Table 1.
Sample & Design | Intervention Arms | Outcomes |
---|---|---|
| ||
Participants (n=600) Adult primary care patients at risk for diabetes Participant eligibility criteria Inclusion: Age ≥ 18; BMI ≥ 25; and indicates high risk for developing diabetes, based on the Diabetes Risk Test Calculator 1, 2 Exclusion: Type 2 diabetes diagnosis; Pregnant or becomes pregnant during trial; Contraindication to physical activity or weight loss; No access to phone (those with no access to telephone will be included in the denominator of the reach calculation); Does not speak or read English; Indicates DO NOT CONTACT in medical record Hybrid Preference/RCT Design: Preference (n=240) Randomly assigned to choose either SG/IVR or DVD/IVR intervention arm RCT (n=360) Randomly assigned to one of three groups: SC (n=120); SG/IVR (n=120); DVD/IVR (n=120) |
Standard Care (SC) Single 2-hour small group session and workbook targeting key elements of DPP (e.g., action planning for increased PA, improved nutrition, & weight loss; goal setting, barrier Identification and resolution). Small Group (SG)/IVR 2-hour small group session and workbook identical to SC. 1 live counseling call, 22 tailored IVR calls targeting increased PA, improved nutrition, weight loss, problem solving, participant’s action plan, & staying motivated. Offered for 12 months with final six focused on maintenance and relapse prevention based on DPP’s after core program. DVD/IVR DVD replicating SC and workbook. 1 live counseling call, 22 tailored IVR calls identical to those described above in SG/IVR. |
Reach Number Participation rates Representativeness of participants and non-participants Preference prediction model Effectiveness Weight loss Physical activity Dietary behaviors Quality of Life Adoption (setting) Number, proportion, and representativeness of participating clinics Adoption (staff) Number, proportion and representativeness of participating physicians/providers Implementation Intervention Cost Degree to which intervention is delivered as intended Maintenance Intervention effectiveness at 12- and 18-months Outcomes assessed at baseline, 6, 12 & 18 months |
1Heikes, K.E.; Eddy, D.M.; Arondekar, B.; Schlessinger, L. Diabetes Risk Calculator: a simple tool for detecting undiagnosed diabetes and pre-diabetes. Diabetes care. 2008; 31:1040–1045
2High risk is indicated by score ≥ 5 on Diabetes Risk Calculator (or score ≥ 3 for African-American and Hispanic women ages 40 and below)