A Community Health Worker-Delivered Intervention in African American Women with Type 2 Diabetes: A 12-Month Randomized Trial.

OBJECTIVE: To evaluate the effectiveness of a community health worker (CHW)-delivered lifestyle intervention for African American women with type 2 diabetes. METHODS: Participants were randomized to either 16 phone-based lifestyle intervention sessions aimed at making small changes in their diet and activity or 16 educational mailings sent across 12 months. Main outcomes included glycosylated hemoglobin (HbA1c), blood pressure (BP), and weight (kg) changes. RESULTS: Two hundred middle-aged (mean = 53 ± 10.24 years), rural, African American women with moderate obesity (mean BMI = 37.7 ± 8.02) and type 2 diabetes (mean HbA1c = 9.1 ± 1.83) were enrolled. At 12 months, the intervention group exhibited no significant differences in HbA1c (-0.29 ± 1.84 vs. + 0.005 ± 1.61; P = 0.789) or BP (-1.01 ± 20.46/+0.66 ± 13.24 vs. + 0.22 ± 25.33/-2.87 ± 1.52; P = 0.100) but did exhibit greater weight loss (-1.35 ± 6.22 vs. -0.39 ± 4.57 kg, respectively; P = 0.046) compared with controls. Exploratory post hoc analyses revealed that participants not using insulin had significantly greater reductions in HbA1c (-0.70 ± 1.86 vs. + 0.07 ± 2.01; P = 0.000), diastolic BP (-5.17 ± 14.16 vs. -3.40 ± 14.72 mmHg; P = 0.035), and weight (-2.36 ± 6.59 vs. -1.64 ± 4.36 kg; P = 0.003) compared to controls not on insulin. CONCLUSIONS: A phone-based CHW intervention resulted in no significant improvements in HbA1c or BP but did demonstrate modest improvements in weight. Women not using insulin showed significant improvements in all primary outcomes.

Barriers and Health Beliefs Related to Weight Management Among Veterans With Human Immunodeficiency Virus.

INTRODUCTION: The success of antiretroviral therapy has led to dramatic changes in causes of morbidity and mortality among U.S. Veterans with human immunodeficiency virus (HIV). Among the 25,000 Veterans treated for HIV, 70% are over age 50 and the rate of obesity has doubled in this population. Veterans with HIV have a 50% increased risk of myocardial infarction yet have limited presence in prevention-related programs designed to lower cardiovascular disease risk. METHODS: This mixed methods study (focus groups, Schwarzer and Renner physical activity, and nutrition self-efficacy questionnaires) was used to explore factors related to health behavior and identify barriers that overweight Veterans with HIV face in enrolling in the MOVE weight management program. Institutional review board approval was granted before the start of the study. All participants were recruited from the Infectious Disease clinic if they met national inclusion criteria for the MOVE weight management program and had not previously participated in the program. Transcribed audio recordings were independently analyzed and coded by four of the researchers using an exploratory process to obtain consensus regarding themes. An interrater reliability analysis for the Kappa statistic was performed to determine consistency among raters. The relationship between physical activity self-efficacy scores and nutrition self-efficacy scores was tested using Spearman's correlation coefficient. RESULTS: The median age of the sample was 56 with high rates of diabetes (36%), hypertension (73%), hyperlipidemia (36%), and tobacco use history (82%). External barriers to participation were discussed in addition to 8 other themes, which influence treatment engagement for Veterans with obesity and HIV including adaptation, stigma, self-management, and support. Veterans held strong beliefs about responsibility and commitment to their health and wanted to assume an active and informed role in their health care. Veterans with high levels of perceived self-efficacy indicated intention to overcome barriers to improve their nutrition and increase their physical activity. Refer to the full manuscript online to see the results in tables. CONCLUSIONS: Despite the chronic life-threatening nature of their condition, Veterans with HIV display a remarkable ability to adapt and commit to their treatment regimen. However, the dual stigma of obesity and HIV was a significant barrier to participation in weight management. This group placed high value on exercise over eating healthier and the importance of social support particularly from their Veteran peers. Focus groups allowed for fluid interaction between group members and researchers, rich conversation, and allowed additional clarification and exploration of topics. One unanticipated effect of the focus groups was that participants may feel less isolated after being a part of the discussion and may develop supportive relationships with their peers. It is possible that participants demonstrated more positive behavioral adaptation or other possible sources of bias. The study findings provide insight into health beliefs and barriers to weight management for all populations struggling with chronic disease and stigma. Data collected will inform future recruitment and retention strategies to engage Veterans with HIV in prevention-related programs designed to enhance long-term health and wellness.

Regimen-Related Distress, Medication Adherence, and Glycemic Control in Rural African American Women With Type 2 Diabetes Mellitus.

BACKGROUND: Regimen-related emotional distress in patients with type 2 diabetes mellitus (T2DM) is associated with poor glycemic control, but the mediators of this relationship are not well described. OBJECTIVE: This cross-sectional study at baseline examines these relationships, including the specific role of medication adherence in rural African American women. METHODS: At baseline in the EMPOWER randomized trial, the investigators collected the following data: Regimen-Related Distress (RRD; subscale of the validated Diabetes Distress Scale), diabetes medications, medication adherence using the Morisky Medication Adherence Scale, and hemoglobin A1C (A1C). RESULTS: The study enrolled 189 rural African American women with T2DM (mean age = 53 ± 11 years, A1C = 9.1% ± 1.8%, body mass index = 37.7% ± 8.2%; 61% on insulin); 56% reported elevated RRD (mean ≥ 3.0), and this was associated with significantly lower medication adherence (4.4 vs 6.4, P < 0.001) and significantly higher A1C (9.5% vs 8.6%, P < 0.001). In multivariate modeling, both elevated RRD (exp ß = 2.1; 95% CI = 1.1-4.2; P < 0.05) and lower medication adherence (exp ß = 3.3; 95% CI = 1.1-9.6; P < 0.05) were independently associated with higher A1C values. In mediation analysis, medication adherence was a significant mediator of the effects of RRD on A1C. CONCLUSION: Among rural African American women with T2DM, elevated levels of RRD were common and were associated with higher A1C values, in part via effects on medication adherence. Complex treatment regimens accompanied by psychological distress may be associated with poorer glycemic control.

EMPOWER: a randomized trial using community health workers to deliver a lifestyle intervention program in African American women with Type 2 diabetes: design, rationale, and baseline characteristics.

BACKGROUND: African American (AA) women with Type 2 diabetes mellitus (T2DM) in the rural south experience less weight loss and poorer glycemic control in traditional diabetes management programs compared to Caucasians. This paper describes the design, rationale, and baseline characteristics from an innovative community health worker (CHW) delivered intervention program in this population. METHODS/DESIGN: This prospective trial randomized rural AA women with uncontrolled T2DM (HbA1c ≥ 7.0) to receive a behaviorally-centered, culturally-tailored lifestyle intervention during 16 contacts from a trained AA CHW or 16 approved diabetes educational mailings. Changes from baseline in glycosylated hemoglobin levels (HbA1c), blood pressure (BP), weight, body mass index (BMI), self-reported dietary and physical activity patterns, and psychosocial measures including diabetes distress, empowerment, depression, self-care, medication adherence, and life satisfaction will be assessed at 6- and 12-months. BASELINE RESULTS: Two hundred AA women (mean age = 53.09 ± 10.89 years) with T2DM from impoverished rural communities were enrolled. Baseline data demonstrated profoundly uncontrolled diabetes of long term duration (mean HbA1c = 9.11 ± 1.82; mean BMI = 37.68 ± 8.20; mean BP = 134.51 ± 20.39/84.19 ± 11.68; 10.5 ± 0.7 years). Self-care behavior assessment revealed poor dietary and medication adherence and sedentary lifestyle. Most psychosocial measures ranged within normal limits. CONCLUSION: The present sample of AA women from impoverished rural communities exhibited significantly uncontrolled T2DM of long duration with associated obesity and poor lifestyle behaviors. An innovative CHW led lifestyle intervention may lead to more effective strategies for T2DM management in this population.

A randomized trial of a small changes approach for weight loss in veterans: design, rationale, and baseline characteristics of the ASPIRE-VA trial.

BACKGROUND: Overweight/obesity rates among veterans are higher than the national average. While weight management treatment has been implemented in the Veterans Health Administration (VHA), program data shows low enrollment, participation, and weight loss. This paper presents the design, rationale and baseline characteristics of a multisite, multi-modality, randomized clinical trial assessing an innovative Small Changes (SC) approach on weight loss compared to the current weight management program in the VHA. METHOD: Overweight/obese veterans were recruited from two VHA medical centers. Participants were randomized to either: 1) sc group, 2) SC phone, or 3) usual care. Participants in the SC arms met with health coaches weekly in months 1-3, bi-weekly in months 4-9, and monthly in months 10-12. Usual care participants met weekly for 12 weeks with limited options for follow-up care. The primary outcome is weight at 12 months. Secondary outcomes include physiological, behavioral, psychosocial outcomes along with participation and adherence. RESULTS: Participants include 481 veterans who are middle-aged (M=55.45, SD=10.00), obese (BMI=36.45, SD=6.24), relatively sedentary (M=4721 steps per day; SD=3115), disabled (52%), men (85%) with a large minority of non-white race/ethnicity (43%) and high prevalence of physical co-morbidities (83%) (Charlson Co-morbidity Index M=1.27, SD=1.75) and mental health disorders (57%) at baseline. CONCLUSION: The present study seeks to determine if an SC approach, delivered either via phone or in-person, will result in greater weight loss and program participation and adherence at 12 months compared to usual care.