The PROMOTE study (High-protein and resistance-training combination in overweight and obesity) for short-term weight loss and long-term weight maintenance for Chinese people: a protocol for a pilot randomized controlled trial.

Department of Health Statistics, Shaanxi Key Laboratory of Free Radical Biology and Medicine and the Ministry of Education Key Lab of Hazard Assessment and Control in Special Operational Environment, School of Public Health, Air Force Medical University of PLA, Changle West Road No. 169, Xi'an, 710032, Shaanxi, China. Department of Endocrinology, Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science, No. 136, Jingzhou Street, Xiangyang, 441021, Hubei, China. Department of Endocrinology, 3201 Hospital of Xi'an Jiao tong University Health Science Center, 783 Tianhan Road, Hanzhong, 723000, Shaanxi, China. Department of Clinical Nutrition, Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science, No. 136, Jingzhou Street, Xiangyang City, 441021, Hubei, China. Department of Endocrinology, Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science, No. 136, Jingzhou Street, Xiangyang, 441021, Hubei, China. linggao048@sina.com. Department of Health Statistics, Shaanxi Key Laboratory of Free Radical Biology and Medicine and the Ministry of Education Key Lab of Hazard Assessment and Control in Special Operational Environment, School of Public Health, Air Force Medical University of PLA, Changle West Road No. 169, Xi'an, 710032, Shaanxi, China. shanglei@fmmu.edu.cn.

Trials. 2020;(1):47
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Abstract

BACKGROUND It is very important for clinicians and dieticians to explore reasonable weight management strategies for obese people that address both short-term weight loss and subsequent weight maintenance. We hypothesized that resistance training combined with a high-protein diet would result in similar short-term weight loss but better long-term weight maintenance than either a conventional low-fat diet control or a high-protein diet alone. METHODS/DESIGN This is an 8-week randomized parallel controlled trial followed by a 24-week observational follow-up study. A 48-week supplementary follow-up study will be carried out if necessary. The study will be conducted between June 2019 and October 2020. The 90 overweight or obese participants will be randomly assigned to the conventional low-fat diet group, the high-protein diet group and the high-protein diet and resistance training combination group. Primary outcomes are body weight change at week 8 and week 24 compared with the baseline level. DISCUSSION High-quality research on the effect of a high-protein diet combined resistance training on weight loss and weight maintenance is limited in the Chinese population. Our study will provide a basis for obesity management in China and will promote the development of exercise- and diet-related studies. TRIAL REGISTRATION Chinese Clinical Trial Registry, ChiCTR1900023841. Registered on 14 June 2019.