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Long-term effects of randomization to a weight loss intervention in older adults: a pilot study [with consumer summary]
Houston DK, Miller ME, Kitzman DW, Rejeski WJ, Messier SP, Lyles MF, Kritchevsky SB, Nicklas BJ
Journal of Nutrition in Gerontology and Geriatrics 2019 Jan-Mar;38(1):83-99
clinical trial
5/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

Randomized, controlled trials (RCTs) show intentional weight loss improves body composition and physical function in older adults; however, the long-term benefits (and risks) are unknown. We conducted a pilot study to assess the feasibility of recalling prior RCT participants to examine the long-term effects of intentional weight loss on body composition and physical function. A weighted, random sample of 60 older adults who were randomized to caloric restriction plus exercise (CR+EX) or exercise (EX) only in 5 prior RCTs (mean age at randomization, 67.3 years; 69% women, 80% white) were invited to participate. Follow-up was obtained on 89% (42 clinic visits, 10 phone interviews, 1 death) an average of 3.5 years (range 2.2 to 5.8 years) after RCT completion. Despite greater weight, fat and lean mass loss during the RCT (mean difference in change (95% CI) -4.19 (-7.52 to -0.86), -2.75 (-5.10 to -0.40), and -2.32 (-3.69 to -0.95) kg, respectively) in those randomized to CR+EX, long-term changes in weight (2.05 (-2.35 to 6.45) kg) and body composition (1.80 (-1.56 to 5.17) and 0.03 (-2.20 to 2.26) kg for fat and lean mass, respectively) from baseline and physical function at long-term follow-up (mean difference in 400-m walk and SPPB (95% CI) 23.2 (-19.3 to 65.6) sec and -0.03 (-1.02 to 0.96) points, respectively) were similar in CR+EX and EX only. Although improvements in weight and body composition following intentional weight loss may not be sustained long-term, physical function does not appear to be negatively impacted. A larger study is needed to confirm these results.

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