Body Composition Changes Resulting from Nutrition Supplementation and Nutrition Education: Results from 2 × 2 Factorial Trial of 600 Rural Indian Women Living with HIV/AIDS

Abstract

Abstract Objectives People living with HIV/AIDS are at increased risk of nutritional deficiencies. Loss of lean muscle mass has been associated with a more rapid decline of immune function and increased risk of mortality among individuals suffering from HIV. Our objectives were to evaluate the relative contributions of nutrition supplementation and nutrition education on body composition outcomes using a cluster randomized factorial trial among 600 women living with HIV/AIDS in rural Andhra Pradesh, India. Methods We conducted a prospective cluster randomized controlled 2 × 2 factorial design to assess impacts of nutritional education and nutritional supplementation over a six-month period, with follow up at six, twelve and eighteen months post enrollment. Study protocols were approved by Human Subjects Committees at the Universities of California at Los Angeles, Irvine, and San Francisco and the Ministry of Health in India. Interventions were delivered in the Nellore and Prakasam regions of Andhra Pradesh by trained lay village women, Ashas (Accredited Social Health Activists). Interventions included: usual supportive care provided by Ashas; 2) Asha Support plus Nutrition education; 3) Asha support plus Nutrition supplementation; and, 4) Asha support plus Nutrition education plus Nutrition supplementation. We measured body composition using a Bioimpedance Analyzer Model 310e. All data was analyzed using SAS 9.4. Results Mixed models evaluated change in lean muscle mass from baseline as the primary outcome, and fat weight, overall weight and BMI changes as secondary outcomes. Change in muscle mass from baseline was significantly associated with nutrition supplementation (P = 0.001), nutrition education (P = 0.01), with a significant interaction (P = 0.03) for the combined nutrition supplementation and education term. Using the same factorial structure, nutrition supplementation and education were independently associated with changes in BMI and fat mass. Conclusions Interventions that target nutrition may be an important approach to improving the physiologic response to HIV. We observed significant increases in muscle mass resulting from independent contributions of nutrition education and nutrition supplementation, as well as their combined contribution. Funding Sources NIMH R01MH098728.