Table 2.
Overview of the Original PREMIER EBI and Documentation of Adaptations for Heart Matters Using the Wiltsey-Stirman et al. Coding System
Description of Original PREMIER Content | Description of Heart Matters Content | Level of Adaptation | Type of Adaptation | Source/s of Adaptation (community partner input, focus groups, | Relevant Intervention Mapping Step Coinciding with Adaptations |
---|---|---|---|---|---|
Content modifications: changes made to the intervention procedures, materials or delivery | |||||
Curricula behavioral goals | |||||
Reduce weight by 4.5 kg (10 lb) or more if overweight Limit daily sodium intake to 100 mmol or less Limit fat intake to 30% or less of total kcal No more than 1.0 ounce of alcohol per day for men, and no more than 0.5 ounces of alcohol per day for women Engage in 180 minutes per week or equivalent of moderate physical activity |
If recommended, lose 15 lbs, or your individualized goal Eat 2,400 mg or less of sodium every day Eat 30% or less of total calories from fat No more than two alcoholic drink per day for men, and no more than one alcoholic drinks per day for women Be physically active for 30 minutes per day, three days per week, or accumulate 180 minutes of moderate-intensity each week |
Population | Tailoring/tweaking/refining | Community partner input PREMIER had challenging behavior change and health outcome goals Participants may be discouraged if goals are unrealistic |
Step 2: performance objective matrices |
Intervention dose/duration | |||||
Fourteen 120-minute group sessions and four individual sessions in first 6 months of intervention Twelve group sessions and three individual sessions for 12 months following first 6 months |
Fourteen 90-minute group sessions and four individual sessions in first 6 months 12 group sessions and three individual sessions for 6 months after the first 6 months |
Cohort | Shortening/condensing | Focus group Participants preferred sessions be no longer than 90 minutes Participants preferred a 6- to 12-month intervention |
Step 4: program plan |
Curricula components and materials | |||||
No content/curricula components specifically for adults with mobility limitations Social support emphasized during the maintenance phase only. |
Added special curricula that gives adults with mobility issues strategies for physical activity Family and friends from same household allowed to attend all group session with participant |
Individual population | Adding elements | Focus group Participants expressed the need for modifications for physical activity for those with limited mobility Participants expressed an interest in having family and friends also participate in the intervention for social support |
Step 4: program plan |
Time for group to taste, compare, and discuss different foods discussed during the group session Handouts and participant materials relevant to urban population |
Modified sample food to make it more culturally appropriate and ensure availability in community Handouts and materials amended to reflect relevancy and applicability to rural population |
Population | Tailoring/tweaking/refining | Community partner input Community partners expressed that foods should be types that participants would be most likely to incorporate into their daily diets and materials provided would need to be relevant to a rural community |
Step 4: program plan |
Check-in activity rigid with strict time constraint | Check-in structure and time constraints were loosened | Population | Loosening structure | Community partner input Community partners suggested a shortened check-in to accommodate other session needs |
Step 4: program plan |
Context: changes made to delivery of the same program content, but with modifications to the format or channel, the setting or location in which the overall intervention is delivered, the personnel who deliver the intervention, or the population to which an intervention is delivered. | |||||
Inclusion/exclusion criteria | |||||
Excluded prediabetics Excluded individuals with hypertension |
Included prediabetics Included those with hypertension |
Population | Loosening structure | Academic and community partner input Results of pre-eligibility screening found majority of eligible participants were prediabetic and diabetic In order to have a large enough pool of participants and reach adequate numbers of the community, we revised eligibility criteria |
Step 4: program plan |
Intervention delivery | |||||
Primarily delivered to AA and White populations living in urban areas | Delivered exclusively to AAs living in a rural and semiurban area | Population | N/A | N/A; by nature of our objective the population was different | Step 5: implementation of intervention |
Group sessions delivered at specialized clinical treatment centers Individual one-on-one counseling sessions designed to be delivered in person |
Delivered at communityand faith-based organization facilities Individual sessions amended to be conducted over the phone by facilitators |
Setting | Integrating the intervention into another setting | Community partner input, community assets survey Mistrust in and discomfort of community members with health care institutions Implementation via communityand faith-based organizations would provide improve reach and acceptability Community partners suggested in-person would be difficult owing to time and travel constraints; phone sessions would be convenient for both facilitators and community members |
Step 5: implementation of intervention |
Delivered by staff at specialized centers | Delivered by lay community members | Personnel | Tailoring/tweaking/refining | Community partner input Community partners indicated that the facilitator should be someone relatable in order to ensure retention of participants |
Step 5: implementation of intervention |
Training and evaluation: changes made to the procedures for training personnel or evaluating the program | |||||
Study design and procedures | |||||
Intervention evaluated using a RCT design with three arms | Intervention evaluated using a delayed intervention control RCT design with two arms | Evaluation | Academic and community partners Academic partners expressed budgetary and recruitment constraints Community partners expressed concerns with equitable resources provided to the participants |
Step 6: evaluation | |
Multiple recruitment screening sessions; participants had to meet certain cut-offs to continue through eligibility | One recruitment screening session | Evaluation | Community partner input Community partners expressed concern about participant burden with multiple screening sessions |
Step 6: evaluation | |
Evaluation measures | |||||
Systolic Blood Pressure Data collected at 7 timepoints; prescreening visit, screening visit, baseline, 3, 6, 12, and 18 months |
Weight is primary outcome Four data collection timepoints; baseline, 6, 12 and 18 months |
Evaluation | Academic and community partner input Owing to changes in the inclusion criteria (i.e., inclusion of individuals on blood pressure medications), blood pressure was no longer appropriate Academic partners Resource limitation and participant burden |
Step 6: evaluation |