Context
Inconsistent findings have been reported regarding improved health-related quality of life (HRQOL) following weight loss.
Objective
To test the efficacy of a weight management program for improving HRQOL in overweight/obese adults diagnosed with type 2 diabetes.
Design
Randomized multi-site clinical trial with two treatment arms and blinded measurements at baseline and end of Year 1.
Setting
Study was conducted at 16 outpatient research centers.
Participants
Total of 5,145 participants (mean age = 58.7±6.9 yr; mean BMI = 36.0±5.9; % women = 59.5%; % white = 63.3%) were randomized to two treatment arms.
Intervention
The two treatment arms were: Intensive Lifestyle Intervention 1 and Diabetes Support and Education (DSE).
Main Outcome Measures
SF-36, physical (PCS) and mental health (MCS) summary scores, and Beck Depression Inventory-II (BDI-II) scores. Baseline means were: PCS = 47.9±7.9; MCS = 54.0±8.1; and BDI-II = 5.7±5.0.
Results
HRQOL, as measured by PCS and BDI-II scores, improved (p<0.001) in the ILI arm compared to the DSE arm. The largest effect was observed for PCS (difference = −2.91, 99% CI: −3.44 ~ −2.37). HRQOL improved greatest in participants with the lowest baseline levels of quality of life. Changes in weight (ILI = −8.77±8.2 kg; DSE = −0.86±5.0 kg), improved fitness, and improved physical complaints mediated treatment effects associated with BDI-II and PCS.
Conclusions
HRQOL was significantly improved in overweight adults diagnosed with type 2 diabetes by enrollment in a weight management program that yielded significant weight loss, improved physical fitness, and reduced physical complaints. Trial Registration: NCT00017953