mNDPR Diet for Obesity
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Northern Arizona University
Must not be taking: Insulin
Disqualifiers: Weight loss surgeries, Pregnancy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The investigators propose to conduct a randomized controlled trial with a wait-list control to determine efficacy in reducing risk of obesity and related disease in Native American employees of Twin Arrows Casino. Participants will be randomly assigned to the experimental group or the wait-list control. The experimental group will receive a 12-week mNDPR nutrition intervention with culturally relevant materials. Five NAU Masters of Public Health (MPH) students will be trained in Motivational Interviewing and the mNDPR nutrition protocol to serve as Lifestyle Coaches. These students will lead weekly, group-based coaching sessions with up to 15 participants each at Twin Arrows Casino. Participants will be assigned to their designated group based on their availability. The 12 weekly group sessions will be scheduled to accommodate various work shifts (day, night, and swing). The first group session will be 2-hours long to serve as an 'immersion', followed by weekly 1-hour sessions, all led by the Lifestyle Coaches. The Lifestyle Coaches will use Motivational Interviewing techniques to assist participants to develop personal goals. Lifestyle Coaches will also provide nutrition education, specifically using the mNDPR protocol. Participants in the wait-list control will receive the same intervention after the experimental group completes their 12-week intervention. In addition to measures at weeks 0 and 13, a 24-hour diet recall will be conducted in week 26 for the experimental group to explore long-term durability of diet quality changes.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking medications that could increase medical risk or have weight loss as a primary side effect.
What data supports the effectiveness of the mNDPR diet treatment for obesity?
Research suggests that addressing micronutrient deficiencies, which are common in obese individuals, can help manage obesity. Studies show that inadequate intake of certain vitamins and minerals is linked to higher body mass index (BMI) and waist circumference, indicating that a micronutrient-dense diet may be beneficial for weight management.
12345Is the mNDPR Diet for Obesity safe for humans?
The safety of the mNDPR Diet, which focuses on a micronutrient-dense, plant-rich approach, is generally supported by research showing that diets rich in whole grains, vegetables, and fruits are associated with better health outcomes. However, ensuring adequate intake of certain nutrients like vitamin D, calcium, iron, and zinc is important, as these can sometimes be low in plant-rich diets.
46789How is the mNDPR diet treatment for obesity different from other treatments?
The mNDPR diet is unique because it focuses on providing a high intake of essential micronutrients through a plant-rich diet, which may help address common micronutrient deficiencies in obese individuals that are not typically targeted by other treatments. This approach aims to improve overall nutrition and potentially reduce obesity-related health issues by ensuring adequate levels of vitamins and minerals.
1341011Eligibility Criteria
This trial is for self-identified Native American employees of Twin Arrows Casino, aged 21-65 with a BMI over 24, not on weight-loss programs or certain medications. They must have worked there for at least a year and plan to stay another year but can't join if pregnant, planning pregnancy, had specific weight loss surgeries, or cannot attend weekly sessions.Inclusion Criteria
I am between 21 and 65 years old.
I have worked at Navajo Gaming Enterprise for a year and plan to continue working there during the study.
Self-identified Native American employee of Twin Arrows Casino
+3 more
Exclusion Criteria
I have had weight loss surgery, such as gastric bypass or sleeve.
I rely on insulin for my diabetes management.
I can attend weekly group coaching sessions.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive a 12-week mNDPR nutrition intervention with weekly group-based coaching sessions
12 weeks
12 weekly group sessions (in-person)
Follow-up
Participants are monitored for long-term durability of diet quality changes and health measures
26 weeks
Diet recall at week 26, health measures at weeks 13 and 26
Long-term Follow-up
Healthcare utilization data collected to evaluate cost-effectiveness
52 weeks
Participant Groups
The study tests a culturally-tailored diet intervention aimed at reducing obesity risk among participants. It involves random assignment to either an immediate or wait-list group receiving the mNDPR nutrition protocol through weekly coaching sessions by trained students using Motivational Interviewing techniques.
2Treatment groups
Experimental Treatment
Active Control
Group I: Micronutrient-dense plant-rich InterventionExperimental Treatment1 Intervention
The intervention will consist of a 2-hour 'immersion' group session, followed by weekly 1-hour group sessions over the following 11 weeks. Groups of no more than 15 individuals will meet weekly for 12 weeks with a trained Lifestyle Coach. Group sessions, held at the Twin Arrows Casino, will provide participants with instructions, assistance with goal setting, support, encouragement, cooking demonstrations, Casino (workplace) dining tours, and will socially engage with other participants. Participants will be requested to follow the mNDPR nutrition protocol for the first 12 weeks. Each week the participants will use a simple tracking method to self-monitor their daily compliance with the nutrition protocol. Lifestyle Coaches will monitor adherence and verify attendance. Instructional materials discussed each week will provide resources and methods to overcome common barriers to dietary change including (i) meal prepping, (ii) social gatherings, and (iii) family resistance.
Group II: Wait-list ControlActive Control1 Intervention
Participants in the wait-list control group will be requested to maintain their typical eating patterns during a 12-week waiting period, until they are scheduled to start the intervention 13-weeks later.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
PRANDIAL LabFlagstaff, AZ
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Who Is Running the Clinical Trial?
Northern Arizona UniversityLead Sponsor
References
[Micronutrition: a global approach for obese patients]. [2015]Micronutrition is proposed as a global approach for the obese person and aims at satisfying needs in micronutrients through a Mediterranean diet. This diet is associated with a personalized complementation if needed. First of all, a consultation in micronutrition consists of detecting possible deficits (iron, chromium, iodine, vitamins and mineral) with the means of patients history, questionnaires and, if needed, biological measurements. Micronutritional deficits are frequent in obese patients on restrictive diets. The balance in essential fatty acids (omega 3/6) and the content of essential amino acids (tryptophan) are crucial for the obese patients follow-up. Finally, intestinal flora seems to play an important role in the physiopathology in obesity.
Long Term Weight Loss Diets and Obesity Indices: Results of a Network Meta-Analysis. [2022]Scientists have been investigating efficient interventions to prevent and manage obesity. This network meta-analysis (NMA) compared the effect of different diets [moderate macronutrients (MMs), low fat/high carbohydrate (LFHC), high fat/low carbohydrate (HFLC), and usual diet (UD)] on weight, body mass index (BMI), and waist circumference (WC) changes at ≥12 months.
[Relationship between dietary consumption of vitamins and minerals, body mass index, and waist circumference: a population-based study of adults in southern Brazil]. [2018]The study's objective was to investigate the association between inadequate dietary consumption of micronutrients and indicators of general and abdominal obesity. Cross-sectional analysis of the second wave of the EpiFloripa Adults longitudinal study, including 1,222 individuals, aged 22-63 years and residing in Florianópolis, Santa Catarina State, Southern Brazil. Food consumption data was obtained from two 24-hour food recalls, and habitual consumption and prevalence rates of inadequate consumption of calcium, iron, zinc, and vitamins A, C, D, and E were estimated according to the Institute of Medicine and National Research Council guidelines. General obesity was defined based on the body mass index (BMI) values and abdominal obesity was based on waist circumference (WC) values. For most of the micronutrients investigated (calcium and vitamins A, C, D, and E), consumption levels were below the recommendations, with high prevalence of inadequate consumption in the sample as a whole. Only inadequate vitamin C intake was higher among obese individuals (general or abdominal). In addition, there was an inverse association between lower consumption of calcium and iron and higher BMI and WC, and between lower consumption of vitamins A and D and higher WC levels (β = -0.92cm; 95%CI: -1.76; -0.08 and β = -0.69 cm; 95%CI: -1.32; -0.06, respectively), especially in young adults. The study showed an inverse association between inadequate dietary consumption of micronutrients and general and abdominal obesity in a sample of adults in Southern Brazil.
Micronutrient deficiency in obese subjects undergoing low calorie diet. [2022]The prevalence of micronutrient deficiencies is higher in obese individuals compared to normal-weight people, probably because of inadequate eating habits but also due to increased demands among overweight persons, which are underestimated by dietary reference intakes (DRI) intended for the general population. We therefore evaluated the dietary micronutrient intake in obese individuals compared to a reference population and DRI recommendations. Furthermore, we determined the micronutrient status in obese subjects undergoing a standardized DRI-covering low-calorie formula diet to analyze if the DRI meet the micronutrient requirements of obese individuals.
Obesity coexists with malnutrition? Adequacy of food consumption by severely obese patients to dietary reference intake recommendations. [2016]To assess the adequacy of food intake in severely obese patients and describe their main nutritional deficiencies on the basis of Dietary Reference Intakes (DRIs). Patients on a waiting list for bariatric surgery were sequentially recruited from March 2010 to November 2011. All subjects underwent nutritional status assessment (anthropometry, dietary recall and semi-structured interview), socioeconomic evaluation (Brazilian Association of Research Companies criteria) and laboratory testing (glucose/hormone/lipid panel). A total of 77 patients were assessed, 50 of whom (76.6%) were female. Mean age was 44.48 ± 12.55 years. The most common comorbidities were hypertension (72.4%), binge eating disorder (47.4%), type 2 diabetes mellitus (32.9%), sleep apnea (30.3%) and dyslipidemia (18.4%). Macronutrient intake was largely adequate, in view of the high calorie intake. However, some micronutrient deficiencies were present. Only 19.5% of patients had an adequate intake of potassium, 26.0% of calcium, and 66.2% of iron. All subjects consumed more than the minimum recommended intake of sodium, with 98.7% reaching the upper limit. Bcomplex vitamin intake was satisfactory (adequate in >80% of subjects), but lipid-soluble vitamin (A, D, E) intake often fell short of the RDI. The diet of severely obese patients is unbalanced, with high calorie intake paralleled by insufficient micronutrient intake. When these patients are assessed and managed, qualitative dietary changes should be considered in addition to routine caloric restriction.
Nutritional adequacy of diets reported at baseline and during trial years 1-6 by the special intervention and usual care groups in the Multiple Risk Factor Intervention Trial. [2018]This chapter addresses whether a fat-modified diet as implemented by special intervention participants in the Multiple Risk Factor Intervention Trial affected intake of vitamins and minerals, and whether nutritional adequacy was altered by this dietary intervention. Despite likely underreporting of intake, for men in the special intervention group, most mean intakes of 15 micronutrients estimated from 24-h recalls were above established recommended dietary allowances. A few means were slightly below; lowest was zinc at 77% (from 98% at baseline) followed by calcium at 79% (from 102% at baseline). Calculated as nutrient densities (per 1000 kcal), nutrients that were below indexes of nutritional quality (the corresponding standard based on nutrient density) during follow-up, although not reduced below baseline by this measure, were vitamin D, calcium, iron (marginally), and zinc. Analyses by food groups indicated that intake of these nutrients might have been improved by greater replacement of high- and medium-fat dairy products with low-fat dairy products (for vitamin D and calcium) and of high-fat meats with low-fat meats, fish, or poultry (for iron and zinc), or (because iron was adequate) by increasing consumption of vegetables and whole-grain products. The safety of the eating pattern was further confirmed by more favorable micronutrient profiles in men who adhered best to the intervention program, as measured by degree of serum cholesterol reduction and weight loss.
Calcium plus vitamin D3 supplementation facilitated fat loss in overweight and obese college students with very-low calcium consumption: a randomized controlled trial. [2022]Recent evidence suggests that higher calcium and/or vitamin D intake may be associated with lower body weight and better metabolic health. Due to contradictory findings from intervention trials, we investigated the effect of calcium plus vitamin D3 (calcium+D) supplementation on anthropometric and metabolic profiles during energy restriction in healthy, overweight and obese adults with very-low calcium consumption.
In the context of the triple burden of malnutrition: A systematic review of gene-diet interactions and nutritional status. [2022]Genetic background interacts with dietary components to modulate nutritional health status. This study aimed to review the evidence for gene-diet interactions in all forms of malnutrition. A comprehensive systematic literature search was conducted through April 2021 to identify observational and intervention studies reporting the effects of gene-diet interactions in over-nutrition, under-nutrition and micronutrient status. Risk of publication bias was assessed using the Quality Criteria Checklist and a tool specifically designed for gene-diet interaction research. 167 studies from 27 populations were included. The majority of studies investigated single nucleotide polymorphisms (SNPs) in overnutrition (n = 158). Diets rich in whole grains, vegetables, fruits and low in total and saturated fats, such as Mediterranean and DASH diets, showed promising effects for reducing obesity risk among individuals who had higher genetic risk scores for obesity, particularly the risk alleles carriers of FTO rs9939609, rs1121980 and rs1421085. Other SNPs in MC4R, PPARG and APOA5 genes were also commonly studied for interaction with diet on overnutrition though findings were inconclusive. Only limited data were found related to undernutrition (n = 1) and micronutrient status (n = 9). The findings on gene-diet interactions in this review highlight the importance of personalized nutrition, and more research on undernutrition and micronutrient status is warranted.
Prevalence of micronutrient deficiency in popular diet plans. [2021]Research has shown micronutrient deficiency to be scientifically linked to a higher risk of overweight/obesity and other dangerous and debilitating diseases. With more than two-thirds of the U.S. population overweight or obese, and research showing that one-third are on a diet at any given time, a need existed to determine whether current popular diet plans could protect followers from micronutrient deficiency by providing the minimum levels of 27 micronutrients, as determined by the U.S. Food and Drug Administrations (FDA) Reference Daily Intake (RDI) guidelines.
The consumption of micronutrients in relation to calorie intake and risk of insulin resistance. [2023]Adequate dietary intakes of essential micronutrients are critical to prevent insulin resistance (IR)-related diseases. Even though the excess calorie intake linked with obesity is also associated with such diseases, no previous studies evaluated the importance of meeting the Dietary Reference Intake (DRI) of micronutrients in relation to calorie intake in those at risk for developing IR.
Association Between Antioxidant Intake/Status and Obesity: a Systematic Review of Observational Studies. [2018]The global prevalence of obesity has doubled in recent decades. Compelling evidences indicated that obesity was associated with lower concentrations of specific antioxidants which may play a role in the development of obesity-related diseases such as cardiovascular disease. The present review aimed to synthesize the evidence from studies on the association between obesity and antioxidant micronutrients in a systematic manner. Data bases including MEDLINE, Science Direct, and Cochrane were searched from inception to October 2015. Thirty-one articles were reviewed using the MOOSE checklist. Lower concentrations of antioxidants have been reported in obese individuals among age groups worldwide. Circulatory levels of carotenoids, vitamins E and C, as well as zinc, magnesium, and selenium were inversely correlated with obesity and body fat mass. However, studies demonstrated inconsistencies in findings. Lower status of carotenoids, vitamins E and C, zinc, magnesium, and selenium appears to be associated with adiposity. Intervention studies may be needed to establish the causality of these associations.