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Prescribed exercise to Reduce Recidivism After Weight Loss-Pilot (PREVAIL-P): Design, methods and rationale.

ABSTRACT: Clinically significant weight loss is associated with health benefits for overweight and obese adults. Participation in adequate amounts of physical activity is critical for weight maintenance. However, the recommended amount of physical activity needed to promote weight maintenance is based primarily on retrospective studies that quantified physical activity levels through questionnaires which tend to overestimate physical activity levels. In addition, the present literature has provided little data on the impact of these physical activity levels on cardiovascular and diabetes risk factors, which may have equal or more clinical importance than weight changes. The Prescribed Exercise to Reduce Recidivism After Weight Loss-Pilot (PREVAIL-P) study will evaluate the effect of aerobic exercise training amount on weight maintenance following clinically significant weight loss in overweight and obese adults (BMI 25-40 kg/m²) age 30-65 years. Participants (N = 39) will complete a 10-week OPTIFAST® weight loss program with supervised aerobic exercise training. Individuals who achieve ≥7% weight loss from baseline will be subsequently randomized to levels of aerobic training consistent with physical activity recommendations (PA-REC) or weight maintenance recommendations (WM-REC) for 18 additional weeks. The primary outcome of the PREVAIL-P study will be change in weight from the completion of OPTIFAST® program to the end of the study. Notable secondary measures include changes in clinically relevant cardiometabolic risk factors between study groups (e.g. blood lipids concentrations, oral glucose tolerance, arterial stiffness). This pilot study will be used to estimate the effect sizes needed for a randomized controlled trial on this topic.

SUBMITTER: Swift DL

PROVIDER: S-EPMC7848432 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature

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Prescribed exercise to Reduce Recidivism After Weight Loss-Pilot (PREVAIL-P): Design, methods and rationale.

Swift Damon L DL McGee Joshua E JE Huff Anna C AC Clunan Marie C MC Gniewek Nicole R NR Brown Taylor T TT Osborne Briceida G BG Bucher Colleen C Tanner Charles J CJ Barefoot Savanna G SG Brophy Patricia P Clark Angela A Dubis Gabriel S GS Martin Corby K CK Beyl Robbie A RA Houmard Joseph A JA Carels Robert A RA Pories Walter W Matarese Laura E LE

Contemporary clinical trials communications 20210120

Clinically significant weight loss is associated with health benefits for overweight and obese adults. Participation in adequate amounts of physical activity is critical for weight maintenance. However, the recommended amount of physical activity needed to promote weight maintenance is based primarily on retrospective studies that quantified physical activity levels through questionnaires which tend to overestimate physical activity levels. In addition, the present literature has provided little ...[more]

PMID: 33553797

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Project description:Background and study aims In the UK, 42,000 people each year are diagnosed with bowel cancer. It is the fourth most common cancer. Surgery to remove the cancer is the best treatment. However, it has a risk of complications, which is doubled for people who are overweight/obese. Patients experiencing complications recover more slowly, stay in the hospital longer and need more care. This isn’t good for patients or the NHS. Physical fitness and well-controlled blood sugar are linked with fewer complications from surgery. For people who are overweight, weight loss improves both of these factors so that it may reduce complications. One reliable way to lose a meaningful amount of weight in the short period before surgery (3-4 weeks) is through a low-calorie diet programme: eating only special nutritious soups and shakes (880 calories/day) that have all the necessary vitamins. With weekly support from a dietitian, most people succeed. Typically, people lose 5% of their weight within 20 days. The NHS uses a version of this programme to treat type 2 diabetes. In small-scale studies, patients with cancer who are overweight have been willing and able to take part in less intensive weight management programmes before surgery but lose little weight. However, the period before bowel cancer surgery is associated with feelings of uncertainty and anxiety, so it is unclear if patients can follow a more intensive programme. Who can participate? To start to find out if this treatment is in the best interests of patients’ physical and mental health, we will recruit 72 overweight patients awaiting bowel cancer surgery What does the study involve? Half of the participants will be randomly allocated to continue with their usual care and half will be offered the weight loss programme. We will see whether enough patients are willing to take part, lose weight, and return for follow-up visits. We will monitor complications for 30 days after surgery and any reduction in muscle mass due to the weight loss. We will interview patients about their experiences. This information will tell us if a full trial is worthwhile to test whether this programme can reduce complications from surgery, improve outcomes for people with bowel cancer, and if the financial costs are likely to be worth the benefits. It will also help us refine the treatment plans according to patient feedback. The researchers discussed the study with seven patients and public representatives (PPI). They thought it was a critical study and the team included their suggestions for making it easier for patients to join the trial, stick to the programme, and attend visits. The research team will work with the PPI throughout the trial.

Project description:ObjectivesTo examine the relationships between plasma and tissue markers of systemic and vascular inflammation and obesity and insulin resistance and determine the effects of aerobic exercise training plus weight loss (AEX+WL) and weight loss (WL) alone on these biomarkers.DesignProspective controlled study.SettingVeterans Affairs Medical Center and University research setting.ParticipantsOverweight and obese sedentary postmenopausal women (N = 77).InterventionsSix months, 3 d/wk AEX+WL (n = 37) or WL (n = 40).MeasurementsTotal-body dual-energy X-ray absorptiometry, abdominal computed tomography, hyperinsulinemic-euglycemic clamps (a criterion standard method of assessing insulin sensitivity), adipose tissue biopsies (n = 28), and blood for homeostasis model assessment-insulin resistance, and soluble forms of intracellular adhesion molecule 1 (sICAM-1) and vascular cell adhesion molecule 1 (sVCAM-1), C-reactive protein (CRP), and serum amyloid A (SAA).ResultsBody weight (P < .001), percentage of fat (P < .001), visceral fat (P < .005), triglyceride levels (P < .001), and systolic blood pressure decreased comparably after WL and AEX+WL (P = .04). Maximal oxygen consumption increased 16% after AEX+WL (P < .001). Insulin resistance decreased in both groups (P = .005). Glucose utilization according to the clamp increased 10% (P = .04) with AEX+WL and 8% with WL (P = .07). AEX+WL decreased CRP by 29% (P < .001) and WL by 21% (P = .02). SAA levels decreased twice as much after AEX+WL (-19%, P = .02) as after WL (-9%, P = .08). Plasma sICAM-1 and sVCAM-1 levels did not change, but women with the greatest reduction in plasma sICAM-1 levels had the greatest reductions in fasting glucose (P = .02), insulin (P = .02), and insulin resistance (P = .004). Gluteal ICAM messenger ribonucleic acid levels decreased 27% after AEX+WL (P = .02) and did not change after WL.ConclusionObesity and insulin resistance worsen markers of systemic and vascular inflammation. A reduction in plasma sICAM-1 is important to improve insulin sensitivity. CRP, SAA, and tissue ICAM decrease with exercise and weight loss, suggesting that exercise training is a necessary component of lifestyle modification in obese postmenopausal women.

Project description:BackgroundPhysical activity is a critical component of lifestyle interventions to reduce body weight and maintain weight loss. The goal of this study was to examine the motivations to exercise in young men following a 5-month residential weight loss programme conducted in the Singapore military as part of National Service.MethodsWe conducted a sequential mixed methods study starting with three focus groups comprising 21 programme instructors. Fifteen former programme participants aged 20.8 years (±1.4) with an average body mass index (BMI) of 29.3 kg/m2 (±4.6) were interviewed in-depth over a total duration of 9 h. Another 487 current programme participants aged 20.8 years (±1.1), BMI 27.1 kg/m2 (±2.6), completed a survey on weight loss, physical fitness, and motivations to exercise using the Behaviours Regulating Exercise Questionnaire (BREQ-3). Qualitative data was coded thematically using the six constructs of exercise motivation described by self-determination theory: amotivation, external, introjected, identified and integrated regulation and intrinsic motivation. Quotes from interviewees were cross-tabulated according to their weight maintenance trajectories. BREQ-3 responses were analysed according to initial body mass index (BMI), percentage weight loss and fitness.ResultsOver the course of the residential programme interview and survey participants experienced an average weight loss of 15.6 kg (±6.5) and 13.0 kg (±5.4) respectively. Among the fifteen interviewees seven had gained no more than 34% of initial weight loss 6 months after completing the programme while another eight had gained more than 51%. We elicited three key themes from the data: (1) Barriers to exercise; (2) diminishing extrinsic motivation; and (3) unidentified exercise benefits. The integration of findings uncovered reinforcing motivational patterns in the areas of health, fitness, camaraderie and identified regulation. Narratives of self-acceptance and shift-work environments gave rise to potentially deleterious motivational patterns. Our findings suggest that successful transition from a residential programme to independent weight management requires a more deliberate pivot from predominantly extrinsic to intrinsic motivational approaches.ConclusionResidential programmes such as the one investigated here, should develop a deliberate transition strategy, replace weight loss targets with physical performance goals and promote sports that are appropriate for young men affected by overweight and obesity.

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Prescribed exercise to Reduce Recidivism After Weight Loss-Pilot (PREVAIL-P): Design, methods and rationale.

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Prescribed exercise to Reduce Recidivism After Weight Loss-Pilot (PREVAIL-P): Design, methods and rationale.

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