Calorie Restriction in Overweight Seniors: Response of Older Adults to a Dieting Study: The CROSSROADS Randomized Controlled Clinical Trial

Abstract

We conducted a study designed to evaluate whether the benefits of intentional weight loss exceed the potential risks in a group of community-dwelling, obese, older adults who were at increased risk for cardiometabolic disease. The CROSSROADS trial used a prospective randomized controlled design to compare the effects of changes in diet composition alone or combined with weight loss with an exercise only control intervention on body composition and adipose tissue deposition (Specific Aim #1: To compare the effects of changes in diet composition alone or combined with weight loss with an exercise only control intervention on body composition, namely visceral adipose tissue (VAT)), cardiometabolic disease risk (Specific Aim #2: To compare the effects of a change in diet composition alone or combined with weight loss with an exercise only control intervention on cardiometabolic disease risk), functional status and quality of life (Specific Aim #3: To compare the effects of a change in diet composition alone or combined with weight loss with an exercise only control intervention on functional status and quality of life). Participants were randomly assigned to one of three groups: Exercise Only (Control) Intervention, Exercise + Diet Quality + Weight Maintenance Intervention, or Exercise + Diet Quality + Weight Loss Intervention. CROSSROADS utilized a lifestyle intervention approach consisting of exercise, dietary, and behavioral components. The development and implementation of the CROSSROADS protocol, including a description of the methodology, detailing specific elements of the lifestyle intervention, assurances of treatment fidelity, and participant retention; outcome measures and adverse event monitoring; as well as unique data management features of the trial results, are presented in this article.

Effects of Calorie Restriction in Obese Older Adults: The CROSSROADS Randomized Controlled Trial

“…Additionally, CROSSROADS has been registered in ClinicalTrials.gov (Registration Number Identifier: NCT00955903). A comprehensive description of the methodology following recommendations of the CONSORT Statement for reporting of randomized controlled trials has been published previously (19).…”

“…Potential participants had to be at least 65 years old; be weight stable and obese (body mass index of 30-40 kg/m 2 ); and prescribed at least one oral medication for control of lipids, blood pressure, and/or blood glucose, resulting in adequate control of the risk factor (eg, blood pressure < 160/100 mm Hg). Volunteers were excluded from participation during a series of one telephone and three in-person screening visits if they had significant medical, psychiatric, or physical limitations that would prevent adoption of the lifestyle recommendations or ongoing treatments that would independently affect body weight and composition (19).…”

“…Detailed methodology has been previously published (19); key measures are briefly described here. Body weight was measured in light clothing on calibrated electronic scales to the nearest 0.1 pound and converted to kilograms.…”

“…Body weight was measured in light clothing on calibrated electronic scales to the nearest 0.1 pound and converted to kilograms. The primary study outcome was change in VAT at 1 year measured by MRI on a 3-Tesla Philips Achieva system using previously described techniques (19). Other MRI body composition outcomes of interest included abdominal subcutaneous adipose tissue (SAT), thigh skeletal muscle, and thigh SAT volumes.…”

Time-restricted feeding reduces adiposity in mice fed a high-fat diet

“…Prevention of obesity can attenuate health problems, including those associated with metabolic syndrome [12]. Current intervention strategies to alleviate obesity and its associated complications focus on lifestyle interventions including reducing energy intake and increasing energy expenditure by physical exercise [13,14]. Successful initial and long-term maintenance of weight loss by dietary changes is hampered by the need for behavioral adherence to food choices, portion sizes, and participation in physical exercise.…”