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Brief formula low‐energy‐diet for relapse management during weight loss maintenance in the Diabetes Remission Clinical Trial (DiRECT)
Author(s) -
Brosnahan Naomi,
Leslie Wilma,
McCombie Louise,
Barnes Alison,
Thom George,
McConnachie Alex,
Messow Claudia Martina,
Sattar Naveed,
Taylor Roy,
Lean Michael E. J.
Publication year - 2021
Publication title -
journal of human nutrition and dietetics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.951
H-Index - 70
eISSN - 1365-277X
pISSN - 0952-3871
DOI - 10.1111/jhn.12839
Subject(s) - medicine , weight loss , diabetes mellitus , type 2 diabetes , body mass index , post hoc analysis , post hoc , clinical trial , obesity , body weight , weight management , gastroenterology , endocrinology
Background Weight loss maintenance (WLM) is critical for sustaining type 2 diabetes (T2D) remission, but poorly evidenced. We evaluated brief return to formula low‐energy‐diet (LED) as relapse treatments (RTs) during the WLM phase of the Diabetes Remission Clinical Trial (DiRECT). Methods This post‐hoc evaluation included all participants commencing the WLM phase of DiRECT. The protocol offered RT when regain of >2 kg occurred. Results In total, 123/149 (83%) DiRECT intervention participants commenced the WLM phase after 26 (17%) had withdrawn prior to the WLM phase. Most participants [99/123 (80%)] regained >2 kg during the WLM phase, among whom 60/99 (61%) were recorded as using RT and 39/99 (39%) not using any RT. At baseline, RT users had a higher mean (SD) body mass index [35.8 (4.9) kg m −2 vs. 33.8 (3.9) kg m −2 , p = 0.0231] and had greater social deprivation ( P = 0.0003) than non‐users, although otherwise the groups were similar. Weight loss ≥ 2k g was achieved in 30/93 (32%) of RT attempts. At 2 years, those regaining >2 kg and using RT ( n = 60) had mean (SD) weight losses of 7.4 (6.1) kg, with 25 (42%) remissions and 7 (12%) programme withdrawals. Those regaining >2 kg but not using RT ( n = 39) had weight losses of 8.8 (6.0) kg, with 21 (54%) remissions and 4 (10%) programme withdrawals (all not significant). Twelve participants were never recorded as having regained >2 kg or using RTs and, at 2 years, their weight losses were 12.9 (9.2) kg, with 4 (33%) remissions and 8 (67%) programme withdrawals. Conclusions Most people with T2D experience weight regain >2 kg during the 2 years after substantial weight loss with a LED. Only one‐third of RTs corrected their 2‐kg regain, resulting in similar weight losses, remissions and programme withdrawals at 2 years compared to those not using RTs; however, both groups had weight losses below those not recorded as regaining >2 kg during WLM.