Brief formula low‐energy‐diet for relapse management during weight loss maintenance in the Diabetes Remission Clinical Trial (DiRECT)

• Published in: Journal of human nutrition and dietetics Vol. 34; no. 3; pp. 472 - 479
• Main Authors: Brosnahan, Naomi, Leslie, Wilma, McCombie, Louise, Barnes, Alison, Thom, George, McConnachie, Alex, Messow, Claudia Martina, Sattar, Naveed, Taylor, Roy, Lean, Michael E. J.
• Format: Journal Article
• Language: English
• Published: England Blackwell Publishing Ltd 01.06.2021
• Subjects: Body mass; Body mass index; Body size; Body weight loss; Clinical trials; Deprivation; Diabetes; Diabetes mellitus; Diabetes mellitus (non-insulin dependent); Diet; DiRECT; formula low‐energy‐diet; Maintenance; Nutrient deficiency; relapse treatment; Remission; Remission (Medicine); Weight loss; weight loss maintenance; weight regain; weight loss maintenance; weight regain; DiRECT; formula low-energy-diet; relapse treatment
• ISSN: 0952-3871; 1365-277X
• DOI: 10.1111/jhn.12839

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 Results In total, 123/149 (83%) DiRECT intervention participants commenced the WLM phase after 26 (17%) had withdrawn prior to the WLM phase.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. We evaluated brief return to formula low‐energy‐diet (LED) as relapse treatments (RTs) during the weight loss maintenance (WLM) phase of the Diabetes Remission Clinical Trial (DiRECT). Most people with type 2 diabetes experience weight regain >2 kg during the 2 years after substantial weight loss with 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.