OBJECTIVEWe examined the effects of an intensive lifestyle intervention (ILI), compared with a diabetes support and education (DSE) control intervention, on long-term changes in depression symptoms, antidepressant medication (ADM) use, and health-related quality of life (HRQoL) in overweight/obese individuals with type 2 diabetes.RESEARCH DESIGN AND METHODSLook AHEAD was a multisite randomized controlled trial of 5,145 overweight/obese participants assigned to ILI (designed to produce weight loss) or DSE and followed for a median of 9.6 years. The Beck Depression Inventory (BDI) was administered at baseline, annually at years 1–4, and again at year 8. Mean BDI scores and incidence of BDI scores ≥10, indicative of likely mild or greater depression, were examined. Annually through year 10, participants reported their ADM use and completed the Medical Outcomes Study Short Form 36 (SF-36) questionnaire, which yields physical component summary (PCS) and mental component summary (MCS) scores.RESULTSILI significantly reduced the incidence of mild or greater depression symptoms (BDI scores ≥10) compared with DSE (hazard ratio [HR] = 0.85; 95% CI 0.75–0.97; P = 0.0145). Although SF-36 PCS scores worsened over time in both groups, ILI participants reported better physical function than DSE throughout the first 8 years (all P values <0.01). There were no significant differences between treatment arms in the proportion of participants who used ADMs or in SF-36 MCS scores.CONCLUSIONSILI for overweight/obese patients with type 2 diabetes may reduce the risk of developing clinically significant symptoms of depression and preserve physical HRQoL. These findings should be considered when evaluating the potential benefits of ILIs.

Objective. Patients with type 2 diabetes are encouraged to lose weight, but excessive weight loss in older adults may be a marker of poor health and subsequent mortality. We examined weight changes during the post-intervention period of Look AHEAD, a randomized trial comparing intensive lifestyle intervention (ILI) and diabetes support and education (DSE; control) in individuals with overweight/obesity and type 2 diabetes and sought to identify predictors of excessive post-intervention weight loss and its association with mortality. <p>Research Design and Methods. These secondary analyses compared post-intervention weight change (year-8 to final visit [median 16 years]) in ILI and DSE in 3999 Look AHEAD participants. Using empirically derived trajectory categories, we compared four subgroups: Weight Gainers (N= 307), Weight Stable (N=1561), Steady Losers (N=1731) and Steep Losers (N=380) on post-intervention mortality, demographic variables and health status at randomization and year-8.</p> <p>Results. Post-intervention weight change averaged -3.7 ±9.5%, with greater weight loss in DSE than ILI. The steep weight loss trajectory subgroup lost on average 17.7 + 6.6%.; 30% of Steep Losers died during post-intervention follow-up vs 10-18% in other trajectories (p<. 0001). The following variables distinguished Steep Losers from Weight Stable: <i>Baseline </i>- older; longer diabetes duration; higher BMI; greater multimorbidity; <i>Intervention </i>– randomization to control group; less weight loss in years 1-8; <i>Year 8 </i>- higher prevalence of frailty, multimorbidity and depressive symptoms; lower use of weight control strategies. </p> <p>Conclusion. Steep weight losses post-intervention were associated with increased risk of mortality. Older individuals with longer duration diabetes and multi-morbidity should be monitored for excessive, unintentional weight loss. </p>

Approximately 40% of off-treatment pediatric cancer survivors (PCS) are overweight or obese, which increases their risk for negative long-term physical health complications. Consistent with the Institute of Medicine's (IOM) emphasis on patients transitioning from treatment to cancer survivorship and increasing long-term healthy behaviors in these survivors, we plan to conduct a pilot RCT to address the increasing overweight/obesity rates among PCS by targeting their caregivers as agents for PCS behavior change. We plan to focus on parents' behaviors, attitudes and roles in promoting healthier eating and physical activity (PA) in PCS and adapt an evidence-informed, manualized parent intervention - NOURISH - found to be effective for parents of overweight and obese children and adolescents in reducing child and adolescent BMI. We plan to adapt NOURISH for caregivers of 5-12 year old PCS (6 months-4 years off active cancer treatment). Our pilot feasibility RCT - NOURISH-T (Nourishing Our Understanding of Role modeling to Improve Support for Healthy Transitions) evaluates: 1) the preliminary efficacy of NOURISH-T for PCS, compared with an Enhanced Usual Care (EUC) control condition, and 2) factors to consider to improve future adaptations of the intervention. The project will enroll caregivers of PCS at two pediatric oncology clinics into the 6-week intervention (or EUC) with assessments occurring pre- and post-6 weeks of intervention, and at a 4-month follow-up.

Look AHEAD was a randomized clinical trial designed to examine the long-term health effects of weight loss in overweight and obese individuals with type 2 diabetes. The primary result was that the incidence of cardiovascular events over a median follow up of 9.6 years was not reduced in the intensive lifestyle group relative to the control group. This finding is discussed, with emphasis on its implications for design of clinical trials and clinical treatment of obese people with type 2 diabetes.