Changes in weight and physical function for older African American women in Take Off Pounds Sensibly (TOPS): Study protocol for a randomized clinical trial.
Nia S Mitchell, Rebecca North, Anna Hung, Kathryn N Porter Starr, Connie W Bales, Cynthia J Coffman
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引用次数: 0
Abstract
Background: Obesity and frailty are positively linked. Compared to other groups, older African American women have the highest rates of both obesity and frailty. Several academic weight loss interventions have shown that older adults can lose weight and improve physical function through diet and exercise. However, these programs do not have infrastructure for dissemination. Take Off Pounds Sensibly (TOPS) is a peer-led, community-based weight loss program with TOPS has a nationwide infrastructure that facilitates dissemination. Retrospective analyses showed that TOPS participants could lose a clinically significant amount of weight and maintain the loss for up to 7 years. This study will evaluate how TOPS participation affects weight change; physical function; cardiovascular disease risk factors; quality of life; and healthcare utilization among older African American women.
Methods: We are recruiting 104 older African American women aged ≥55 years with a BMI ≥ 27 kg/m2 to participate in a 6-month randomized wait-list controlled trial where TOPS is facilitated by a dietitian in weekly meetings. The primary goal of the intervention is for participants to lose at least 5 % of their initial weight. Outcomes will be collected at study visits at baseline, 3 months, and 6 months.
Discussion: If successful, this study will show that the TOPS program would be an option to treat excess weight and poor physical function among older African American women.
期刊介绍:
Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.