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. Author manuscript; available in PMC: 2015 Jul 1.
Published in final edited form as: Contemp Clin Trials. 2014 Jun 21;38(2):383–396. doi: 10.1016/j.cct.2014.06.010

Table 1.

Overview and Research Design

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)