Abstract P054: Translation of Diabetes Interventions Into Community Settings: 12-month Results of the Lifestyle Intervention for the Treatment of Diabetes Trial
Authors: Bertoni Alain G , Effoe Valery S , Bollhalter Linda , Savoca Margaret R , Puhlman Kristen , Jones Stedman T , Brown W Mark , Dezern Kimberly , Pedley Carolyn F , Bell Ronny A , Katula Jeffrey A 
Published: March 2022

Objective:
Professionally delivered intensive lifestyle weight loss interventions (LWLs) have been shown to improve weight status and CVD risk factors among adults with diabetes in rigorously conducted trials. We report the 12-month results of a trial in which a LWL was delivered by community health workers (CHWs), among predominantly minority and/or lower socioeconomic status participants.

Research Design and Methods:
We recruited overweight or obese adults with diabetes and without CVD primarily via review of electronic medical records and physician referrals. The study featured two 12-month interventions: (1) LWL delivered by trained CHWs in community settings which involved weekly group sessions and 3 individual sessions with an interventionist, or (2) diabetes self-management education (DSM) comprised of 12 monthly group sessions delivered at a primary care clinic. The main outcome was change in United Kingdom Prospective Diabetes Study (UKPDS) estimated 5-year CVD risk at 12 months; secondary outcomes included weight loss, UKPDS risk score components (hemoglobin A1c, blood pressure, lipids) and use of medications affecting these components.

Results:
We screened 1102 and randomized 260 adults (age range 23-83, mean 55.9, 67% female, 48% black, 52% < college degree, mean A1c 7.6%, 37.3% A1c<7%, mean BMI 37.7 kg/m
2
). Baseline demographic and CVD risk factors were equally distributed between the 2 groups of 130 participants each. At 12 months, 92.3% of LWL and 98% of DSM participants were retained. There was not a significant difference in 5-year UKPDS estimated CVD risk by arm (increased from 5.1% to 5.9% in LWL, and 5.5% to 6.1% in DSM, group comparison p=0.61). There was no evidence of effect modification by the pre-specified parameters of gender, race/ethnicity or baseline BMI. Follow-up A1c, SBP, and total cholesterol did not significantly differ by arm. Weight loss was greater in LWL compared to DSM participants (mean of 3.2% vs 1.1% of total body weight, p=0.02). At least 5% weight loss was achieved by 30.8% of LWL and 18.1% of DSM participants (p=0.02). Among LWL participants, 11.7% discontinued their diabetes medication compared to only 1.6% of DSM participants (p=0.005); 87.5% of those who discontinued medication had achieved an A1c<7% at follow-up, compared to 36.8% who continued using diabetes medication. Hypertension and lipid lowering medication use did not differ by arm.

Conclusions:
In a diverse sample of adults with diabetes, a CHW-delivered LWL intervention produced greater weight loss compared to a monthly DSM education, but did not appreciably alter 5-year UKPDS-estimated CVD risk, A1c, or CVD risk factors. The average weight loss achieved (3.2%) may not have been sufficient to produce meaningful changes in metabolic functioning and CVD risk factors, however, some participants in both interventions achieved improved glycemic control without use of medications.