Objective:To develop and test the feasibility of a whole-systems lifestyle intervention for obesity treatment based on the practices of Ayurvedic medicine/ Yoga therapy.Design:A pre-post weight loss intervention pilot study using conventional and Ayurvedic diagnosis inclusion criteria, tailored treatment within a standardized treatment algorithm, and standardized data collection instruments for collecting Ayurvedic outcomes.Participants:A convenience sample of overweight/obese adult community members from Tucson, Arizona interested in a “holistic weight loss program” and meeting predetermined inclusion/exclusion criteria.Intervention:A comprehensive diet, activity, and lifestyle modification program based on principles of Ayurvedic medicine/yoga therapy with significant self-monitoring of lifestyle behaviors. The 3-month program was designed to change eating and activity patterns and to improve self-efficacy, quality of life, well-being, vitality, and self-awareness around food choices, stress management, and barriers to weight loss.Primary Outcome Measures:Changes in body weight, body mass index; body fat percentage, fat/lean mass, waist/hip circumference and ratio, and blood pressure.Secondary Outcome Measures:Diet and exercise self-efficacy scales; perceived stress scale; visual analog scales (VAS) of energy, appetite, stress, quality of life, well-being, and program satisfaction at all time points.Results:Twenty-two adults attended an in-person Ayurvedic screening; 17 initiated the intervention, and 12 completed the 3-month intervention. Twelve completed follow-up at 6 months and 11 completed follow-up at 9 months. Mean weight loss at 3 months was 3.54 kg (SD 4.76); 6 months: 4.63 kg, (SD 6.23) and 9 months: 5.9 kg (SD 8.52). Self-report of program satisfaction was more than 90% at all time points.Conclusions:An Ayurveda-/yoga-based lifestyle modification program is an acceptable and feasible approach to weight management. Data collection, including self-monitoring and conventional and Ayurvedic outcomes, did not unduly burden participants, with attrition similar to that of other weight loss studies.
Objectives: This scoping review evaluates two decades of methodological advances made by “whole systems research” (WSR) pioneers in the fields of traditional, complementary, and integrative medicine (TCIM). Rooted in critiques of the classical randomized controlled trial (RCT)'s suitability for evaluating holistic, complex TCIM interventions, WSR centralizes the principle of “model validity,” representing a “fit” between research design and therapeutic paradigm. Design: In consultation with field experts, 41 clinical research exemplars were selected for review from across 13 TCIM disciplines, with the aim of mapping the range and methodological characteristics of WSR studies. Using an analytic charting approach, these studies' primary and secondary features are characterized with reference to three focal areas: research method, intervention design, and outcome assessment. Results: The reviewed WSR exemplars investigate a wide range of multimodal and multicomponent TCIM interventions, typified by wellness-geared, multitarget, and multimorbid therapeutic aims. Most studies include a behavioral focus, at times in multidisciplinary or team-based contexts. Treatments are variously individualized, often with reference to “dual” (biomedical and paradigm-specific) diagnoses. Prospective and retrospective study designs substantially reflect established biomedical research methods. Pragmatic, randomized, open label comparative effectiveness designs with “usual care” comparators are most widely used, at times with factorial treatment arms. Only two studies adopt a double-blind, placebo-controlled RCT format. Some cohort-based controlled trials engage nonrandomized allocation strategies (e.g., matched controls, preference-based assignment, and minimization); other key designs include single-cohort pre–post studies, modified n-of-1 series, case series, case report, and ethnography. Mixed methods designs (i.e., qualitative research and economic evaluations) are evident in about one-third of exemplars. Primary and secondary outcomes are predominantly assessed, at multiple intervals, through patient-reported measures for symptom severity, quality of life/wellness, and/or treatment satisfaction; some studies concurrently evaluate objective outcomes. Conclusions: Aligned with trends emphasizing “fit-for-purpose” research designs to study the “real-world” effectiveness of complex, personalized clinical interventions, WSR has emerged as a maturing scholarly discipline. The field is distinguished by its patient-centered salutogenic focus and engagement with nonbiomedical diagnostic and treatment frameworks. The rigorous pursuit of model validity may be further advanced by emphasizing complex analytic models, paradigm-specific outcome assessment, inter-rater reliability, and ethnographically informed designs. Policy makers and funders seeking to support best practices in TCIM research may refer to this review ...
Objectives: To determine the feasibility and acceptability of an Ayurveda/Yoga intervention for weight loss, using dual-diagnosis inclusion criteria, dual-paradigm outcomes, and a semistandardized protocol with tailoring according to the Ayurvedic constitution/imbalance profile of each participant. Design: Seventeen participants enrolled in a weekly intervention for 3 months. Outcome measurements were performed at baseline, postintervention, and 3 and 6 months follow-up. Setting: The intervention was conducted through the University of Arizona, Department of Family and Community Medicine from April through December 2012. Subjects: Participants included 2 men and 15 women recruited from the community of Tucson, AZ using flyers and hospital message boards. Seventeen enrolled and 12 participants provided complete follow-up data. Intervention: Participants met with an Ayurvedic practitioner twice monthly (six times) and followed semistandardized dietary guidelines with individual tailoring to address relevant psychophysiological imbalances obstructing weight loss and a standardized protocol of therapeutic yoga classes three times weekly with recommended home practice of two to four additional sessions. Outcome measures: Primary outcome was weight loss. Other biomedical outcomes included body mass index, body fat percentage, waist and hip circumference, waist to hip ratio, and blood pressure. Unique instruments were designed to collect data on outcomes associated with the Ayurvedic medical paradigm, including dietary changes by food qualities, mood/affect, relationships, and changes in Ayurvedic imbalance profiles. Results: Participants lost an average of 3.5 kg during the 3-month intervention. Weight loss at 3 and 6 months postintervention increased to an average of 5.6 kg and 5.9 kg, respectively. Participants who lost 3% of their body weight during the 12 week intervention, lost on average an additional 3% during the follow-up period. Psychosocial outcomes also improved. No additional services were provided to participants during the followup period. Conclusions: A whole-systems Ayurvedic medicine and Yoga therapy approach provides a feasible promising noninvasive low-cost alternative to traditional weight loss interventions with potential added benefits associated with sustainable holistic lifestyle modification and positive psychosocial changes.
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