In this community-based translational trial of a low-intensity, individually tailored, telephone-based lifestyle intervention in at-risk, lower-SES, ethnic minority adults, we had excellent study retention and program compliance and achieved small improvements in several clinical and behavioral risk factors. The intervention group had significantly more weight loss than did the control group, and the net difference in triglycerides, dietary fat intake, and daily fruit and vegetable consumption favored the intervention group after 6 months of intervention.
The weight loss difference of 1.9 pounds between groups at 6 months was small but statistically significant. Nevertheless, it may be clinically relevant because weight loss was the main predictor of reduced diabetes incidence in the Diabetes Prevention Program: every kilogram of weight loss was associated with a 16% reduction in risk for diabetes.38
Additionally, the intervention group had decreased triglycerides, whereas the control group had increased triglycerides from baseline at both time points; hence we observed a large group difference in change in triglycerides. The magnitude of the group difference in triglyceride change (difference of 23.2 mg/dL at 6 months) was comparable to the difference of 17 milligrams per deciliter in the Finnish Diabetes Prevention Study.8
All mean triglyceride levels, however, were lower than the standard 150 milligrams per deciliter threshold value used to designate elevated triglyceride levels.
The reduction in total fat intake (7.7 g/day less for the intervention group at 6 months) was notable because reduction in fat consumption was a strong predictor of lower diabetes risk in the Diabetes Prevention Program.38
We found changes in consumption of fruits and vegetables of 0.6 servings per day at 6 months. The observed effect sizes of these 2 dietary changes were comparable to those found in a systematic review of other physical activity interventions.39
The improvement in self-rated health was notable because self-rated health consistently predicts future health.40–42
No significant group differences were found in fasting glucose or LDL- or HDL-cholesterol levels, waist circumference, and systolic blood pressure. We have 3 possible explanations: (1) some clinical risk factors were in the normal range at baseline; (2) for some factors, although risk reductions were observed in the intervention group, reductions also were seen in the control group; and (3) the intervention may not have been intensive enough to achieve change.
First, our baseline venous fasting glucose level was in the normal range (mean = 94 mg/dL), which may have precluded observing change in this important risk factor. Other clinical risk factors in near-normal range included systolic blood pressure (mean = 127 mm Hg), LDL (112 mg/dL), and HDL (53 mg/dL). These normal values occurred despite efforts to recruit participants at high risk for diabetes based on elevated fasting capillary blood glucose level and self-reported risk factors. This suggests that community-based studies may have more difficulty recruiting people at greatest risk, in contrast to studies in clinical settings where fasting venous blood test screening can be done. Nevertheless, our sample was at moderate to high risk on other risk factors: about 85% were overweight (more than half were obese), 78% of women and 50% of men had elevated waist circumference, 35% fulfilled metabolic syndrome criteria, and almost 50% had a family history of diabetes.
Second, although the intervention group had significant improvements in LDL and HDL cholesterol and a significant reduction in total caloric intake, similar control group improvements precluded observing between-group differences. This may have occurred because diabetes prevention educational materials were part of outreach and recruitment, and control group participants may have changed behavior to some extent without the program. Indeed, at follow-up, 17% of the control group reported having participated in another lifestyle program at some point during the year. In addition, completing the food frequency questionnaire may have raised awareness about diet and portion sizes. Control group improvements have been observed in other diabetes risk reduction interventions. The DEPLOY (Diabetes Education & Prevention with a Lifestyle Intervention Offered at the YMCA) study found significant weight loss in the control group YMCA setting and similarly had provided diabetes education during recruitment.22
Project HEED found significant control group weight loss; qualitative analyses indicated that control group participants believed they benefited from learning that they were at risk and being given information about diabetes.23
Generally, however, such minimal “interventions” are not effective.12
Third, the Live Well, Be Well
program may not have been sufficiently intensive to achieve broad changes. This underscores the substantial challenge to design practical, sustainable programs for underserved populations that obtain risk reductions comparable to those of the Diabetes Prevention Program. One recent community-based translation, Healthy-Living Partnerships to Prevent Diabetes (HELP PD), found significant reductions in fasting glucose level and several other clinical risk factors, but it was a high-intensity program offered to relatively well-educated participants with high levels of risk.26
Designing such programs to be more intensive to achieve greater risk reduction might jeopardize the likelihood of adoption and sustainability by community-based organizations. Live Well, Be Well
conformed to contemporary recommendations for translating diabetes prevention lifestyle programs—namely, to use individually tailored goals, self-monitoring, counselors, and other participants to provide support and a problem-solving approach to overcome barriers.11,43
Live Well, Be Well
also conformed to criteria for an “individually-adapted health behavior change program,” strongly recommended by the Task Force on Community Preventive Services to increase physical activity,44
and behavior change strategies were similar to those in the diabetes prevention trials.12
By designing the Live Well, Be Well
program specifically for lower-SES minority groups that are at higher risk for type 2 diabetes than their counterparts,1–6
this study contributes to the small field of community-based translations aimed at reducing health disparities. Although minority groups are often underrepresented in intervention research,45,46
we obtained a high study retention rate (92%). The other translational intervention designed for underserved groups and tested via a randomized controlled trial design, Project HEED, was a10-week peer-led group-based program offered in community settings to lower-SES Latino and African American overweight adults with prediabetes.23
Participants were thus at higher risk than were those in Live Well, Be Well
. Ninety participants were randomly assigned with 73% study retention. Significant differences in weight loss were reported (at 12 months, the intervention group lost 7.2 pounds compared with 2.4 pounds in the control group; P
< .01); however, they found no other clinical or behavioral changes. Their results are notable because the program was less intensive than Live Well, Be Well
and was delivered by trained peer educators.
Live Well, Be Well is the only community-based translation that used an individually tailored, primarily telephone-based model rather than a group-based model. The use of telephone counseling and neighborhood settings for in-person sessions made it convenient to participate, possibly allowing people to enroll who otherwise could not have participated. Indeed, completion of telephone calls was substantially higher than workshop attendance; thus, a group-based approach may not have been feasible for this population. Also, in participant interviews after program completion, telephone calls were rated as the most useful program feature. Use of public health department infrastructure and staff for intervention delivery has not been tested previously in diabetes risk reduction studies.
Our approach addressed 4 translation priority areas10
by (1) focusing on vulnerable, understudied groups; (2) having few exclusion criteria, thus being more generalizable; (3) being a partnership between researchers and a public health department, thus reflecting their shared perspectives; and (4) being designed to be sustainable by embedding the program in the public health department’s chronic disease prevention program.
The study had several limitations. Implementation in 1 city-level public health department setting limited generalizability. However, agencies with larger service areas (e.g., county-level health departments) might find the telephone-based counseling model more attractive than in-person health education workshops. Additionally, because we had difficulty recruiting men, our sample included only 26% men. Use of fasting screening tests limited generalizability to adults available in the morning, similar to other studies.23
Finally, the significant between-group differences in weight and triglyceride levels were small and may have limited clinical benefit.
Our community-based translational study indicated that the Live Well, Be Well intervention was associated with small changes in a few important diabetes risk factors in lower-SES ethnic minority adults, thus providing a promising approach for future translational efforts to reduce disparities. Because so few community-based models for delivering lifestyle interventions are available, our results suggest that individually tailored programs with telephone counseling should be considered along with the more traditional group-based approaches. Testing lifestyle programs that are integrated into a health department’s chronic disease prevention infrastructure and delivered by public health department counselors in local community venues provides a novel and sustainable goal for translational research.
Future research could adapt Live Well, Be Well and explore the relative effectiveness of variations in program delivery organization (health department, peer educators), delivery mode (group- vs telephone-based), intensity (number of contacts, duration), and risk-level eligibility (overweight, other diabetes risk factors) in terms of risk reduction and program compliance.