Measures

Data collection occurs at baseline, 3 months (post-lifestyle sessions), 6 months (post-maintenance phase), and 12 months (Figure 1). The SMSC survey is completed by participants in REDCap on a laptop at the data collection site and reviewed for completeness by study staff. This method is most effective for ensuring that all items are completed accurately and questions men may have about question meaning can be immediately answered.

Strong Men, Strong Communities intervention and assessment timeline.

Primary outcome measures are weight and Diabetes Risk Score (Strong Heart Study, 2011), which is a prediction equation for incident diabetes; specifically, it predicts the risk of type 2 diabetes in the next 4 years for someone who does not currently have diabetes. It was designed for AIs/ANs aged ≥35 years and is based on the following variables: sex, age, waist circumference, hypertension medication (yes/no), systolic and diastolic blood pressure, sisters or brothers with diabetes (yes/no), fasting glucose, A1C, triglycerides, and ratio of urinary albumin and creatinine. A fingerstick sample of blood is collected to assess A1C, glucose, and lipids. A urine sample is collected from each participant for the microalbumin/creatinine test. Blood glucose and plasma levels of high-density lipoprotein (HDL), low-density lipoprotein (LDL), triglycerides, and total cholesterol are measured using the Cholestech LDX System, which measures a complete lipid profile plus glucose in 5 min from a simple fingerstick. The DCA 2000 measures A1C and the microalbumin/creatinine assay measures albumin, creatinine, and the ratio of the two values. Results of the DCA 2000 tests are available in about 6 min. Systolic and diastolic blood pressure are measured twice using an automatic blood pressure cuff and the results are averaged for analysis. Waist circumference is measured and recorded twice using a cloth tape measure. The waist is defined as the midpoint between the highest point of the iliac crest and the lowest point of the costal margin at the midaxillary line. Body weight (kg) and height (cm) are measured using an electronic scale (Tanita BWB800AS) and a stadiometer (Seca 222), respectively. At each timepoint, body weight is measured twice to the nearest 0.1 kg with the participant fully clothed and shoes off using a calibrated balance scale and the two results are averaged. Height is be measured twice to the nearest 0.5 cm with shoes off using a standardized stadiometer and the two results are averaged.

Secondary outcomes measures are change in the individual modifiable Diabetes Risk Score components (i.e., waist circumference, hypertension medication [yes/no], blood pressure, fasting glucose, A1C, triglycerides, and ratio of urinary albumin to creatinine). In addition, the National Cancer Institute’s Fat Screener (National Cancer Institute, 1996) and Fruit and Vegetable Screener (National Cancer Institute, 1998) are used to assess dietary fat and consumption of fruits and vegetables. Both instruments are one to three pages and include food types, frequency of consumption, and quantity. Change in body mass index (BMI) is assessed and computed as body weight in kilograms divided by height in meters squared. Physical activity is assessed with the Modifiable Activity Questionnaire (Pereira et al., 1997), which has previously been used in AI/AN communities (Kriska et al., 1990). Stages of change for diet and exercise and perceived benefits of and barriers to exercise and healthy eating are measured. A 22-item conformity to masculine norms questionnaire (Owen, 2011) is also included in the survey. A social support questionnaire is used to assess family and community support for healthy eating and exercise (Sallis et al., 1987).

Covariates include sociodemographic data such as age, educational attainment, marital status, health conditions, prescription medications, family history of chronic disease, annual household income, employment status, support for healthy eating and physical activity, and alcohol and tobacco use.

Retention is measured as total number of SMSC sessions and data collection visits attended in Months 1–3 (range = 0–12) and Months 4–6 (range = 0–6). Because SDPI-DP found that full participation in all sessions strongly predicted reduced diabetes incidence compared to anything less than full participation (Jiang et al., 2013), binary indicators of full participation in the intervention and maintenance phases will also be calculated. Study retention will be measured as the total number of follow-up data collection visits completed (range = 0–4 for intervention; 0–3 for control) and as binary indicators of completing each individual follow-up visit.