflower oil, alcoholic beverages, and breakfast cereal was assessed. Three points were given for intake >1 s/d, two points for 1 s/d, and one point for <1 s/d. Weekly servings of meat, sausage, cheese, pastry/sweet, butter/lard, other oils, or fast foods were assessed as 1/wk, 4-6/wks, or >6/wks; these frequencies were given three points, two points, and one point, respectively. Fish, legumes, and nuts were assessed as >3/wks, 2-3/wks, and <2/wks, which were scored three points, 2 points, and two points, respectively. Food group points were summed to generate a total score ranging from 18 (no adherence to the MedDiet) to 54 (optimal adherence). A short food frequency questionnaire captured the frequency of consumption of 33 major food groups during the previous month. These questionnaires were supplemented with questions about specific types and amounts of legumes and vegetable oils intake during the previous month to gauge further adherence. Compliance to the intervention recommendations was defined as reporting consumption of one serving of vegetable oil intake >1 times/d and of legumes >3 times/wk. Compliance to the control recommendations was defined as reporting consumption of one serving of meat (lean beef, pork, or poultry) >6 times/wk. These foods were emphasized in the corresponding group’s counseling session. Diet satisfaction was measured with the 45-item Diet Satisfaction Questionnaire that includes seven scales to assess healthy lifestyle, cost, convenience, family dynamics, preoccupation with food, negative aspects, and planning and preparation. Emotional and restrictive eating behaviors were captured with the Three-Factor Eating Questionnaire.
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Physical Measurements and Blood Sample Collection
Participants were instructed to wear light clothing and remove any outerwear, stand with feet close together, arms at the side, and body weight evenly distributed, and relax and breathe normally; measurements were taken at the end of a normal expiration. Weight was measured using a Detecto SLIMTALKXL scale to the nearest 0.1 kg (Cardinal/Detecto). Height was measured using a Seca 213 stadiometer to the nearest 1 mm (Seca). With the participant seated for 5 min and feet flat on the floor, blood pressure and pulse were measured with a clinically-validated Omron 10 Series Upper Arm Monitor Model BP7450 (OMRON Healthcare) at either arm, at the beginning, midpoint, and end of the visit. Participants were asked to refrain from consuming food or beverages other than water for 12 h before the scheduled appointment; fasting status was confirmed by the participant before the blood draw. Fasting blood samples were obtained via venipuncture by a licensed nurse following standardized protocols and safety procedures; sampling tubes for glucose analysis contained antiglycolytic agents. Plasma was separated within 2 h of the blood draw at FDI in a refrigerated centrifuge. Samples were refrigerated or frozen until collected for laboratory analysis at the CLIA-approved Toledo Laboratory. Blood samples were analyzed in the Alinity-c Systems (Abbott) for lipid panel using enzymatic reagents for total cholesterol, the glycerol phosphate oxidase method for plasma triglycerides, an accelerator selective detergent for HDL-C, the hex…
Key Components of the 40DTU
While specific details of the 40DTU plan are not provided, we can infer key components based on Dr. Williams' philosophy and the PROMED study:
- Holistic Approach: Addressing mind, body, and spirit.
- Culturally Tailored Diet: Adapting dietary recommendations to individual preferences and cultural norms.
- Nutritional Counseling: Providing guidance and education on healthy eating habits.
- Ongoing Support: Reinforcing positive behaviors through continuous encouragement and follow-up.